Reported trial results for Prostate Cancer
Every Prostate Cancer trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
210 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
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NCT04743934 · results posted 20 July 2026
According to the results reported on ClinicalTrials.gov, this trial involved 44 men in total — 23 received flibanserin combined with androgen deprivation therapy (ADT, a hormone treatment commonly used for prostate cancer), and 21 received a placebo (an inactive dummy treatment) combined with ADT. The trial was measuring whether flibanserin — a medication sometimes used for low sexual desire — had any effect on sexual activity and sexual quality of life in men receiving ADT. Most participants completed the study: 22 out of 23 in the flibanserin group and 19 out of 21 in the placebo group. The reported data shows that, for the main outcome being tracked — the number of participants who said they attempted sexual intercourse at least three times in the month before their assessment — 1 person in the flibanserin group and 3 people in the placebo group reported doing so. For sexual quality of life, the trial used a standardised scoring tool where a score of 50 represents the average in the general population. The reported data shows the flibanserin group scored an average of 39.2, while the placebo group scored 43.2 — both below the population average of 50. The trial also tracked serious unwanted health events (graded as severe or worse on a standard medical scale): 8 such events were reported in the flibanserin group, compared with 5 in the placebo group. No further breakdown of those events was included in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02217709 · results posted 25 June 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 26 people, all of whom received the study drug phenelzine sulfate (a tablet taken by mouth). Twenty of the 26 participants completed the study, while six did not finish. The trial was measuring whether the drug could lower levels of PSA — a protein in the blood often used to monitor prostate cancer — in men with recurrent prostate cancer, and also looked at certain side effects and whether the cancer could be seen to progress on scans. The reported data shows that, out of 26 participants, 1 person had their PSA level drop by 50% or more from where it started after at least 12 weeks of treatment, and 4 people had their PSA level drop by 30% or more from where it started over the same period. For the side effects outcome, the reported data shows that various commonly observed side effects were recorded in 45%, 35%, 30%, 25%, and 10% of participants respectively — though the data as submitted does not specify which particular side effect each percentage refers to. For the outcome measuring how long it took for the cancer to show progression on scans, the data was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04565457 · results posted 6 May 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04565457) enrolled 43 people in total — 32 receiving photon radiation therapy and 11 receiving proton radiation therapy. The trial was comparing two types of CT scanning technology used during radiation treatment planning: a standard cone-beam CT (CBCT) scanner and a research version of the same scanner fitted with a special grid designed to improve image quality. The study measured how accurately each scanner captured tissue density and image clarity, which matters because doctors rely on these scans to plan and guide radiation treatment. The reported data shows several image-quality measurements for the photon therapy group. A key measure called "HU error" — which refers to how far off the scanner's tissue-density readings are from expected values — was reported as a ratio of 1.768, meaning the standard scanner had roughly 1.77 times the density-reading error compared with the research scanner. Image "artefacts" (unwanted visual noise or distortions in the scan) were also compared, with the standard scanner showing about 1.49 times the artefact size of the research scanner. A measure of how well different tissues could be told apart in the image (called contrast-to-noise ratio) showed a ratio of 1.199, meaning the standard scanner's images had approximately 1.2 times the contrast of the research scanner's images. For the proton therapy group (10 people completed), the reported data shows the research scanner had a median reduction in density-reading error of 128.8 units and a median reduction in artefact size of 235.9 units compared with the standard scanner. A secondary measure looked at how accurately computer software could automatically identify body structures in images from each scanner, in the photon group. The reported difference in a similarity score (called Dice coefficient, where a higher score means the computer's outline matched an expert's outline more closely) was −0.065, meaning the research scanner's images scored slightly lower on this automated identification measure than the standard scanner's images. Note that one participant in the proton group did not complete the study, and no reasons were detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04262154 · results posted 24 April 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 28 people across two groups — 20 participants in Cohort 1 and 8 participants in Cohort 2. The trial was measuring what researchers called a "failure-free rate at 2 years." In this context, "failure" was defined as a rise in a specific blood marker (biochemical failure), signs of disease progression on scans, or death from any cause. The trial was tracking how many participants reached the two-year point without any of these events occurring. The reported data shows that in Cohort 1, 13 out of 20 participants were evaluable for the two-year outcome, and of those, 7 were recorded as having remained "failure-free" at two years. In Cohort 2, 7 out of 8 participants were evaluable, and of those, 1 was recorded as failure-free at two years. It is also worth noting that only 3 participants in Cohort 1 and 2 in Cohort 2 were recorded as having completed the study overall, while 17 and 6 respectively did not complete it — the reasons for non-completion were not detailed in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05764005 · results posted 6 March 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05764005) involved 35 participants across two groups — 17 people used an intervention website called MAP (Management of Active surveillance in Prostate Cancer) and 18 people used a control website called MUSIC. The trial was a feasibility study, meaning it was designed to test whether a larger study would be practical to run — not to draw firm conclusions about the tool itself. It looked at things like whether enough people could be recruited, whether participants completed the surveys, and whether participants found the website acceptable to use. The reported data shows that 39 out of a target of 40 participants were recruited in total. Of those recruited, 30 went on to complete both the starting and follow-up surveys. For acceptability — that is, how agreeable participants found the intervention website — participants answered up to seven questions each rated on a scale of 1 to 5 (where 5 means most agreeable). The reported mean (average) scores across those questions were: 3.53, 3.70, 3.30, 2.80, 3.40, 4.40, and 3.60. It is worth noting that the data as submitted does not clearly label which score belongs to which individual question, so a direct breakdown by question cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04288687 · results posted 4 March 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04288687) enrolled 11 participants, all of whom completed the study. The trial was investigating a drug called niraparib, used as a maintenance therapy (ongoing treatment after an initial treatment phase) for prostate cancer. The main thing researchers were measuring was how many participants were still alive and had no signs of their cancer visibly growing on scans at the six-month mark — a measure known as radiographic progression-free survival at six months. The reported data shows that 6 out of 11 participants met that six-month milestone without their cancer showing signs of growth on scans, clinical worsening, or death. For secondary measures — additional things the trial tracked — the reported data shows that 3 participants had their PSA level (a protein in the blood often monitored in prostate cancer) drop by at least 50% from their starting level, and another 3 had it drop by at least 30%. The reported median time to PSA progression (that is, the middle-point estimate of how long it took for PSA levels to start rising again by a defined amount) was 11.2 months. The reported median overall survival — the middle-point estimate of how long participants lived from the start of niraparib therapy — was 24.6 months. It is worth noting that with only 11 participants, this was a very small study, and the data was not reported for any subgroups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05551117 · results posted 9 February 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05551117) enrolled 192 participants across two parts and tested a treatment called MGC018 in people with prostate cancer. The main part of the trial (Part 1) compared two different doses of MGC018 — 2.0 mg (91 participants) and 2.7 mg (90 participants) — against a control group (7 participants). A much smaller Part 2 enrolled just 4 participants. The trial was primarily measuring how many people showed no sign of their cancer spreading on scans at six months (called "radiographic progression-free survival"), as well as how many people's tumours shrank to a meaningful degree. The reported data shows that in Part 1, at the six-month mark, 69% of participants in the 2.0 mg group and 70% in the 2.7 mg group had not shown cancer progression on scans, compared with 47% in the control group. When looking at tumour shrinkage responses, 13.6% of the 2.0 mg group and 30.6% of the 2.7 mg group showed a measurable reduction in tumour size meeting the response criteria, while 0% in the control group did. For those who did respond, the reported data shows the response lasted a median of around 9.4 months in the 2.0 mg group and 9.1 months in the 2.7 mg group. A blood marker for prostate cancer (PSA) dropped by 50% or more in 45.8% of the 2.0 mg group and 38.0% of the 2.7 mg group. In the very small Part 2 (4 participants), the reported tumour response rate was 0%, though the extremely small number of participants means this figure should be interpreted with great caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04497844 · results posted 22 January 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04497844) enrolled 348 participants in each group — one group received niraparib combined with abiraterone acetate plus prednisone, and the other received a placebo combined with abiraterone acetate plus prednisone. The trial was studying men with prostate cancer that had spread, focusing on participants whose tumours had certain gene changes (called HRR gene mutations, including a specific type called BRCA mutations). The main thing being measured was how long participants went without their cancer visibly growing or spreading on scans — known as "radiographic progression-free survival" — tracked across three overlapping groups defined by their gene mutation type. The reported data shows that, for the placebo-plus-abiraterone group, the median time before cancer showed visible growth on scans was approximately 26 months in the BRCA mutation subgroup, around 27.6 months in the broader HRR gene mutation subgroup, and about 29.5 months across the full group of all HRR participants. For the niraparib-plus-abiraterone group, the same figures were recorded as "NA" (not available/not reached), meaning the data was not reported or a median could not be calculated at the time of reporting. For the secondary outcome — how long until participants experienced physical symptoms worsening — the reported data shows "NA" for both groups across all three subgroups, meaning those figures were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03503344 · results posted 21 January 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT03503344) enrolled 26 people with prostate cancer, split evenly into two groups of 13. One group received a drug called apalutamide on its own (Arm A), while the other group received apalutamide combined with a focused radiation treatment called stereotactic body radiotherapy, or SBRT (Arm B). All 26 participants completed the study. The main thing the trial was measuring was the proportion of participants whose prostate-specific antigen (PSA) — a protein in the blood often used to monitor prostate cancer — fell to an undetectable level (below 0.2 ng/mL) at six months after finishing the apalutamide treatment, which was 18 months from when they were assigned to their group. The reported data shows that in Arm A (apalutamide alone), none of the participants (0 out of 13) had an undetectable PSA level at that time point. In Arm B (apalutamide plus SBRT), the reported proportion was 0.308, meaning roughly 4 out of 13 participants had an undetectable PSA level at that point. For a secondary measure — the middle point of time before PSA levels started rising again (called median time to PSA progression) — Arm A recorded approximately 13.82 months, while this figure was not able to be calculated for Arm B and was recorded as not available. The reported data also shows that a small number of treatment-related side effects were recorded across both arms, though the full breakdown of these figures across the various categories listed was not completely detailed in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05457257 · results posted 19 December 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05457257) enrolled 43 men with prostate cancer — 29 received olaparib (300 mg twice daily) and 14 received an "investigator's choice" of a standard hormone-blocking medicine (called a next-generation hormonal agent, or NHA). The trial was primarily measuring how long participants went without their cancer visibly growing or spreading on scans — a period called "radiological progression-free survival." Several secondary measurements were also tracked, including overall survival, PSA (prostate-specific antigen) levels in the blood, pain-related outcomes, and bone complications. The reported data shows that, for the primary measure, participants in the olaparib group went a median (the midpoint value across the group) of approximately 9.3 months before their cancer progressed on scans or they died, compared with approximately 8.8 months in the NHA group. For the secondary measures: 5 out of 29 participants in the olaparib group and 1 out of 14 in the NHA group had a confirmed measurable shrinkage of their tumour. Median overall survival was reported as approximately 17.3 months in the olaparib group; a figure for the NHA group was not reported in the data. Regarding PSA response (a drop of 50% or more in PSA levels), the reported data shows figures of 48% and 41% for the olaparib group and 36% and 29% for the NHA group — though the reason two figures appear for each group was not explained in the submitted data. Time to a first bone complication was not reported for either group, and time to needing opioid pain relief was not reported for the olaparib group, while approximately 17.3 months was recorded for the NHA group. It is also worth noting that the data shows zero participants were recorded as having "completed" the trial in either group, with all participants listed under "not completed" — no further explanation for this was provided in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04446117 · results posted 18 December 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04446117) enrolled 575 people with prostate cancer — 289 assigned to the experimental group receiving a combination of two medicines called cabozantinib and atezolizumab, and 286 assigned to the control group receiving a standard hormonal therapy (either abiraterone or enzalutamide). The trial was measuring two main things: how long participants went without their cancer visibly growing or spreading on scans (called "progression-free survival"), and how long participants lived overall ("overall survival"). The reported data shows that, for progression-free survival, participants in the experimental group went a median of approximately 6.3 months before their cancer progressed or they passed away, compared with approximately 4.2 months in the control group. (Median means half the people in each group reached that point sooner, and half took longer.) For overall survival, the reported median was approximately 14.8 months in the experimental group and approximately 15.0 months in the control group — figures that were very close to each other. These numbers reflect what was observed across the study group as a whole, and individual experiences varied. It is worth noting that a relatively small number of participants — 22 in the experimental group and 20 in the control group — were recorded as having fully completed the study, with the majority having discontinued at various stages, which the data does not fully explain. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05470699 · results posted 17 December 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 34 participants and was designed to test the imaging performance of a specialised radiotherapy machine called the X1 RefleXion Medical Radiotherapy System (RMRS). The machine has a built-in PET-CT scanner — a type of medical imaging that can detect areas of activity in the body. Participants received both a standard PET-CT scan using a tracer called \[18F\]-DCFPyL (which targets prostate cancer cells) and a PET-CT scan performed on the X1 machine itself. Of the 34 people who started the trial, 20 completed it and 14 did not complete it; the reasons for non-completion were not detailed in the reported data. The reported data shows that for the primary outcome — whether tumours could be clearly seen on the X1 machine's PET scan — the result recorded was 1 participant. It is worth noting this figure appears unusually low relative to the number of completers, and no further breakdown was provided in the submitted data to explain this number. For the secondary outcome, the trial looked at how many participants' X1 scan data could be used to generate an acceptable treatment plan for a type of radiation therapy guided by the PET images (called biology-guided radiotherapy). The reported data shows that for 18 participants, the imaging data from the X1 machine led to a plan that the principal investigator considered acceptable. It should be noted that the data as submitted does not include explanatory context for some of the figures, so readers should be cautious about drawing conclusions from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05696444 · results posted 25 November 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 137 people across three types of robotic-assisted urological surgery using a system called Hugo: 55 people had a prostatectomy (removal of the prostate), 29 had a cystectomy (removal of the bladder), and 53 had a nephrectomy (removal of a kidney). The trial was measuring how often the robotic surgery could be completed without needing to switch to a different surgical approach, as well as tracking complications and other details about how the operations went. The reported data shows that 134 out of 137 participants completed their surgery without the surgical team needing to switch away from the Hugo robotic system. Regarding serious complications — defined as those requiring further surgical, endoscopic, radiological, or intensive care intervention, or resulting in death (graded III to V on a standard surgical complication scale) — the reported data shows 2 participants in the prostatectomy group, 5 in the cystectomy group, and 1 in the nephrectomy group experienced complications at this level. For any complication of any severity within 30 days, the reported figures were 31 out of the combined group with available data, 24 in the cystectomy group, and 24 in the nephrectomy group (noting the prostatectomy group appears to be included within the combined figure). Average operating times were reported as approximately 228 minutes for prostatectomy, 358 minutes for cystectomy, and 179 minutes for nephrectomy. Average estimated blood loss during surgery was reported as approximately 162 mL, 395 mL, and 118 mL respectively. Blood transfusions within 30 days were reported for 0 prostatectomy participants, 9 cystectomy participants, and 1 nephrectomy participant. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05407311 · results posted 17 November 2025
According to the results reported on ClinicalTrials.gov, this trial tested an investigational imaging agent called 64Cu-SAR-BBN — a radioactive tracer designed to be used in PET scans. The trial enrolled 53 participants, of whom 43 completed the study and 10 did not. The trial was measuring two main things: how often side effects occurred, and how accurately the tracer identified true positive findings (areas of disease correctly detected by the scan) compared to a reference standard. Scans were taken on two separate days — Day 0 and Day 1 — to compare how the images looked at different time points after the tracer was given. The reported data shows that, for side effects, 8 out of 53 participants experienced treatment-emergent adverse events (unexpected health changes that occurred after receiving the tracer), and 2 participants had what are classified as serious adverse events. No severity grade details were broken down further in the submitted data. For scan accuracy, the proportion of participants whose scans correctly detected a true positive finding — called the Correct Detection Rate — was reported as 14.9% on Day 0. On Day 1, this figure ranged from 4.3% to 14.9% depending on which of the three independent reviewers assessed the scans. A separate measure called Positive Predictive Value (roughly, how often a positive scan result actually reflected a true finding) ranged from 22.6% to 47.1% on Day 0 and from 22.2% to 37.5% on Day 1, again varying by reviewer. The reported data also includes a secondary measure called SUVmean — a way of quantifying how much of the tracer was taken up in different body regions such as lesions, soft tissue, and bone. These values ranged from approximately 2.4 to 6.4 across the three independent reviewers on Day 0, though a full breakdown across all time points and body regions was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05220501 · results posted 10 November 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05220501) involved three groups of men undergoing prostate biopsy. A total of 802 participants started the study across the three groups: 137 in the microultrasonography-only group, 263 in the microultrasonography-plus-MRI group, and 402 in the MRI-plus-conventional ultrasound group. The trial was measuring how often each imaging-guided biopsy approach detected a type of prostate cancer considered clinically significant (defined as Gleason Grade Group 2 or higher — a way of classifying how abnormal cancer cells look under a microscope, with higher numbers generally meaning more abnormal). Not all participants completed the study: 121, 226, and 331 finished in each respective group. The reported data shows that for the primary outcome — comparing microultrasonography-guided biopsy against MRI-plus-conventional-ultrasound-guided biopsy — 160 participants in the microultrasonography group and 141 participants in the MRI/conventional ultrasound group had clinically significant prostate cancer detected. For the secondary outcome — comparing the combination of microultrasonography-plus-MRI against MRI-plus-conventional-ultrasound — the reported data shows 106 participants in the microultrasonography/MRI group and 141 in the MRI/conventional ultrasound group had clinically significant prostate cancer detected. These figures represent the raw number of participants in whom cancer of that grade was found in each group. It is worth noting that the groups were of different sizes, so the raw numbers alone do not tell the full story of how the approaches compared proportionally — and no further breakdown of that comparison was included in the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03507608 · results posted 16 October 2025
According to the results reported on ClinicalTrials.gov, this trial involved a total of 19 people across two phases. In the first phase, 6 participants received the drug flutamide in an open-label "run-in" period (meaning everyone knew what they were taking). Then, in the second phase, 19 participants were randomly assigned in a blinded way (meaning neither the participants nor the researchers knew who was getting what) to receive either flutamide (14 people) or a placebo — a dummy treatment with no active ingredient (5 people). All 19 people in the second phase completed the trial. The trial was measuring whether flutamide causes a specific type of damage to prostate cancer cells — known as DNA double-strand breaks — in men whose prostate cancer was already being managed with hormone-suppressing treatment. The reported data shows that the primary outcome was expressed as a "fold-change," which is a way of describing how much a measurement went up or down compared to a starting point. A result below 1 means the measurement decreased, while a result above 1 means it increased. According to the results reported on ClinicalTrials.gov, the flutamide group had a reported fold-change of 5.86, meaning the level of DNA double-strand breaks was measured as approximately 5.86 times higher after flutamide exposure compared to before. No corresponding number was reported for the placebo group in the data submitted. It is worth noting that this was a small trial with fewer than 20 participants in total, and the placebo group result was not included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03217747 · results posted 14 October 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03217747) enrolled a total of 114 participants spread across 14 different treatment groups. The groups tested different combinations and timing schedules involving a drug called avelumab (a type of immunotherapy) sometimes alongside chemotherapy and/or radiation therapy (referred to as XRT), across Arms A through F. The trial was primarily designed to look at whether certain serious side effects — called dose-limiting toxicities, or DLTs — occurred during the early part of treatment. Researchers also tracked whether participants' tumours responded to treatment, and whether their disease stayed stable or was controlled over time. The reported data shows that, for the primary outcome, zero participants across all 12 groups for which data was reported experienced a dose-limiting toxicity. For the secondary outcomes — which looked at how tumours responded — the numbers were generally very low across the groups. Using standard tumour-measurement criteria (RECIST v1.1), only 1 participant (in one group of Arm A) showed what is called an "objective response," meaning a meaningful shrinkage of their tumour. Using a slightly different immune-focused measurement system (irRECIST), 2 participants total across all groups showed an objective response. When looking at "clinical benefit" — which includes tumour shrinkage or disease that stayed stable for at least 6 months — the reported data shows small numbers across a handful of groups, with the highest being 3 participants in one Arm A group. For most groups, the reported figure was zero. Data for some groups and some outcome measures was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04158245 · results posted 22 September 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04158245) enrolled 9 people, all of whom had a form of advanced prostate cancer that had spread to other parts of the body and was no longer responding to standard hormone treatment. The trial was measuring how well a specialised type of scan — called an 18F-fluciclovine PET scan — could track changes in participants' cancer after they started certain treatments. Participants had one scan before starting treatment and another scan 12 weeks later. Eight of the 9 participants completed the study; one did not complete it, though the reason was not reported in the data. The reported data shows that, when the PET scans were assessed using a standardised scoring system (called PERSIST 1.1, which places each participant's scan result into one of four categories — stable disease, progressive disease, partial response, or complete response), out of 8 participants who completed scanning: 5 were categorised as having stable disease, 3 were categorised as having a partial response, and none were categorised as having either progressive disease or a complete response. The reported data also shows a comparison between the PET scan and more conventional scans (CT scan and bone scan): before treatment, 8 participants had findings on the PET scan and 3 had findings on the conventional scans; at 12 weeks, 8 participants had findings on the PET scan and 3 had findings on the conventional scans. No further breakdown of this comparison was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04702737 · results posted 12 September 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04702737) enrolled 41 people in a single group receiving a drug called tarlatamab, with 40 of them actually receiving the treatment. Only 1 participant was recorded as completing the study, while 40 did not complete it — though the data does not explain the reasons for this in detail. The trial was primarily measuring how many participants experienced unwanted medical events (called adverse events) after receiving tarlatamab, as well as looking at how the cancer responded to the treatment. The reported data shows that all 40 participants who received tarlatamab experienced at least one unwanted medical event that started during or shortly after treatment (known as a treatment-emergent adverse event). All 40 were also reported to have experienced at least one adverse event that the treating doctor considered could reasonably be related to the tarlatamab itself. One participant out of 40 was reported to have experienced a particularly serious type of early adverse event known as a dose-limiting toxicity — meaning a reaction severe enough, within the first 28 days, to potentially limit how much of the drug could be given. The reported data shows that 12% of participants had their tumour shrink or disappear to a measurable degree (called an objective response). The typical time from first treatment until the cancer was recorded as progressing or the participant died was reported as 2.1 months. The data for how long responses lasted in those who did respond was not reported (shown as "NA" in the submitted data). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05590793 · results posted 9 September 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 195 people, all of whom received a single injection of a 6-month formulation of triptorelin pamoate — a hormone-based treatment used in prostate cancer care. Of those who started, 188 completed the trial and 7 did not. The trial was primarily measuring whether the treatment could lower a hormone called testosterone to what doctors call "castrate level" (below 50 nanograms per deciliter in the blood), and whether that low level could be maintained over time. It also tracked changes in a prostate-related protein in the blood called PSA (prostate-specific antigen), how the drug moved through the body, and any unwanted medical events that occurred. The reported data shows that 99.5% of participants reached the target low testosterone level by Day 29 (roughly one month after the injection). The reported data also shows that 100% of participants who reached that low level by Week 8 maintained it through to Week 24 (about six months). Regarding PSA — a protein often monitored in prostate conditions — the reported figures show an average decrease of approximately 90.7% from the starting level by Week 12, and approximately 92.2% by Week 24. For how the drug moved through the body, the reported data shows that the highest concentration of the drug in the blood was reached at around 2.95 hours after injection, with a peak level of 44.5 nanograms per millilitre. On the secondary measure tracking unwanted medical events, the reported data shows that 160 out of 195 participants experienced at least one treatment-emergent adverse event (an unexpected medical occurrence happening after the injection), 8 participants experienced a serious adverse event (defined as one involving hospitalisation, being life-threatening, causing significant disability, or other medically important outcomes), and 7 participants had a local reaction at the injection site. The trial did not distinguish between events considered related or unrelated to the treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03317990 · results posted 4 September 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03317990) enrolled 407 men in total — 204 in the NeuroSAFE group and 203 in the standard (control) group — who were undergoing robotic-assisted surgical removal of the prostate. Of those, 190 and 191 respectively went on to have surgery, and around 174 in each group completed the trial. The trial was measuring erectile function at 12 months as its main goal, along with bladder control and cancer-related outcomes as secondary goals. The NeuroSAFE procedure involves an additional step during prostate surgery intended to guide how much nerve tissue is preserved. The reported data shows that on the erectile function questionnaire (the IIEF-5, scored from 5 to 25 where higher means better function), the NeuroSAFE group averaged a score of 12.7 at 12 months, compared with 9.7 in the control group. For bladder control at 3 months (scored 0–21, where lower means fewer problems), the NeuroSAFE group averaged 5.8 versus 7.4 in the control group; at 6 months those figures were 4.5 and 5.1 respectively. Regarding cancer-related outcomes, the reported data shows that in the NeuroSAFE group, 7 men had persistently raised PSA (a protein used to monitor prostate cancer), 10 had a later rise in PSA, 8 received early additional treatment, and 157 had no recurrence or additional treatment. In the control group, the corresponding numbers were 5, 7, 2, and 174. Quality of life data using the EQ-5D-5L questionnaire was listed as a secondary outcome but no results were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05458856 · results posted 23 July 2025
According to the results reported on ClinicalTrials.gov, this trial looked at a medication called triptorelin embonate (22.5 mg), given by injection, in men whose treatment required lowering testosterone to very low levels (sometimes called "castrate" levels). A total of 147 participants started the trial, 145 received the treatment, and 134 completed the study. The trial tracked testosterone levels in the blood at several set points over roughly 12 months to see how many participants maintained testosterone below a specific threshold (50 ng/dL, a standard cut-off used in this type of treatment). The reported data shows that, overall, 95% of participants maintained testosterone below that threshold across all the scheduled measurement points throughout the study. Looking at each individual check-in — on Days 29, 85, 141, 169, 253, 309, and 337 — the reported percentages of participants below that threshold were 100%, 100%, 98.3%, 97.5%, 100%, 99.2%, and 99.2% respectively. The trial also measured a stricter threshold (20 ng/dL), and the reported data shows that 83.3% of participants fell below that lower level at some point during the study. At each individual time point, the figures for that stricter threshold ranged from 92.5% up to 98.3%. The study also checked testosterone levels just 3 and 7 days after each injection, with reported percentages ranging from 92.5% to 98.3% across those early time points. The reported data also shows that a blood marker called PSA (prostate-specific antigen, a protein measured in the blood) was tracked at Days 169 and 337. The reported percent change from the starting level was recorded as 0.00% at both time points, though it is worth noting that the way this figure was calculated — as described in the trial record — means it may not straightforwardly reflect an absence of change, and no further breakdown of individual PSA values was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03448458 · results posted 17 July 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 17 people, with 16 completing the study and 1 not completing it. The trial used a specialised type of medical scan called a Gallium Ga 68-DOTATATE PET/CT scan — a imaging technique that can detect certain proteins on tumour cells — to look at how much of the scan's tracer was taken up by different areas of disease in participants. The goal was to examine whether the level of tracer uptake seen on the scan was linked to how long participants went without their disease progressing. The reported data shows that, when looking at tracer uptake across participants, 11 people showed uptake in one category of lesion (area of disease), 4 in another category, and 1 in a further category — though the data as submitted does not label these categories in detail. For the secondary outcome, the trial measured "progression-free survival," which means the length of time participants went without their disease getting worse. The reported data shows figures of 8.1 months, 13.3 months, and 36 months recorded across the group, though the data as submitted does not provide a full breakdown of exactly how these three figures were defined or which subgroups they applied to. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05547386 · results posted 9 July 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 163 people, all of whom received a PET/CT scan using a radioactive tracer called 68Ga-PSMA-11 (a substance that can help make prostate cancer cells visible on a scan). Of the 163 who started, 156 completed the study, and 7 did not complete it. The trial was observational, meaning researchers were watching and recording what happened rather than testing a new treatment. The main thing being measured was whether any participants experienced unexpected unwanted reactions after being injected with the tracer, from the time of the injection until they left the nuclear medicine department. The reported data shows that out of all 163 participants, zero people reported any unexpected adverse reactions (that is, unexpected unwanted effects) during the observation period. This was the only outcome measure for which results were submitted to ClinicalTrials.gov — no other outcome measure results were reported in the structured data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05288166 · results posted 27 June 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05288166) enrolled 463 people in the abemaciclib group and 462 people in the placebo group — a total of 925 participants — all of whom had prostate cancer. The trial was measuring several things over time, including how long participants went without their cancer visibly progressing on scans (called radiographic progression-free survival), how long before their cancer became resistant to hormone-lowering treatment, how long they survived overall, how long before pain got worse, and how their quality of life changed. The reported data shows that for most of the outcomes — including scan-based progression-free survival (assessed both by the treating doctors and by an independent review team), survival free from treatment-resistant prostate cancer, overall survival, and quality-of-life deterioration — the values were listed as "NA" (not available), meaning those figures were not reported in the submitted data. For the measure of time to pain progression, a figure was only reported for the placebo group (19.13 months); no corresponding number was reported for the abemaciclib group. The reported data does not provide enough information to compare the two groups on most of these outcomes. It is worth noting that only a small number of participants — 47 in the abemaciclib group and 39 in the placebo group — were recorded as having completed the study, while the large majority did not complete it, though the reasons for this are not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04461509 · results posted 29 May 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04461509) looked at whether advanced imaging techniques — specifically a type of MRI called high-resolution MRI (hrMRI) and a type of PET scan using a tracer called 18F-PSMA — could find prostate cancers that a standard MRI scan might miss. The trial had two groups: one group of 29 people who were due to have a procedure called HIFU (High-Intensity Focused Ultrasound, which uses sound waves to target prostate tissue), and another group of 33 people who were due to have surgical removal of the prostate (called a radical prostatectomy). Overall, 24 people in the HIFU group and 32 people in the prostatectomy group completed the study. The reported data shows that, in the HIFU group, 8 participants were found to have biopsy-confirmed (tissue-sample confirmed) cancers that the standard MRI would have missed but that were picked up by the advanced imaging. The data also reported 85 cancerous zones detected (any cancer grade) and 49 cancerous zones detected at a higher grade of aggressiveness, though the full context for how these two figures relate to each other was not separately detailed in the submitted data. Regarding follow-up after the HIFU procedure, the reported data shows that 17 and 18 participants (reported across two measurement points) had negative biopsies — meaning no cancer was found in tissue samples — at six months. For the prostatectomy group's secondary outcome (looking at how accurately the imaging identified or ruled out tumours), no numbers were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02875223 · results posted 20 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT02875223) tested a drug called CC-90011 across two parts. In Part A, the trial enrolled 50 people across nine different dose levels — ranging from 1.25 mg up to 120 mg — to find out how much of the drug could be given before serious side effects (called "dose-limiting toxicities," meaning harmful reactions that occur within the first treatment cycle and set the upper limit of a safe dose) became too common. Part B enrolled a further 25 people across four specific cancer groups (lung neuroendocrine tumours, a prostate cancer subtype, a type of lymphoma, and a Japanese patient group), all receiving 60 mg. No participants were recorded as having completed the study in any group, though the data does not explain why. The reported data shows that in Part A, no dose-limiting toxicities were recorded at the five lowest dose levels (1.25 mg through 20 mg). One such toxicity was reported at 60 mg, two at 80 mg, and four at the highest dose of 120 mg. For tumour response in Part A, the reported data shows that the percentage of participants whose tumours shrank significantly (a "partial response") or held stable for at least four months was: 0% at 1.25 mg, 0% at 2.5 mg, 16.7% at 5 mg, 0% at 10 mg, 20% at 20 mg, 50% at 40 mg, 33.3% at 60 mg, 30% at 80 mg, and 0% at 120 mg. The only dose group where any participant's tumour shrank by 30% or more was the 80 mg group, at 10%. How long that response lasted was not reported in the submitted data. The reported median time until disease worsened (progression-free survival) ranged from 51.5 days to 588 days across the dose groups, and the reported median overall survival ranged from 139 days up to figures that could not be calculated in the 20 mg, 40 mg, and 60 mg groups — meaning not enough participants in those groups had died by the time data was collected to produce a figure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04383210 · results posted 3 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04383210) enrolled a total of 54 participants, split across three groups: Cohort 1 (36 people), Cohort 2 (11 people), and Cohort 3 (7 people). All participants who started the trial also completed it — none dropped out. The trial was measuring something called the "objective response rate," which refers to the proportion of participants whose tumours showed a meaningful reduction in size (either disappearing completely or shrinking by at least 30%) as measured by standard medical imaging such as CT or MRI scans. The reported data shows that, in Cohort 1, 10 out of 36 participants had their tumours meet the criteria for a meaningful reduction in size. In Cohort 2, 1 out of 11 participants met that same threshold. In Cohort 3, 0 out of 7 participants had a response that met the criteria. These numbers reflect what the treating doctors observed and recorded during the study. No secondary outcome data was included in the results submitted to ClinicalTrials.gov, so further detail on other measures is not available from this source. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05680675 · results posted 6 February 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 50 participants across three groups. Fifteen people were in a group receiving two types of PET/CT scans using FDG and Cu64-DOTATATE tracers, another 15 received FDG and Ga68-DOTATATE scans, and 20 received FDG and PSMA scans. A PET/CT scan is a type of medical imaging that takes detailed pictures of the inside of the body. All participants in every group completed the study — no one dropped out. The trial's main purpose was to collect imaging data that could be used to develop new techniques for combining two different scanning tracers into a single scan session, rather than needing two separate sessions. The reported data shows that the primary thing being measured was simply whether each participant successfully completed their two assigned PET/CT scans. The reported numbers show that a total of 30 scans were completed in the FDG + Cu64-DOTATATE group (15 participants × 2 scans each), 30 scans in the FDG + Ga68-DOTATATE group, and 40 scans in the FDG + PSMA group. In other words, every scheduled scan across all three groups was reported as completed. The data collected from these scans was intended to help researchers develop and refine computer processing methods for a future technique that could run two tracers simultaneously in one scan. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01540994 · results posted 16 January 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT01540994) enrolled 12 participants, all of whom completed the study — none dropped out. The trial involved a single group of people who received a type of targeted radiation treatment for prostate cancer called Stereotactic Body Radiation Therapy (SBRT), which delivers precisely aimed, high-dose radiation over a small number of sessions. The trial was measuring two main things: first, any side effects affecting the urinary tract or lower bowel (both during and after treatment), scored on a standard scale from 0 to 5 where higher numbers mean more severe effects; and second, whether participants' PSA levels (a protein in the blood used to monitor prostate cancer) remained low after treatment. The reported data shows that, for side effects occurring *during* radiation (called "acute" effects), 11 out of 12 participants scored 0 — meaning no detected side effects on that scale — and 1 participant scored 4, which represents a more severe rating. No participants scored 1, 2, or 3. For side effects occurring *after* radiation was completed (called "late" effects), all 12 participants scored 0 on that same scale. For the secondary outcome, the reported data shows that 10 out of 12 participants were classified as "biochemically disease-free" — meaning their PSA had not risen by 2 ng/ml or more above their lowest recorded post-treatment level. Results for the remaining 2 participants in this category were not reported in detail in the data provided. It is worth noting that this was a very small trial of only 12 people, and the data as submitted does not include information about how long participants were followed up. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04951492 · results posted 1 January 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 2 participants, both of whom completed the study. The trial was testing a drug called olaparib in people with prostate cancer, and it was measuring a number of things including changes in a blood marker called PSA (prostate-specific antigen, a protein that can be tracked in prostate cancer), tumour size on scans, how long participants went without their cancer progressing, and survival. The reported data shows that for the primary goal — whether at least half the participants achieved a 50% drop in their PSA levels from the start of treatment — the result was 0 out of 2 participants. For the secondary measures, 0 out of 2 participants showed a meaningful reduction in tumour size on scans. The reported data shows that the median time before cancer showed signs of progressing on scans was 12.3 weeks, and the median time before PSA levels progressed was 12 weeks. ("Median" here simply means the middle value in the group.) Regarding overall survival, 0 participants died during the study period, though the trial notes this particular measure was originally planned to track time from enrolment to death. It is worth noting that with only 2 participants, this was an extremely small study, and the reported figures reflect only those 2 individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03707184 · results posted 29 November 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 17 participants, with 15 completing the study and 2 not completing it. All participants were in a single group that received a radioactive tracer called Fluciclovine F18, followed by a type of body scan called a PET/CT scan. The trial was measuring how much of the tracer was taken up by different types of bone lesions (areas of abnormal bone), using a scoring system called the Standardised Uptake Value, or SUV — a number that reflects how much of the tracer collected in a particular spot in the body. The reported data shows two sets of SUV measurements across four types of bone lesions. The first set measured the average (mean) uptake in each lesion type: dense bone-forming lesions recorded 1.91, ground-glass bone-forming lesions recorded 2.36, mixed bone-forming lesions recorded 2.63, and bone-dissolving lesions recorded 3.05. The second set measured the peak (maximum) uptake in each lesion type: dense bone-forming lesions recorded 4.80, ground-glass bone-forming lesions recorded 7.17, mixed bone-forming lesions recorded 8.39, and bone-dissolving lesions recorded 10.02. No secondary outcome measures were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03400150 · results posted 30 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03400150) involved 222 participants in total — 143 people in the "ProSpace" balloon group and 79 people in a control group. The trial was looking at two main things: first, whether a balloon spacer device (placed between the prostate and the rectum before radiation treatment for prostate cancer) caused no more rectal, device, or procedure-related side effects than the control group within 6 months; and second, whether the balloon reduced the amount of radiation reaching the rectum by a meaningful amount in those who received it. The reported data shows that, for the safety measure, 25 out of 143 participants in the balloon group experienced a rectal, device, or procedure-related adverse event (an unwanted effect) rated above Grade 1 (meaning more than mild) within 6 months, compared with 18 out of 79 participants in the control group. For the efficacy measure, the reported data shows that 139 out of 143 balloon group participants were recorded as achieving a greater than 25% reduction in the amount of radiation reaching a specific part of the rectum (the volume receiving 70 Gray, a unit of radiation dose) — the trial had pre-set a benchmark that this finding would be confirmed if more than 75% of balloon recipients reached that level of reduction. It is worth noting that the results data as submitted does not include further statistical detail beyond these participant counts, so additional context about how these numbers were interpreted is not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02555397 · results posted 10 October 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people in total, split into five groups of three participants each. Each group received a different dose of an adenovirus-based treatment (referred to as "AdV"), with doses ranging from the lowest (1×10¹⁰ viral particles) to the highest (1×10¹² viral particles). The trial was primarily looking at whether higher doses caused more toxicity — that is, whether harmful reactions occurred more often as the dose went up. Fourteen of the fifteen participants completed the study; one person in the lowest-dose group did not finish. The reported data shows the following numbers of participants who experienced dose-dependent toxicity in each group: zero out of three in the lowest-dose group, two out of three in the second group, zero out of three in the third group, two out of three in the fourth group, and three out of three in the highest-dose group. The remaining measurements in the primary outcome data appear incomplete as reported. For all six secondary outcomes — which were intended to measure things like PSA levels (a protein in the blood linked to prostate health), time without disease progression, survival, and quality of life — no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03489057 · results posted 3 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03489057) involved cancer patients and their caregivers (called "partners" in the study). A total of 141 patients and 141 caregivers were enrolled in the PERC group (a structured support program), and 139 patients and 139 caregivers were enrolled in the usual care group. The trial tracked both groups over 12 months, measuring things like quality of life, pain, fatigue, sleep, anxiety, and depression using standardised questionnaires. Fewer participants completed the study than started — 106 in the PERC group and 115 in the usual care group finished all measurements. The reported data shows that for the main outcome — overall quality of life, scored on a scale of 0 to 108 where higher means better — both groups started at similar levels (around 89 points for PERC and 88 points for usual care) and remained broadly similar across all four time points over 12 months. For the secondary outcomes, the reported numbers were also close between the two groups throughout the study. Pain interference scores (where higher means more pain disrupting daily life) hovered around 48–50 for both groups at all time points. Fatigue-related scores sat around 46–49 for both groups. Sleep disturbance scores ranged roughly from 47 to 50 across both groups. Anxiety scores in the PERC group stayed around 44–45, while the usual care group ranged from about 46 to 49. Depression scores were very similar in both groups, staying close to 56–57 across all time points. The reported data shows scores that were relatively stable over the 12-month period in both groups, with no dramatic differences in the numbers between those who received PERC and those who received usual care — though interpreting what those numbers mean clinically is a matter for medical professionals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05249127 · results posted 1 October 2024
According to the results reported on ClinicalTrials.gov, this trial looked at an investigational PET scan imaging agent called 64Cu-SAR-bisPSMA, which is injected and then used to try to detect prostate cancer spread in the body. A total of 52 people were enrolled and started the trial, 32 completed it, and 20 did not finish. The trial measured how well the imaging agent detected disease (using scans taken on two different days — Day 0 and Day 1), as well as what unwanted effects occurred. The reported data shows that when scans were read by independent reviewers, the proportion of participants correctly identified as having detectable disease (called the "correct detection rate") ranged from about 19% to 26% on Day 0 scans, and from about 26% to 33% on Day 1 scans, depending on which reviewer assessed the images. A separate measure called "positive predictive value" — meaning the proportion of regions flagged as positive that were confirmed to be true positives — ranged from roughly 39% to 45% on Day 0 and from about 33% to 44% on Day 1. For the safety outcome, the reported data shows that 10 participants experienced some form of treatment-emergent adverse event (an unwanted effect occurring after the injection), of whom 8 were graded as mild (Grade 1), 2 as moderate (Grade 2), and 1 experienced a serious adverse event; no Grade 4 or Grade 5 events were reported. The reported data also shows measurements of how the imaging agent spread through the body, recorded as a value called SUVmean (a way of quantifying how much of the agent was taken up in different tissues). Across six types of body regions measured, Day 0 SUVmean values ranged from approximately 6.6 to 9.9, while Day 1 values were generally higher, ranging from approximately 10.5 to 19.4. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05181800 · results posted 27 September 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT05181800) followed 1,454 participants who were all receiving the medication FIRMAGON. All 1,454 participants who started the study also completed it. The trial was measuring how often participants experienced unwanted medical events — called adverse events — while receiving this treatment. These included both general unwanted medical occurrences and more serious ones, such as events that were life-threatening, required a hospital stay, caused lasting disability, or resulted in death. The reported data shows that 95% of participants experienced at least one adverse event (that is, any unwanted medical occurrence) during the study. Additionally, 63% of participants experienced at least one serious adverse event — meaning an unwanted medical occurrence that met specific criteria such as being life-threatening, requiring hospitalisation, or causing significant disability. No other outcome measures were included in the submitted results data beyond these two figures. It is important to note that an adverse event being recorded does not automatically mean it was caused by the medication — the definition used in this trial specifically states that a causal link does not have to be established. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03787680 · results posted 12 August 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 49 people in total across two groups. The first group, called "Cohort 1" (DRPro), included 37 participants whose cancer cells did not have certain DNA repair faults. The second group, called "Cohort 2" (DRDef), included 12 participants whose cancer cells did carry those DNA repair faults. The trial was measuring how often participants' cancer responded to the treatment — either fully (a "complete response") or partially (a "partial response") — judged by scans or by a drop in a prostate cancer blood marker (PSA) of 50% or more. Of the 49 people who started, 31 completed the study (26 in Cohort 1 and 5 in Cohort 2). The reported data shows that in Cohort 1 (the DNA repair proficient group), 11.4% of participants met the criteria for a complete or partial response. This means that out of the 37 people in that group, roughly 4 people showed this level of response as measured by scans or PSA levels. For the remaining outcome measures — including the response rate in Cohort 2 (the DNA repair deficient group), and how long participants in either group went without their disease progressing (known as "progression-free survival") — the reported data shows that no figures were submitted to ClinicalTrials.gov, so those results are not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04100018 · results posted 22 July 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04100018) enrolled 1,030 people in total — 514 in the group receiving nivolumab combined with docetaxel and prednisone, and 516 in the group receiving a placebo combined with docetaxel and prednisone. The trial was measuring two main things: how long participants went without their cancer showing signs of growing on scans (called radiographic progression-free survival), and how long participants lived overall. Several secondary measures were also tracked, including how many participants' tumours shrank, how quickly that happened, how long any shrinkage lasted, and whether a blood marker for prostate cancer called PSA dropped by at least half. The reported data shows that, for the main measure of time without cancer growth on scans, the nivolumab combination group had a reported median (the middle value in the data) of 9.43 months, compared with 8.74 months for the placebo combination group. For overall survival, the reported median was 18.73 months in the nivolumab group and 18.92 months in the placebo group. Regarding tumour shrinkage, 27.3% of participants in the nivolumab group and 23.5% in the placebo group were reported to have had their tumours shrink to a meaningful degree. The time until that shrinkage first appeared was approximately 2.17 months and 2.20 months respectively, and the reported duration of that shrinkage was 8.31 months versus 8.11 months. For the PSA blood marker, 42.4% of the nivolumab group and 41.6% of the placebo group were reported to have had a confirmed drop of 50% or more. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04564027 · results posted 25 June 2024
According to the results reported on ClinicalTrials.gov, this trial tested a drug called ceralasertib in two groups of cancer patients: one group had advanced solid tumours (Cohort A) and the other had a form of advanced prostate cancer (Cohort B). In total, 54 people were enrolled across both groups and two different doses (240 mg and 160 mg). The trial was measuring how often tumours responded to the treatment, how long any response lasted, and how tumour size changed over time. Notably, the reported data shows that the 240 mg dose was discontinued during the trial after a higher-than-expected number of participants on that dose experienced serious blood-related side effects early on, so the main results focus only on those who received the 160 mg dose. The reported data shows that among the 30 participants in Cohort A who received the 160 mg dose, about 7.1% had their tumour shrink enough to count as a meaningful response (meaning the tumour either disappeared completely or shrank by at least 30%). For Cohort B (prostate cancer), about 7.7% of the 15 participants on the 160 mg dose met a combined response measure, which included tumour shrinkage, a drop in a prostate-related blood marker, or a change in circulating tumour cell counts. The reported data also shows that in Cohort A, the average time before the disease progressed was 3.7 months. Individual changes in tumour size across both groups varied widely, ranging from increases to reductions as large as 100% in a small number of cases. The duration of response for Cohort A was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03458234 · results posted 20 May 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled five men with low or low-intermediate risk prostate cancer. All five began the study, four completed it, and one did not finish. The trial was testing a specific type of targeted radiation treatment for the prostate — called focal stereotactic body radiotherapy (SBRT) — delivered with the help of small tracking devices placed inside the urethra (the tube that carries urine out of the body). These tracking devices were intended to guide the radiation beam in real time, rather than using a traditional catheter approach. The reported data shows that, while the trial recorded four outcome measures — checking whether the treatment could be delivered as planned, looking at early signs of cancer control through a blood test called PSA, and assessing any side effects and quality of life beyond 90 days after treatment — no numerical results were submitted for any of these measures on ClinicalTrials.gov. The data for all primary and secondary outcomes was not reported, meaning it is not possible to describe what the measurements found. Because no outcome numbers were provided in the submitted results, it is not known from this record what the trial found regarding treatment delivery, cancer markers, side effects, or quality of life for the participants involved. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04086966 · results posted 26 April 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people with metastatic prostate cancer, and all 10 completed the study. The trial was looking at whether a specialised scanning technique — called PSMA-PET/MRI, which combines two types of imaging to look for cancer spread — could find cancer in the lymph nodes of the pelvis that a standard MRI scan on its own might miss. It also looked at whether a higher-than-usual dose of targeted radiotherapy could be practically delivered based on what the combined scan showed. The reported data shows that in 3 out of the 10 participants, the PSMA-PET/MRI scan picked up cancer in pelvic lymph nodes that had not been detected by MRI alone. In total, the combined scan identified 19 affected lymph nodes across the group, compared with 9 lymph nodes detected by MRI on its own. The reported data also shows that for 8 of the 10 participants, it was considered feasible to deliver the higher-dose radiotherapy based on the scan findings. For one of the secondary measures — tracking serious bowel or urinary side effects (rated Grade 3–5 on a standard medical scale, meaning moderate-to-severe) — the reported data shows that 0 participants experienced side effects at that level. It is important to note that with only 10 participants, this is a very small study, and the numbers should be interpreted with that in mind. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05407714 · results posted 22 February 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT05407714) involved 15 participants, all assigned to the SpaceOAR treatment arm. The trial was measuring two main things: first, the physical gap created between the prostate and the rectum after a gel spacer was inserted; and second, how many participants experienced unwanted medical events (known as adverse events) linked to the SpaceOAR device or the procedure within 30 days. A secondary measurement looked at how many participants had a result considered a "functional success" in terms of that same gap between the prostate and rectum. The reported data shows that, on average, the measured distance between the back of the prostate and the front of the rectum was 15.1 millimetres. Regarding the safety endpoint, 2 out of 15 participants were reported to have experienced adverse events considered related to the SpaceOAR system or procedure within the 30-day observation window. It is worth noting that valid data was available for 14 of the 15 participants for analysis purposes. For the secondary outcome, the reported data shows that 14 participants were recorded as achieving a "functional success" result for the gap measurement — though the specific threshold used to define that term was not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03388346 · results posted 15 February 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 22 participants, all of whom completed the study. The trial looked at how well a type of specialised scan — called a Gallium-68 PSMA PET/CT scan — could detect whether prostate cancer had spread to nearby lymph nodes in the pelvis, or to lymph nodes further away in the body. The scan works by using a small amount of a radioactive substance that attaches to a protein commonly found on prostate cancer cells, making those areas visible on the scan. Participants then had surgery to remove lymph nodes, and the scan results were compared against what was actually found in the tissue under a microscope. The reported data shows four key numbers for detecting cancer spread within the pelvis. "Sensitivity" — meaning how often the scan correctly spotted nodes that did turn out to have cancer — was reported as 0.50, or 50 in 100 patients. "Specificity" — how often the scan correctly gave the all-clear for nodes that truly were cancer-free — was reported as 0.89, or about 89 in 100 patients. The "positive predictive value" (how often a positive scan result matched a positive tissue result) was reported as 0.33, or about 33 in 100 positive scan results. The "negative predictive value" (how often a negative scan result matched a negative tissue result) was reported as 0.94, or about 94 in 100 negative scan results. For lymph nodes outside the pelvis, the reported data shows a sensitivity of 0 and a specificity of 0.71. The trial authors did not report additional figures beyond these for the out-of-pelvis measurements. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03577028 · results posted 14 February 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03577028) enrolled 104 people in total with a form of advanced prostate cancer that had spread to other parts of the body and was no longer responding to hormone-lowering treatment. Participants were split across six different dosing groups, testing a drug called HPN424 given either by drip into a vein (intravenous, or IV) or by injection under the skin (subcutaneous, or SC), at various dose levels and schedules. The main thing the trial was measuring was the number and seriousness of "dose-limiting toxicities" — that is, side effects severe enough to set a ceiling on how much of the drug could be given. The trial was ended earlier than originally planned, so instead of reporting results for each individual dose level, the final analysis compared the different dosing schedules overall. The reported data shows that across all groups, all 104 participants who started the study also completed it — none withdrew before the end. When it came to dose-limiting toxicities, the largest group (Fixed IV, 64 participants) reported 6 such events. The two "1 Prime Step IV" groups reported 0 and 4 events respectively across 6 and 12 participants. The two "2 Prime Step IV" groups reported 2 and 3 events across 10 and 9 participants respectively. The smallest group (Fixed SC, 3 participants) reported 1 such event. No secondary outcome measure data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04220983 · results posted 6 February 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 22 men with prostate cancer, and all 22 completed the study — none dropped out. The trial was testing a type of targeted radiation treatment called MR-guided prostate SBRT (a precise form of radiotherapy guided by MRI scanning). The main thing the trial was measuring was the number of participants who experienced side effects (called adverse events), particularly severe bowel or urinary side effects in the first 30 days after treatment. It also measured participants' quality of life and urinary symptoms over time. The reported data shows that 22 participants were assessed for adverse events overall, with 18 and then 17 participants recorded at different follow-up points — though the exact timing of each count was not clearly broken down in the submitted data. For quality of life, the trial used a questionnaire called EPIC, where scores run from 0 to 100 and higher scores indicate better outcomes. The reported data shows a range of scores across different areas (such as urinary, bowel, sexual, and hormonal function) at different time points, with values spanning from approximately 4.7 to 96.8 across all categories and time points — however, the submitted data does not clearly label which score belongs to which domain or time point, so a precise breakdown cannot be provided here. For urinary symptoms, a separate questionnaire (scored 0–35, where higher scores mean more symptoms) recorded average scores of 10.7 at baseline, 9.0 at a mid-point, and 12.2 at a later follow-up. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03698370 · results posted 30 January 2024
According to the results reported on ClinicalTrials.gov, this trial involved 27 men with prostate cancer who each received two different types of specialised body scans — one using a scanning agent called Ga68-NeoBOMB1 and one using an agent called Ga68 PSMA-R2. The trial was a crossover design, meaning participants received both scans but in different orders: 13 people had the Ga68-NeoBOMB1 scan first, and 14 had the Ga68 PSMA-R2 scan first. All 27 participants completed both scans. The trial was measuring how many suspicious spots (lesions) each type of scan picked up, and how many of those spots were later confirmed to be cancerous. The reported data shows that when looking at the primary question — how many lesions each scan detected — the Ga68-NeoBOMB1 scan identified 31 lesions in total, while the Ga68 PSMA-R2 scan identified 20 lesions. For the secondary question — how many of those detected lesions were later confirmed as cancerous through biopsy or follow-up scans over 12 months — the reported data shows 18 confirmed malignant lesions for Ga68-NeoBOMB1 and 15 for Ga68 PSMA-R2. These numbers reflect what was detected and subsequently confirmed across all participants combined. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04887506 · results posted 16 January 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 107 people in total — 54 in the TAVT-45 group and 53 in the comparison group receiving a reference version of abiraterone acetate (a medicine called Zytiga®). The trial was measuring levels of a hormone called testosterone in the blood, to compare what happened to testosterone levels in people taking TAVT-45 versus those taking the reference medicine. Testosterone levels in the blood were the main thing being tracked, along with a marker called PSA (prostate-specific antigen), which is a substance measured in the blood that is commonly monitored in prostate cancer care. The reported data shows that, for the main measurement — average blood testosterone levels on Days 9 and 10 of treatment — both groups recorded a reported value of 1.0 ng/dL (nanograms per decilitre, a unit for measuring very small amounts of a substance in blood). In supplementary analyses looking at slightly different groupings of participants, the reported testosterone values were also very similar between the two groups: around 1.01 ng/dL for TAVT-45 and 1.04 ng/dL for the reference medicine in one grouping, and approximately 1.00 ng/dL versus 1.01 ng/dL in another. For the PSA measurement — which tracked how many participants had a drop of 50% or more in their PSA levels from the start of the trial — the reported data shows 47 participants in the TAVT-45 group and 39 participants in the reference medicine group reached that threshold, though the total numbers in each group at that stage of analysis were not fully detailed in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04076059 · results posted 18 November 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04076059) enrolled 180 participants in its main double-blind phase — 120 people received enzalutamide plus androgen deprivation therapy (ADT, a standard hormone treatment that lowers testosterone), and 60 received a placebo (dummy pill) plus ADT. A further 23 participants took part in a separate open-label phase where everyone received enzalutamide plus ADT. The trial was primarily measuring how long it took for a protein in the blood called PSA (prostate-specific antigen) to start rising again — a sign that the cancer may be progressing — and also tracked a number of secondary outcomes including cancer spread on scans, bone complications, and how much PSA levels dropped. The reported data shows that for the primary outcome — time to PSA progression — a result was only reported for the placebo-plus-ADT group, where the median time was 9.2 months. A median figure means half the participants in that group reached this point before 9.2 months and half after. The corresponding figure for the enzalutamide-plus-ADT group was listed as "NA" (not available/not reached), meaning the data was not reported or the endpoint had not been reached in enough participants to calculate it at the time of reporting. For the secondary outcomes, the placebo group's median time before cancer showed signs of spreading on scans was reported as 19.4 months, and the median time before castration resistance (when the cancer stops responding to hormone-lowering treatment) was 8.3 months; again, the enzalutamide group figures were not reported. For bone complications, neither group's figure was reported. Regarding PSA reductions, the reported data shows that 93.3% of the enzalutamide group had their PSA drop by at least 50%, compared with 80.0% in the placebo group; and 86.7% of the enzalutamide group had their PSA drop by at least 90%, compared with 55.0% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04737109 · results posted 13 November 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04737109) was studying a combination of three treatments — ipatasertib, darolutamide, and androgen deprivation therapy (ADT, a standard hormone treatment for prostate cancer) — in men with high-risk, localised prostate cancer. The trial was designed in two parts: a Phase I part to find a safe starting dose, and a Phase II part to measure how well the combination worked before surgery. In total, only 6 participants were enrolled, all in the Phase I dose-finding group. None of the other planned groups — including the main Phase II group — appear to have enrolled any participants based on the data submitted. The reported data shows that in the Phase I group, zero dose-limiting toxicities (that is, serious side effects severe enough to require stopping or reducing the dose) were recorded during the first 28 days of treatment. All three outcome measures planned for the Phase II group — including the main measure of whether the cancer had completely disappeared at surgery, a measure of PSA levels becoming undetectable after testosterone recovered, and a two-year measure of whether PSA stayed low — have no numbers reported. This is because, based on the submitted data, the Phase II part of the trial does not appear to have been completed or fully enrolled. The reported data shows this trial was largely incomplete, with only a very small number of participants in the early dose-finding phase and no results available for the main Phase II questions the trial set out to answer. Where data was not reported for an outcome, it has not been included here, as no figures were available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03840200 · results posted 30 October 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 51 people in total across four groups: 8 in Dose Escalation Cohort 1, 6 in Dose Escalation Cohort 2a, 7 in Dose Escalation Cohort 2b, and 30 in the Dose Expansion group. The trial was testing a combination of two medicines — ipatasertib and rucaparib — in people with prostate cancer. It was primarily measuring unwanted medical events (called adverse events) that participants experienced, serious side effects that set a ceiling on how high the dose could go (called dose-limiting toxicities), and whether participants' PSA levels — a protein in the blood often tracked in prostate cancer — dropped by at least half. The reported data shows that every participant across all four groups (100%) experienced at least one adverse event. Regarding serious dose-limiting side effects, the reported figures were 12.5% of participants in Cohort 1, 33.3% in Cohort 2a, and 0% in Cohort 2b. For the PSA measure — a drop of 50% or more — the reported data shows 0% of Cohort 1 participants met this threshold, compared with 33.3% in Cohort 2a, 25.0% in Cohort 2b, and 23.1% in the Dose Expansion group. On a separate measure looking at tumour shrinkage based on scans, the reported rate of participants whose tumours shrank meaningfully was 0% in each of the three dose-escalation cohorts and 13.3% in the Dose Expansion group. The reported data shows that the time until the disease progressed or participants died (called radiographic progression-free survival) had a middle value of 11.0 months in Cohort 1, 3.0 months in Cohort 2a, 5.1 months in Cohort 2b, and 7.2 months in the Dose Expansion group. The duration of response figure for the Dose Expansion group was not reported in the submitted data. Notably, none of the 51 participants were recorded as having completed the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03649841 · results posted 26 October 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03649841) enrolled a total of 10 men with prostate cancer. Six participants were placed in Arm I, receiving hormone therapy (ADT) combined with abiraterone and prednisone (a steroid), while four participants were in Arm II, receiving the same combination plus radiation therapy. The trial was primarily looking at changes in a type of immune cell in the blood — called effector T-cells — to see whether levels changed differently between the two groups after treatment began. The reported data shows that no measurements were recorded for the primary outcome (the change in effector T-cells), meaning those results were not reported in the data submitted to ClinicalTrials.gov. For one of the secondary outcomes — the number of participants whose PSA (a prostate-related protein measured in the blood) dropped to an undetectable level at six months — the reported data shows one participant in each arm reached that level. Regarding adverse events (unwanted or unexpected health changes during the trial), the reported data shows that two participants in Arm I experienced side effects graded as serious (grade 3 or higher on a standard medical scale), while no participants in Arm II were reported as having side effects at that level of severity. It is worth noting that with only 10 participants in total, these numbers are very small and should be interpreted with great caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02975934 · results posted 16 August 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02975934) enrolled 405 people in total across its two phases. In the main treatment phase, 270 participants received rucaparib and 135 received one of three comparison treatments (abiraterone acetate, enzalutamide, or docetaxel). A further 70 participants from the comparison group later crossed over to receive rucaparib in a separate phase. All participants had prostate cancer with specific gene changes (called BRCA or ATM alterations). The trial was primarily measuring how long participants went without their cancer visibly progressing on scans — a timeframe known as "radiographic progression-free survival." The reported data shows that, among participants with a BRCA gene alteration, the median time before cancer showed visible progression on scans (or death occurred) was 11.2 months in the rucaparib group compared with 6.4 months in the comparison treatment group. When looking at participants with either a BRCA or ATM gene alteration combined, the reported median figures were 10.2 months for rucaparib and 6.4 months for the comparison group. For overall survival (the time from the start of the trial until death from any cause), the reported data shows median figures of 23.2 months (rucaparib) versus 21.2 months (comparison) in the BRCA-alteration group, and 22.8 months versus 21.7 months in the combined BRCA/ATM group. The trial also measured how many participants with measurable tumours had their tumours shrink — in the BRCA group, 37 participants in the rucaparib group and 7 in the comparison group had a recorded tumour shrinkage response. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00859781 · results posted 19 July 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 55 men with prostate cancer across two groups. Thirty-eight participants received a treatment called 177Lu-J591 combined with ketoconazole, and 17 received 111In-J591 combined with ketoconazole. All 55 participants who started the trial completed it. The trial was primarily looking at how many participants showed no sign of cancer spread (metastases) on medical imaging scans — such as CT, MRI, or bone scans — from the start of the study through to 18 months after receiving the study drug. The reported data shows that in the 177Lu-J591 plus ketoconazole group, half of participants (a proportion of 0.50, meaning 50 in every 100) had no radiographically evident metastases at the 18-month point. In the 111In-J591 plus ketoconazole group, the reported proportion was 0.24 (meaning about 24 in every 100 participants). The trial also planned to measure changes in PSA levels — a protein in the blood often monitored in prostate cancer — as a secondary outcome, however the reported data shows that no numerical results for this measure were submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03732820 · results posted 15 June 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03732820) enrolled 796 men with prostate cancer — 399 received a combination of olaparib (300 mg twice daily) and abiraterone (1000 mg once daily), while 397 received a placebo alongside abiraterone. The trial was measuring things like how long it took for the cancer to show signs of growing on scans (called radiological progression-free survival), how long participants lived overall, how long before they needed a new cancer treatment, changes in pain levels, use of strong pain medicines (opiates), and whether participants experienced serious bone-related complications. It is worth noting that the data shows zero participants were recorded as having "completed" the study in the formal sense — all participants were counted under "not completed," which is common in long-running cancer trials where the study ends before all events are observed. The reported data shows that for the primary measure — the number of people whose cancer showed signs of growing on scans or who died — 168 out of 399 people in the olaparib plus abiraterone group experienced this event, compared with 226 out of 397 in the placebo plus abiraterone group. For overall survival (deaths from any cause), 176 people in the olaparib combination group and 205 in the placebo group died during the study period. Regarding the move to a new cancer treatment or death, 255 participants in the olaparib group and 285 in the placebo group reached that point. The reported data also shows that for worsening pain, 68 people in the olaparib group and 60 in the placebo group experienced a pain progression event; for first-time opiate use for cancer-related pain, the numbers were 58 and 45 respectively; and for serious bone-related events (such as fractures or needing radiation to the bones), 46 people in the olaparib group and 51 in the placebo group were affected. These are raw counts of how many people experienced each event — the trial results as submitted do not include the timing or statistical comparison figures in this dataset. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00106691 · results posted 12 June 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 802 men in the placebo group and 787 men taking a daily 20 mg dose of toremifene. All participants had been found to have a condition called high-grade prostatic intraepithelial neoplasia (PIN) — abnormal cells in the prostate that doctors sometimes monitor because of a possible link to prostate cancer. The trial was measuring whether toremifene could reduce the chance of those men being later diagnosed with prostate cancer, and it also tracked changes in blood lipid levels (fats in the blood such as cholesterol), hormone levels, a prostate protein called PSA, and urinary symptoms. Around 598 men in the placebo group and 588 in the toremifene group completed the study. The reported data shows that at 36 months, approximately 54.9% of men in the placebo group and 59.5% of men in the toremifene group remained free of a prostate cancer diagnosis based on biopsy. A separate primary measure looked at the average time until a positive cancer biopsy occurred — this was reported as 23.5 months for the placebo group and 15.9 months for the toremifene group. For the secondary outcomes, the reported data shows changes in blood fats from the start of the trial: total cholesterol changed by about −3.7% (placebo) and −6.7% (toremifene); LDL cholesterol by −7.4% and −7.8%; HDL cholesterol by +3.7% and +0.3%; and triglycerides by +16.3% and +0.3%. Hormone level changes from baseline were also recorded — for example, total testosterone changed by about +17.7% (placebo) versus +46.4% (toremifene), and estradiol by +17.7% versus +7.9%. PSA levels changed by 0.82 mcg/L in the placebo group and 1.07 mcg/L in the toremifene group. Urinary symptom scores (on a scale of 0–35, where higher means worse) changed by an average of 1.1 points in the placebo group and 1.2 points in the toremifene group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03113617 · results posted 24 May 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 44 people, all of whom completed the study. The trial was looking at a type of scan called a 68Ga-RM2 PET/CT scan — a specialised imaging technique that uses a small amount of a radioactive tracer to try to detect whether prostate cancer had spread to nearby lymph nodes. The results from the scan were compared against tissue samples taken during surgery (radical prostatectomy) to see how well the scan matched what was actually found. The reported data shows that, for the 68Ga-RM2 PET/CT scan, the sensitivity (meaning the percentage of cases where the scan correctly identified lymph nodes that turned out to contain cancer) was reported at 55.6%. The specificity (the percentage of cases where the scan correctly identified lymph nodes that turned out to be cancer-free) was reported at 92.3%. The positive predictive value — roughly, how often a positive scan result matched a true cancer finding — was reported at 71.4%, and the negative predictive value — how often a negative scan result matched a truly cancer-free finding — was reported at 85.7%. The reported data also shows how the 68Ga-RM2 PET/CT scan compared to standard cross-sectional imaging (such as CT or MRI) done at the same time: that standard imaging showed a sensitivity of 22.2%, specificity of 96.2%, a positive predictive value of 66.7%, and a negative predictive value of 78.1%. Several other planned measurements, including findings about bone and distant spread, scan uptake levels, and longer-term cancer progression, were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00643994 · results posted 9 May 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 310 people with prostate cancer, all of whom received a type of targeted radiation treatment called CyberKnife Stereotactic Radiosurgery. Of those, 214 were recorded as having completed the study, and 69 reached the 10-year follow-up point. The trial was measuring two main things: how often patients experienced serious side effects affecting the bowel or urinary system (graded as severe, life-threatening, or fatal), and how many patients remained free of signs of returning cancer based on a blood marker called PSA (a protein produced by the prostate). The reported data shows that, for serious bowel and urinary side effects (rated Grade 3 or higher on a standard medical scale), the reported rate was 0% for acute side effects in both categories, and 1.5% for late-occurring serious bowel side effects and 1.5% for late-occurring serious urinary side effects. For cancer-related outcomes, the reported data shows that 97.3% of participants showed no sign of cancer return at 5 years based on PSA levels, dropping to 91.7% at 10 years. Secondary outcome figures — covering local spread, distant spread, disease-free survival, disease-specific survival, and overall survival — ranged from around 83.8% to 100% across the 5- and 10-year time points, though the data as submitted does not label which specific percentage corresponds to which individual outcome category. The reported data also shows quality-of-life scores were collected at multiple time points using standard questionnaires measuring urinary and bowel symptoms. On the urinary symptom score (rated 0–35, where higher means worse symptoms), scores appeared to rise from a starting average of around 7.6 before returning toward similar or lower levels over time. On the quality-of-life questionnaires (scored 0–100, where higher means fewer problems), scores across urinary categories generally remained in the mid-to-high 80s and 90s throughout the follow-up period, though the data does not specify the exact time point for each individual number reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03429244 · results posted 8 May 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people across three groups: 16 who were having their prostate removed (radical prostatectomy), 11 who were being screened for prostate cancer or were on active surveillance (a monitoring approach), and 9 who were receiving focal therapy (a targeted treatment aimed at a specific area of the prostate). The trial was looking at whether a type of specialised scan called a PSMA PET scan — which uses a radioactive tracer to highlight prostate cancer cells — could accurately detect whether the cancer had spread beyond the prostate, and whether the scan changed how doctors planned treatment or follow-up procedures. Not everyone completed the trial: 14, 10, and 8 participants finished in each of the three groups respectively. The reported data shows two main sets of results. For the primary measure — how accurately the PSMA PET scan detected cancer that had spread beyond the prostate — the results were reported only for the surgical group. The scan correctly identified all cases where the cancer had spread (reported as 100% sensitivity, meaning it did not miss any confirmed cases), and correctly identified 74% of cases where the cancer had not spread (reported as 74% specificity, meaning it correctly ruled out spread in about three-quarters of those cases). For the secondary measure — whether the scan led doctors to change their treatment or follow-up plan — the reported data shows that the plan was altered for 10 out of 16 participants in the surgical group, 8 out of 11 in the screening/active surveillance group, and 5 out of 9 in the focal therapy group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02985957 · results posted 24 April 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02985957) enrolled a total of 351 participants across several groups, all of whom had prostate cancer. The trial tested different combinations of two immunotherapy medicines — nivolumab and ipilimumab — given at varying doses and schedules, and compared them against each other and against a chemotherapy option (cabazitaxel plus prednisone). The trial was measuring two main things: how many participants' tumours shrank or disappeared (called the "objective response rate"), and how long participants went without their cancer visibly growing or spreading on scans — known as "radiographic progression-free survival." The reported data shows that, for the groups receiving nivolumab plus ipilimumab in the earlier part of the trial (Cohorts B and C), the percentage of participants whose tumours shrank or disappeared was 12.5% and 20.0% respectively. The median time those same groups went without their cancer visibly progressing on scans was reported as approximately 7.6 months and 5.4 months. In the later, randomised part of the trial (Cohort D), the reported tumour-shrinkage rates were 8.9%, 15.2%, 4.3%, and 11.1% across the four arms. The median time without visible cancer progression on scans for those four arms was reported as approximately 3.9, 4.2, 3.5, and 7.9 months respectively — with the chemotherapy arm (cabazitaxel plus prednisone) recording the longest figure of the four. The reported data also shows a secondary measure — how long participants went without their cancer progressing either on scans *or* by clinical signs. For Cohorts B and C, these figures were approximately 4.3 and 3.7 months. For the four arms of Cohort D, the figures were approximately 2.5, 3.8, 2.7, and 5.9 months respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03834519 · results posted 20 April 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03834519) enrolled 793 people with prostate cancer across two groups: 529 people received a combination of pembrolizumab and olaparib (two cancer medicines), and 264 people received a single hormonal medicine (called a next-generation hormonal agent, or NHA). The trial was primarily measuring two things: how long participants lived overall (called overall survival), and how long it took before scans showed the cancer had visibly grown or spread (called radiographic progression-free survival). The reported data shows that for overall survival, participants in the combination group had a median of 15.8 months, compared with 14.6 months in the single-medicine group. ("Median" here means the midpoint — half the participants in each group lived longer than that figure, half did not reach it.) For the scan-based measure of cancer progression, the reported median was 4.4 months in the combination group and 4.2 months in the single-medicine group. Among secondary measures, the reported data shows that 16.8% of participants in the combination group had their tumours shrink or disappear on scans, compared with 5.9% in the single-medicine group. For those whose tumours did respond, the reported duration of that response was 8.1 months in the combination group and 8.5 months in the single-medicine group. The time before participants started a new cancer treatment after the study was a median of 7.2 months in the combination group and 5.7 months in the single-medicine group. Time to a rising PSA (a prostate-specific blood marker) was reported as 3.3 months and 3.5 months respectively. No participants were recorded as having formally "completed" the trial, and the data does not explain why — that detail was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03072238 · results posted 10 April 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03072238) enrolled 1,101 participants in total — 554 in the placebo plus abiraterone group (referred to as "Pbo + Abi") and 547 in the ipatasertib plus abiraterone group ("Ipat + Abi"). The trial was measuring outcomes in men with prostate cancer, looking at two groups of participants: everyone in the trial (called the "ITT population") and a subgroup who had a specific genetic tumour characteristic called PTEN loss. The main thing being measured was how long participants went without their cancer visibly progressing on scans or dying — a measure called radiographic progression-free survival (rPFS), which is simply the time from joining the trial until the cancer showed clear signs of worsening on imaging, or until death, whichever came first. The reported data shows that, for the subgroup with PTEN loss, the median rPFS (that is, the point in time by which half the participants had experienced progression or death) was 16.5 months in the Pbo + Abi group and 18.5 months in the Ipat + Abi group. Across all participants in the trial, the median rPFS was 16.6 months for Pbo + Abi and 19.2 months for Ipat + Abi. For overall survival (how long participants lived from the start of the trial), the reported median figures in the PTEN-loss subgroup were 35.8 months for Pbo + Abi and 36.8 months for Ipat + Abi; across all participants, those figures were 36.5 months and 39.4 months respectively. The reported data also shows that the median time until cancer-related pain worsened was 17.6 months (Pbo + Abi) versus 25.8 months (Ipat + Abi) in the PTEN-loss subgroup, and 21.9 months versus 25.9 months across all participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01385059 · results posted 7 March 2023
According to the results reported on ClinicalTrials.gov, this trial involved 11 people in total — 4 in a group who received a drug called axitinib (an enzyme inhibitor) before surgery to remove the prostate, and 7 in a group who had surgery alone. The trial was measuring something called "pre-metastatic niche density" in the lymph nodes — essentially, the average number of clusters of a particular protein (called VEGFR1) seen under a microscope in tissue samples taken from nearby lymph nodes. The idea behind measuring this was to compare the two groups and see whether the numbers differed. The reported data shows that the group who received axitinib before surgery had an average of 75.6 protein clusters per microscopic field in their lymph node samples, while the group who had surgery alone had an average of 62.5 clusters per microscopic field. No secondary outcome measures appear to have been reported in the data submitted to ClinicalTrials.gov for this trial. It is worth noting that only 11 people took part in this trial, which is a very small number, and the results submitted do not include any further context about what these figures mean clinically. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02799602 · results posted 24 February 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,305 people with prostate cancer — 651 in the group receiving darolutamide plus docetaxel (a type of chemotherapy), and 654 in the group receiving a placebo plus docetaxel. The trial was measuring overall survival (how long people lived from the point they joined the study), as well as a number of secondary outcomes including how long it took for the cancer to become "castration-resistant" (meaning it continued to grow despite hormone-lowering treatment), how long before participants experienced worsening pain, and how many participants had unwanted medical events (called adverse events) during treatment. The reported data shows that, for the primary measure of overall survival, 229 deaths occurred in the darolutamide group and 304 deaths occurred in the placebo group during the study period; the remaining participants (422 and 350 respectively) were still alive or had not yet reached that point when the data was recorded. For the secondary measure of time to cancer becoming castration-resistant, the placebo group reached a midpoint figure (meaning half the group had reached that stage) at 19.1 months, while a equivalent figure for the darolutamide group could not be calculated from the available data. Similarly, for time to pain worsening, the midpoint figure for the placebo group was 27.5 months, while the equivalent figure for the darolutamide group was not able to be estimated from the data. Regarding adverse events (unwanted medical events during treatment), the reported data shows these were recorded in 649 of 651 participants in the darolutamide group and 643 of 651 participants in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04424641 · results posted 1 February 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04424641) enrolled a total of 37 people across eight groups, each receiving a different dosing schedule of an investigational drug called GEN1044. The trial was an early-phase study primarily designed to look at how the body tolerates different dose levels of GEN1044, and to find out whether any doses caused serious problems significant enough to limit how much could be given (called "dose-limiting toxicities"). It also tracked general side effects, unusual blood test results, how tumours responded to treatment, and whether the body developed antibodies against the drug itself. The reported data shows that when it came to dose-limiting toxicities, none were recorded in the four lowest-dose groups. In the higher-dose groups, one participant in one group and three participants each in two other groups experienced these events; no data was reported for one group (GEN1044 Doses 1/5/37.5 mg) for this particular measure. For general side effects that emerged during treatment, the reported data shows at least one such event occurred in every participant across all eight groups — totalling all 37 people. Serious side effects were reported in participants across several groups, with numbers ranging from one to five per group where data was provided; figures for some groups were not reported. Regarding abnormal blood test results at a significant level, between zero and seven participants per group were recorded, depending on the dose. For tumour response, the reported data shows that no participant in any group achieved either a complete disappearance of tumours or a reduction of at least 30% in tumour size. Finally, regarding antibodies that the body may develop against the drug, between zero and three participants per group were recorded as testing positive after starting treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03111914 · results posted 20 January 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 7 participants, all of whom received a type of specialised CT scan called Dual Energy Computed Tomography (DECT). The trial was looking at whether this scanning approach could be used to monitor bone disease that had spread from prostate cancer — specifically, whether it could tell the difference between the cancer responding to treatment and the cancer getting worse. None of the 7 participants were recorded as having completed the study, and all 7 were listed as "not completed." The reported data shows that no numerical results were submitted for any of the trial's primary outcome measures. These outcomes were intended to assess things like how accurately the scan could detect changes in bone disease, and how reliably different readers (the people interpreting the scans) could use the images to distinguish between a response to treatment and disease progression. However, the actual figures for all of these measures — including accuracy, sensitivity (how well the test picks up true cases), and specificity (how well it rules out non-cases) — were not reported in the data submitted to ClinicalTrials.gov. Because no participants completed the study and no outcome numbers were provided, it is not possible to draw any conclusions from this trial about the scanning approach being tested. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02643303 · results posted 2 December 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT02643303) enrolled a total of 56 people across nine different groups. It was a Phase 1/Phase 2 study involving adults with various advanced cancers, including head and neck cancer, breast cancer, sarcoma, Merkel cell carcinoma, melanoma, genitourinary cancers, and other solid tumours. The trial was measuring two main things: how many participants experienced side effects that arose during treatment, and how participants' tumours responded to the study treatment. Tumour responses were tracked using standard imaging-based scoring systems. The reported data shows that when it came to side effects (called "treatment-emergent adverse events"), every participant in each group who started the study was recorded as having experienced at least one. For tumour response, the results were largely limited: using one scoring method (irRECIST), only 1 participant — in the earliest Phase 1 group (Cohort 1A, which had 4 people) — was reported to have had a partial response (meaning their tumour shrank by at least 30%). No complete responses (full disappearance of tumours) were reported in any group. For disease control — meaning tumours either shrank or stayed stable for a meaningful period — 1 participant in Cohort 1A and 3 in the breast cancer group met that measure, with no participants in the other groups doing so. For how long participants went without their disease getting worse (called "progression-free survival"), the reported middle-point figures ranged from 43 days in the genitourinary cancer group to 157 days in Cohort 1A. These figures were broadly similar whether measured by the irRECIST or RECIST 1.1 scoring methods. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03406858 · results posted 15 November 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants, all of whom received a combination treatment involving two investigational therapies: pembrolizumab (an immunotherapy drug) and HER2Bi-armed activated T cells (a type of immune cell therapy prepared in a laboratory). Thirteen participants completed the study, while two did not finish. The trial was measuring how many participants went a set period of time without their disease getting worse — specifically looking at what is called "progression-free survival" at six months, meaning the proportion of people whose condition had not progressed six months after joining the study. The reported data shows that 38.5% of participants — roughly four out of every ten people in the study — had not experienced disease progression at the six-month mark. No other outcome measure results were included in the data submitted to ClinicalTrials.gov, so additional figures are not available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03693612 · results posted 22 August 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03693612) enrolled 26 participants in total across Part 1 — the only part of the trial for which results data was submitted. The trial was testing different dose combinations of two investigational medicines, feladilimab and tremelimumab, in people with cancer. Part 1 was a dose-finding phase, where small groups of participants received different amounts of each drug to observe what happened. Part 2 of the trial (which would have compared the combination against standard of care) reported zero participants started, meaning that phase did not appear to run. The reported data shows that the primary focus of Part 1 was counting how many participants experienced certain medically significant events. A "dose-limiting toxicity" (DLT) — meaning a harmful reaction serious enough within the first 28 days to limit how much of the drug could be given — was reported in 1 out of 16 participants in the highest-dose combination group (feladilimab 24 mg + tremelimumab 225 mg), and zero participants in all other dose groups. When looking at general adverse events (unexpected medical occurrences during the trial), all 26 participants across the five groups experienced at least one such event. Serious adverse events — those requiring hospitalisation or considered life-threatening — were reported in 12 participants across the groups, with the highest number (6 out of 16) in the largest dose group. Some participants also had their doses delayed or modified due to these events, with 3 participants affected in the feladilimab 8 mg + tremelimumab 225 mg group and 4 in the feladilimab 24 mg + tremelimumab 225 mg group. Numbers for some severity sub-categories were not fully reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03964337 · results posted 29 June 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03964337) was designed to compare two groups of prostate cancer patients: one group who received a drug called cabozantinib before having their prostate surgically removed, and another group who went straight to surgery without the drug first. The trial aimed to measure changes in tumour tissue and immune cells in the blood and tumour — including a marker of cell death (called the apoptotic index), as well as various types of immune cells such as suppressor cells, neutrophils, and different types of macrophages. Only 3 people were enrolled into the cabozantinib-then-surgery group (Arm A), and no participants were enrolled into the immediate surgery group (Arm B). All 3 participants who started the trial completed it. The reported data shows that, despite the trial being completed by its participants, no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — neither the primary measure (the cell death marker in tumour tissue) nor any of the secondary measures (the various immune cell percentages in blood and tumour tissue). Because no figures were provided in the results data, it is not possible to describe what the measurements showed. It is worth noting that with only 3 participants enrolled in one arm and none in the other, this trial was far smaller than originally intended, which is likely why meaningful comparisons between the two groups could not be made. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03473925 · results posted 29 June 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03473925) tested two different doses of a drug called navarixin — 30 mg or 100 mg — each given in combination with another drug called pembrolizumab (200 mg). A total of 107 people joined the trial (52 in the lower-dose group and 55 in the higher-dose group), and it enrolled people with certain types of advanced cancer, including bowel cancer, prostate cancer, and lung cancer. The trial was measuring how many participants' tumours shrank or disappeared, how long it took for the disease to progress, and what unwanted medical events occurred during treatment. Notably, no participants were recorded as having completed the study — all either left early or the study ended before completion. The reported data shows that the proportion of participants whose tumours shrank significantly (known as the "objective response rate") was low in both groups: approximately 3.9% in the 30 mg group and 1.9% in the 100 mg group. When a different set of measurement rules designed for immune-based treatments was applied, the reported response rate was 0% in both groups among those whose disease had already progressed. For how long participants went without their disease getting worse (called "progression-free survival"), the reported median figures ranged from about 1.8 to 2.4 months across the different cancer types in the 30 mg group, and around 1.9 to 2.1 months in the 100 mg group. Regarding unwanted medical events, the reported data shows that 50 out of 51 treated participants in the lower-dose group and 54 out of 54 in the higher-dose group experienced at least one adverse event. A smaller number stopped treatment because of an adverse event — 4 people in the 30 mg group and 6 in the 100 mg group. Serious dose-limiting events in the first treatment cycle were recorded for 2 participants in the 30 mg group and 3 in the 100 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02952534 · results posted 8 June 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 277 people in total with prostate cancer that had spread. Participants were grouped by the type of gene mutation they carried: 172 had a BRCA mutation, 59 had an ATM mutation, 14 had a CDK12 mutation, 7 had a CHEK2 mutation, and 25 had another gene mutation. The trial was measuring how often tumours shrank or disappeared (called an "objective response") in people with measurable disease, as well as how long those responses lasted and whether a blood marker for prostate cancer — called PSA — dropped significantly. The reported data shows that, looking at tumour scans reviewed by an independent panel, 45.7% of participants in the BRCA mutation group and 41.2% in the "other gene mutation" group had their tumours shrink or disappear to a qualifying degree. In the ATM, CDK12, and CHEK2 mutation groups, the reported figure was 0.0% by that same independent review. When the treating doctors did their own assessments, the reported figures were 48.3% (BRCA), 9.5% (ATM), 0.0% (CDK12), 25.0% (CHEK2), and 41.2% (other gene mutations). For how long those responses lasted, the independent review reported a median of 15.5 months for the BRCA group and 22.1 months for the other gene mutation group; data for the remaining groups was not reported for that measure. The reported data also shows that a PSA drop of at least 50% was recorded in 53.5% of the BRCA group, 36.0% of the other gene mutation group, 14.3% of the CHEK2 group, 7.1% of the CDK12 group, and 3.4% of the ATM group. A larger PSA drop of at least 90% was reported in 19.8% of the BRCA group, 16.0% of the other gene mutation group, 14.3% of the CHEK2 group, and 0% in both the ATM and CDK12 groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01517802 · results posted 10 May 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 31 participants, all of whom received a combination of abiraterone acetate plus prednisone or prednisolone. Thirty participants completed the study, while one did not. The trial was set up to track a specific type of safety-related event called a Serious Adverse Event (SAE) — meaning an unexpected medical problem that was life-threatening, required a hospital stay, caused lasting disability, resulted in death, or was otherwise considered a significant medical concern. The reported data shows that out of the 31 participants who started the trial, 16 experienced at least one Serious Adverse Event during the study period. No other outcome measures were included in the results data submitted to ClinicalTrials.gov for this trial, so no further figures are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02614859 · results posted 29 March 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT02614859) enrolled 29 men with prostate cancer across two groups. Nine participants received bicalutamide alone (a hormone-blocking medication), while 20 received a combination of bicalutamide and metformin (a medication commonly used for type 2 diabetes). The trial was measuring a number of things over 32 weeks, including changes in PSA levels (a protein in the blood often tracked in prostate cancer) and changes in body weight (measured by BMI — a standard height-to-weight ratio). The reported data shows that for the main outcome — the number of participants whose PSA became undetectable after 32 weeks — 3 out of 9 participants in the bicalutamide-only group reached this point, compared with 5 out of 20 in the combination group. For one of the secondary outcomes, a PSA drop of 85% or more at 32 weeks was recorded in 6 out of 9 participants in the bicalutamide-only group and 10 out of 20 in the combination group. The reported data also shows that after 8 weeks, 1 out of 9 participants in the bicalutamide-only group had any PSA decline, compared with 8 out of 20 in the combination group; the median (middle value) PSA decline at 8 weeks was not reported for the bicalutamide-only group, while the combination group had a median decline of 9%. Regarding BMI after 32 weeks, 4 out of 9 participants in the bicalutamide-only group and 12 out of 20 in the combination group had a recorded decrease. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02854436 · results posted 8 March 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 289 people with metastatic castration-resistant prostate cancer (a form of prostate cancer that has spread and no longer responds to standard hormone-lowering treatment). Of these, 223 were included in the main analysis group. All participants received a drug called niraparib. The trial was measuring how many participants' cancer visibly shrank or disappeared on scans, how long it took for the cancer to grow again, and how long participants lived overall. Participants were grouped according to whether they carried a particular gene mutation called BRCA (which can affect how cells repair their DNA) or not. The reported data shows that among participants with measurable cancer and a BRCA mutation, 34.2% had their cancer shrink or disappear (what the trial called an "objective response"). Among those without a BRCA mutation, this figure was lower, at 10.6%. For a separate measure looking at cancer cells detectable in the blood, 23.7% and 8.5% of participants (two figures were reported, likely reflecting the two gene-mutation subgroups) showed no detectable cancer cells in the blood at 8 weeks. The reported data shows that the time from enrolment until the cancer grew or participants passed away was reported as approximately 8.1 months and 3.7 months respectively for the two groups. Overall survival — the time from enrolment until death from any cause — was reported as approximately 13 months and 9.6 months for the two groups. No participants were recorded as having "completed" the trial, which the reported data does not explain further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03338790 · results posted 9 February 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 292 people with prostate cancer across four treatment groups — Arm A1 (88 people), Arm A2 (71 people), Arm B (84 people), and Arm C (49 people). The trial was measuring two main things: how many participants showed a meaningful shrinkage of tumours as seen on scans (called the objective response rate), and how many participants had their PSA level — a protein in the blood often tracked in prostate cancer — drop by at least half from their starting level (called the PSA response rate). It also tracked how long it took for the disease to progress on scans, how quickly a response appeared, how long a response lasted, and how long before PSA levels started rising again. The reported data shows that, for tumour shrinkage on scans, the percentage of participants who responded was 10.3% in Arm A1, 15.4% in Arm A2, 40.0% in Arm B, and 11.1% in Arm C (with a second set of figures — possibly from a different analysis — of 17.2%, 25.0%, 36.8%, and 20.0% respectively). For the PSA response, the reported rates were 11.9% in Arm A1, 27.3% in Arm A2, 46.9% in Arm B, and 34.1% in Arm C (second set: 18.2%, 41.9%, 50.0%, and 50.0%). The reported data also shows that the time before the disease progressed on scans ranged from approximately 4.6 months (Arm A1) to 9.2 months (Arm B), and the time before PSA levels progressed ranged from roughly 3.1 months (Arm C) to 8.7 months (Arm B). Where a duration of response was reported, it was approximately 7.1 months for Arm A2 and 7.2–7.4 months for Arm B; this figure was not reported for Arms A1 and C. The time from starting treatment until a first response was recorded was broadly similar across all arms, ranging from around 1.9 to 2.8 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03432897 · results posted 3 February 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03432897) enrolled just one participant in a single treatment group. The trial was investigating the use of olaparib (a type of medication) before a surgical procedure called a radical prostatectomy — an operation to remove the prostate gland — in a patient with locally advanced prostate cancer who had specific changes in their DNA repair genes. The study tracked a protein called PSA (prostate-specific antigen), which is measured through a blood test and is commonly monitored in prostate cancer care. The reported data shows that for the primary outcome — whether the participant's PSA level dropped by at least 50% from their starting level — the result was zero participants meeting that threshold. For the secondary outcomes, the reported data shows that the participant went 7 months without their PSA level rising by 25% or more from the starting point (a measure called "PSA progression-free survival," meaning the length of time before that kind of rise was seen). The trial also tracked how many participants were assessed for safety during the study, and the reported data shows that one participant (the only participant enrolled) was included in that assessment. No further detail about specific safety findings was reported in the structured data submitted to ClinicalTrials.gov. It is worth noting that because only one person took part in this trial, the numbers reported reflect the experience of a single individual and cannot be used to draw broader conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02489318 · results posted 18 January 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT02489318) enrolled 1,052 people with prostate cancer — 527 received a placebo alongside androgen deprivation therapy (ADT, a standard hormone treatment that lowers testosterone), and 525 received a drug called apalutamide alongside ADT. The trial was measuring two main things: how long participants went without their cancer visibly spreading on scans (called radiographic progression-free survival), and how long participants lived overall (overall survival). It also tracked several secondary measures, including time until chemotherapy was needed, time until pain worsened, time until strong pain medicines were needed regularly, and time until a bone-related complication occurred. The reported data shows that, for the placebo plus ADT group, the median time before cancer visibly spread on scans or death occurred was approximately 22 months. For the apalutamide plus ADT group, this figure was listed as "NA" (not available/not reported) in the submitted data. Similarly, the median overall survival for the placebo plus ADT group was reported as approximately 52 months, while the figure for the apalutamide plus ADT group was again listed as not available in the submitted results. For all five secondary outcome measures — time to chemotherapy, time to pain progression, time to regular strong pain medicine use, and time to bone-related complications — the values were not reported for either group in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02830165 · results posted 6 January 2022
According to the results reported on ClinicalTrials.gov, this trial involved 11 people, all of whom received a type of targeted radiation treatment called Stereotactic Body Radiation Therapy (SBRT) for prostate cancer. All 11 participants completed the study. The trial was primarily measuring whether participants could complete the maximum allowed time on the study without experiencing severe acute surgical complications. It also looked at side effects on the bladder and bowel, quality of life, urinary symptoms, and took tissue and blood samples to study biological markers related to the treatment. The reported data shows that all 11 participants met the primary measure — that is, none experienced severe acute surgical complications during the study period. For side effects on the bladder and bowel (rated on a scale where Grade 1 is mild, Grade 2 is moderate, and Grade 3 is severe), the reported numbers show varying counts of participants across different grades and types of side effects, though the data as submitted does not clearly label which specific numbers correspond to which individual side effect categories, so a fully detailed breakdown cannot be provided here. For quality of life, scores were measured using a 26-item questionnaire (where higher scores mean better quality of life); the reported changes from the start of the study to 12 months ranged from a small decline of 1.6 points in one area to a larger decline of 34.4 points in another area across five different domains. A separate urinary symptom score (rated 0–35, with higher meaning more symptoms) showed an average reported change of plus 0.5 points. Tissue and blood sample analyses measured immune cell levels before and after treatment, with the reported figures varying between the two time points, though the clinical meaning of these numbers was not explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03712930 · results posted 17 November 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03712930) enrolled 13 participants, all of whom received a medicine called pamiparib. None of the 13 participants completed the study — all 13 left before it concluded, though the data does not explain why. The trial was measuring how pamiparib performed in this group by looking at two main things: whether tumours shrank (called objective response rate, or ORR — meaning the proportion of people whose cancer showed a complete or partial reduction in size), and whether a blood protein called PSA dropped by at least half from its starting level (PSA is often used as a marker in prostate cancer). The reported data shows that for both of those main measures, the result was 0% — meaning none of the 13 participants were recorded as having their tumour shrink to the required level, and none were recorded as having their PSA fall by 50% or more. Among the additional measures, the investigators also recorded 0% for tumour shrinkage when assessed by the treating doctors themselves. Because no participants showed a tumour response, the figures for "how long a response lasted" and "how long it took to respond" could not be calculated and were not reported. One additional measure — called clinical benefit rate — looks at a broader group of outcomes including stable disease (where the cancer neither grew nor shrank significantly). The reported data shows that 25% of participants (roughly 3 out of 13) met that broader measure. It is worth noting that with only 13 participants, this was a very small study, and the data as submitted does not include context about why all participants left before completing the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03150056 · results posted 26 August 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03150056) enrolled 73 participants in total across six groups. Each group received a different dose or schedule of an investigational drug called GSK525762 combined with one of two other medicines already used for prostate cancer — either abiraterone or enzalutamide. The trial was measuring a range of things, including how many participants experienced unwanted medical events (called adverse events), whether their PSA level — a protein in the blood often monitored in prostate cancer — dropped by at least half, and how the investigational drug moved through participants' bodies. The reported data shows that across all six groups, every participant who started the trial experienced at least one adverse event. Serious adverse events (those involving hospitalisation, being life-threatening, resulting in death, or other significant medical situations) were reported in 4 out of 10, 2 out of 6, 0 out of 4, 1 out of 10, 6 out of 22, and 7 out of 21 participants respectively across the six groups. Adverse events led to dose reductions or delays in a notable proportion of participants in most groups, and withdrawals due to toxicity (side effects severe enough to stop treatment) ranged from 2 to 8 participants depending on the group. Regarding the PSA measurement, the reported data shows that zero participants in any group achieved a 50% or greater drop in PSA from their starting level. For the drug's behaviour in the bloodstream, the reported peak concentration of GSK525762 in the blood ranged across groups, with higher figures generally seen in the groups combined with abiraterone than those combined with enzalutamide; the time to reach that peak was under one hour in most groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03803475 · results posted 24 August 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 485 people with prostate cancer, of whom 484 completed the study. All participants received a type of nuclear medicine scan called a Ga-68 PSMA-11 PET scan — a specialised imaging test that looks for signs of prostate cancer that may have spread in the body. The trial was measuring how often the scan picked up cancer in different parts of the body (the prostate bed, pelvic lymph nodes, distant soft tissues, and bones), and how those results changed depending on the level of a blood marker called PSA (prostate-specific antigen) at the time of the scan. PSA is a protein measured in the blood that can rise when prostate cancer is present or progressing. The reported data shows that, overall, the scan detected signs of cancer spread in proportions ranging from 0.38 to 0.82 (meaning roughly 38% to 82% of participants in different PSA groups had positive findings), with higher PSA levels generally corresponding to higher detection proportions. When looking at specific locations, detection in the prostate bed area ranged from 0.09 to 0.76 across PSA groups; in the pelvic lymph nodes it ranged from 0.10 to 0.51; in distant soft tissues it ranged from 0.09 to 0.30; and in the bones it ranged from 0.03 to 0.26. The reported data shows that, across all locations, the proportions tended to be lower in groups with lower PSA levels and higher in groups with higher PSA levels, though the pattern varied by location. It is important to note that these figures represent the proportions of participants whose scans were read as positive by local imaging specialists — they describe what the scan detected, not treatment outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02257736 · results posted 16 August 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02257736) enrolled 982 people with prostate cancer — 490 received a placebo combined with abiraterone acetate and prednisolone, while 492 received apalutamide combined with abiraterone acetate and prednisolone. The trial's main goal was to measure how long it took for cancer to visibly progress on scans (called "radiographic progression-free survival"), and a number of secondary goals were also tracked, including how long participants lived overall, how long before they needed strong pain medicines (opioids), how long before they started chemotherapy, and how long before their pain worsened. The reported data shows that, for the main outcome, the placebo group went a reported median (meaning the midpoint value across the group) of around 16.6 months before scan-visible progression, compared with around 24.0 months in the apalutamide group. For overall survival, the reported median time was around 33.7 months in the placebo group and around 36.2 months in the apalutamide group. For the time before starting chemotherapy, the reported figures were around 34.2 months and 36.1 months respectively. The reported data shows that for time to first opioid use, the placebo group reached that point at a reported median of around 53.3 months, compared with around 47.0 months in the apalutamide group. For time to pain progression, the placebo group reached that point at around 26.5 months, compared with around 21.8 months in the apalutamide group. It is worth noting that a large proportion of participants in both groups did not complete the study — around 451 and 447 respectively — which the trial data does not fully explain. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00116142 · results posted 28 July 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 350 men with prostate cancer — 175 in each group. One group received androgen suppression therapy (hormone treatment to lower testosterone) combined with radiation therapy, while the other group received the same treatments plus a chemotherapy drug called docetaxel. The trial was measuring how long participants lived overall, whether their PSA levels rose again after treatment (a sign the cancer may be returning), and how many participants experienced side effects. The reported data shows that when looking at overall survival over 10 years, the average time participants were alive was 8.82 years in the hormone-plus-radiation group and 9.11 years in the group that also received docetaxel. For PSA recurrence — meaning a significant rise in PSA blood test levels, which can suggest the cancer is active again — the reported 10-year rates were 48% in the hormone-plus-radiation group and 54% in the docetaxel group. The reported 10-year prostate cancer death rate was 11% in the hormone-plus-radiation group and 15% in the docetaxel group. Regarding side effects, 18 participants in the hormone-plus-radiation group and 46 in the docetaxel group reported acute (short-term) adverse events serious enough to be formally recorded. For longer-term side effects — including urinary and bowel-related issues — 128 participants in the hormone-plus-radiation group and 140 in the docetaxel group had at least one such event reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00667862 · results posted 21 June 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 35 participants, all of whom received a drug called panobinostat. The trial was measuring how many people with prostate cancer went 24 weeks without their disease getting worse (known as "progression-free survival"), as well as other measures such as tumour response, changes in a prostate-specific blood marker called PSA, and how long participants' disease stayed stable. The reported data shows that at the 24-week mark, approximately 11.4% of participants (roughly 4 out of 35) had not experienced disease progression and were still alive — this was the main result the trial was designed to measure. For the secondary measures, the reported data shows that 0% of participants had a confirmed tumour response (meaning no one's tumour shrank enough to meet the study's definition of a meaningful reduction). Similarly, 0% of participants showed a meaningful drop in their PSA blood level. On the other hand, 48.6% of participants (roughly 17 out of 35) experienced a notable rise in their PSA levels by 24 weeks, which the study defined as disease progression by that measure. The figures for how long participants' disease stayed stable, and for the median progression-free survival time, were not reported in the submitted data. It is also worth noting that none of the 35 participants were recorded as having "completed" the study — all 35 did not complete it, though the reasons for this were not detailed in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02135653 · results posted 19 May 2021
According to the results reported on ClinicalTrials.gov, this trial looked at whether adding a specific style of yoga (called Eischens Yoga) alongside radiotherapy made a difference for people receiving cancer treatment. A total of 68 people took part — 35 in the group that did radiotherapy plus yoga, and 33 in the group that did radiotherapy alone. Of those, 22 and 28 people respectively completed the study. The trial measured adverse events (unexpected or harmful occurrences during the trial) as its main focus, and also used several questionnaires to track how participants felt in terms of fatigue, physical wellbeing, social wellbeing, emotional wellbeing, and day-to-day functioning. The reported data shows that zero adverse events were recorded in either group. For fatigue — measured on a scale from 0 to 90, where a higher number means greater fatigue — the yoga group scored 12.2 and the non-yoga group scored 27.4. For physical wellbeing — scored from 0 to 35, where higher means better — the yoga group scored 24.9 and the non-yoga group scored 24.3. For social wellbeing (also 0–35, higher is better), the reported scores were 23.5 for the yoga group and 21.4 for the non-yoga group. For emotional wellbeing (0–30, higher is better), the scores were 20.1 and 21.0 respectively. For day-to-day functional wellbeing (0–35, higher is better), the yoga group scored 22.5 compared to 21.4 in the non-yoga group. These figures are the scores as reported, and this summary does not draw any conclusions about what caused any differences between the groups or what the numbers mean for any individual. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01540071 · results posted 14 May 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 38 men with advanced prostate cancer that had stopped responding to both hormone-lowering treatments (castration) and a type of chemotherapy called taxanes. All 38 participants completed the study — none dropped out. The trial was testing an investigational drug called NRX 194204, and the main thing it was measuring was "clinical benefit," which the researchers defined as either the cancer not getting worse at 8 weeks, or showing a measurable response at any point, without unacceptable side effects requiring the treatment to be stopped. The reported data shows that 19 out of 38 participants met the definition of clinical benefit described above. For the secondary measures, the reported data shows that the median overall survival — that is, the midpoint survival time across participants — was 312 days. The median time until the disease was recorded as progressing (getting worse by set criteria) was 105 days. Regarding a specific blood marker for prostate cancer called PSA, the reported data shows 1 participant had a 50% or greater reduction in PSA levels from their starting level, 6 participants had some reduction that did not reach 50%, and 29 participants did not have a PSA reduction. The reported data also shows there were 23 side effects recorded at Grade 3 or higher (meaning severe or serious) that were considered at least possibly linked to the study drug. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03085095 · results posted 25 March 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03085095) enrolled 624 men in the relugolix group and 310 men in the leuprolide acetate group, for a total of 934 participants. The trial was measuring how well each treatment lowered testosterone to a level below 50 ng/dL (a threshold commonly used in prostate cancer treatment research), and how quickly that happened. It also looked at changes in a prostate cancer protein marker called PSA, and levels of another hormone called FSH. The reported data shows that, for the main outcome — the proportion of men who sustained low testosterone levels over the course of the study — 96.7% of men in the relugolix group and 88.8% in the leuprolide acetate group met this threshold (these figures are estimates based on a statistical method called Kaplan-Meier, which accounts for participants who left the study early). For the secondary outcomes, the reported data shows notable differences in how quickly testosterone dropped: by Day 4 of Week 1, 56% of the relugolix group had reached the low-testosterone threshold compared with 0% in the leuprolide group; by the start of Week 3, this was 98.7% versus 12.1%. A deeper level of testosterone suppression (below 20 ng/dL) was also measured at Week 3, with 78.4% in the relugolix group reaching that level compared with 1% in the leuprolide group. The reported data also shows that 79.4% of the relugolix group had a confirmed reduction in PSA of more than 50% from their starting level (measured at Weeks 3 and 5), compared with 19.8% in the leuprolide group. Average FSH hormone levels were reported as 1.72 IU/L in the relugolix group and 5.95 IU/L in the leuprolide group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01812668 · results posted 23 March 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants, all of whom completed the study. Every participant received the study drug, cabozantinib-s-malate. The trial was measuring several things: how much a type of body scan reading (called a PET scan SUV — a way of measuring activity in tumour tissue) changed after treatment, how long it took for disease to progress, how participants' tumours responded on scans, and changes in a prostate-specific blood marker called PSA. The reported data shows that, on average, the PET scan activity reading fell by 56% from before to after treatment. The reported median time to progression (that is, the midpoint estimate for how long it took before the disease got worse) was 4.1 months. When tumour response was assessed using a standard measurement system called RECIST 1.1, 6 out of 20 participants showed a clinical response on conventional scans, 8 out of 20 showed a PSA response, and 19 out of 20 showed a response on PET scans. The reported data also shows that a number of participants experienced side effects rated as grade 3 or higher (meaning more severe), with 11 participants recorded for one particular side effect category — the full breakdown across multiple side effect types was also reported, with counts ranging from 1 to 3 participants for each individual type listed. It is important to note that this trial had no comparison group, so all results reflect only the single group that received the study drug. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03672396 · results posted 12 January 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03672396) enrolled 22 men with a form of advanced prostate cancer (called metastatic castrate resistant prostate cancer) who were also receiving hormone-blocking treatment. All 22 participants started the study, and 16 completed it, with 6 not finishing. The trial was testing whether a 12-week home-based exercise program was feasible for this group — in other words, whether it was practical to carry out and measure. It was a single-group study, meaning there was no comparison group; everyone took part in the same exercise program. The reported data shows that 16 out of 22 participants completed the before-and-after testing, which was the main thing the trial set out to measure. For exercise adherence (how consistently participants stuck to the program), the reported figures were 80.1%, 65.5%, and 72.8% across different components of the program — the trial set a target of completing at least 75% of all prescribed sessions. Several physical function tests were also measured before and after the program. The reported data shows: a short 6-metre walk took an average of 4.4 seconds before and 4.5 seconds after; a "timed up and go" test (standing, walking a short distance, and returning) took 10.4 seconds before and 10.8 seconds after; a stair climb took 6.4 seconds before and 6.2 seconds after; and a 400-metre walk took 329.8 seconds before and 313.5 seconds after. The trial did not report whether any differences between these before-and-after numbers were considered meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03664193 · results posted 5 January 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants, all of whom completed the study — none dropped out. It was a single-arm study, meaning everyone received the same treatment rather than being split into comparison groups. The trial was looking at a type of targeted radiation treatment for prostate cancer called Stereotactic Body Radiotherapy (SBRT) with a Simultaneous Integrated Boost (SIB) — a technique that delivers a higher radiation dose to a specific area within the tumour at the same time as treating the surrounding tissue. The trial was primarily testing whether treatment plans at different radiation dose levels could be delivered while meeting safety planning targets, and whether participants could complete treatment without experiencing severe side effects (rated Grade 3 or higher) affecting the urinary or bowel systems. The reported data shows that of the 30 participants, treatment plans were delivered at four different dose levels: 9 participants received 37.5 Gy, 14 received 40 Gy, 2 received 42.5 Gy, and 5 received 45 Gy. All 30 participants were reported to have received their treatment without experiencing side effects greater than Grade 3 in the urinary or bowel areas (Grade 3 means severe side effects requiring medical intervention — the reported data indicates none reached this level or above). For quality-of-life scores, participants completed two questionnaires. The EPIC questionnaire (scored 0–100, where higher means better) returned eight scores across different domains, ranging from 53.3 to 94.2 — the specific domains these scores relate to were not separately labelled in the reported data. The AUA urinary symptom questionnaire (scored 0–35, where lower means less bothersome) returned a score of 6 at both time points measured, which falls in the "mild" range according to the scale's own categories. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03481816 · results posted 22 December 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03481816) enrolled 18 people in total. Six participants joined a dose de-escalation arm, where the goal was to find the right dose of a vaccine-based treatment, and 12 participants joined a dose expansion arm, where that chosen dose was tested in a broader group. The trial was primarily measuring whether serious side effects — called dose-limiting toxicities — occurred within the first 28 days, and what dose should be taken forward into future research. The reported data shows that none of the participants in either group experienced a dose-limiting toxicity. The recommended dose identified for potential future studies was reported as 500 billion viral particles. For the secondary outcomes, which looked at how tumours responded to treatment: in the dose de-escalation group, 0% of participants showed a measurable reduction in tumour size; in the dose expansion group, 8.3% showed a measurable tumour reduction. When looking at disease control lasting at least 6 months — meaning tumour size either shrank or stayed stable — the reported figure for the dose expansion group was 41.6%, while it was 0% in the de-escalation group. Among those in the expansion group who did show a tumour response, the reported duration of that response was 16 weeks. The reported median time before disease progression or death in the expansion group was 22 weeks. No duration of response data was reported for the de-escalation group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02919111 · results posted 10 December 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 299 people with prostate cancer, and all 299 completed the study. The trial was testing a type of PET scan using a radioactive tracer called Ga-68 PSMA-11, which is designed to detect prostate cancer cells in the body. The main goal was to see how well this scan could identify whether cancer had spread to nearby lymph nodes (glands that are part of the immune system) in the pelvis, by comparing the scan results to tissue samples taken during surgery to remove the prostate. The reported data shows four key measures for detecting cancer spread to pelvic lymph nodes. First, **sensitivity** — how often the scan correctly spotted lymph nodes that did have cancer — was reported as 0.43, meaning the scan identified cancer in roughly 43 out of every 100 cases where cancer was actually present in the nodes. Second, **specificity** — how often the scan correctly showed no cancer in nodes that were genuinely cancer-free — was reported as 0.94, or about 94 out of 100 such cases. Third, the **positive predictive value** (how often a "positive" scan result truly reflected cancer being present) was reported as 0.64, or about 64 in 100. Fourth, the **negative predictive value** (how often a "negative" scan result truly meant no cancer was present) was reported as 0.87, or about 87 in 100. For one of the secondary measures — detecting cancer spread to lymph nodes outside the pelvis — no results were reported in the data. Separately, the reported data shows that zero participants experienced a serious (Grade 3 or above) scan-related adverse event, though this describes what was recorded rather than a conclusion about safety. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03035032 · results posted 9 December 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 107 participants, all of whom received a drug called leuprolide acetate 22.5 mg (brand name Eligard), given as an injection for prostate cancer. By the end of the study, 64 participants had completed it, while 43 did not finish. The trial was measuring unwanted medical events (called adverse events) linked to the drug, as well as changes in two markers commonly tracked in prostate cancer — testosterone levels in the blood and PSA (prostate-specific antigen, a protein produced by the prostate that doctors use to monitor prostate cancer). The reported data shows that 15 out of 107 participants experienced an adverse event considered related to the drug, and 2 of those were classified as serious (meaning they involved hospitalisation, were life-threatening, caused significant disability, or were otherwise medically important). Regarding testosterone levels at 12 months, the reported figures show that 51.4% of participants had levels below 20 ng/dL (nanograms per decilitre, a measure of concentration in the blood), 12.4% were in the 20–50 ng/dL range, and 1.9% were above 50 ng/dL; similar patterns were reported at 18 months. For PSA, the reported data shows that across each measurement point from months 3 to 18, between roughly 91% and 97% of participants had a PSA reading at least 30% lower than their starting level, and between roughly 89% and 97% had a PSA reading at least 50% lower. The reported median time to PSA progression (when PSA started rising again by a defined amount) was 8.80 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01753297 · results posted 9 December 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 117 people in an "active surveillance" group (meaning they were monitored but received no additional treatment) and 109 people in a group that received a hormone therapy called triptorelin. The trial was set up to measure whether triptorelin could delay a rise in a blood marker called PSA (a protein that can signal prostate cancer activity) after the participants had already received radiotherapy. A PSA rise above a certain level, confirmed by a second test, was called a "biochemical relapse" (BR). In total, 226 people started the trial, and 149 completed it. The reported data shows that the main goal was to look at how long it took before participants experienced a biochemical relapse. The trial was designed to analyse results once 61 such events had occurred across both groups. According to the results reported on ClinicalTrials.gov, 35 participants in the active surveillance group and 26 in the triptorelin group experienced a biochemical relapse. Because not enough relapse events occurred to calculate a midpoint ("median") time for either group, the researchers instead reported what is called a "Q1 time" — the point by which one quarter of participants in each group had experienced a relapse. That figure was reported as 30.0 months for the active surveillance group and 39.1 months for the triptorelin group. For the secondary measures — including time to disease progression, death-free survival, and overall survival — the reported data shows that the median figures were not reached for either group, and no Q1 figures were reported for those outcomes either. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01977651 · results posted 9 December 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT01977651) enrolled 423 participants, all of whom received a daily oral dose of enzalutamide (160 mg). The trial had one treatment group only — there was no comparison or placebo group. The main thing the trial was set up to measure was how many participants experienced at least one confirmed seizure (a sudden episode of uncontrolled electrical activity in the brain) during the first four months of taking the medication. The seizure events were reviewed and confirmed by an independent panel of medical experts. Of the 423 who started, 322 completed the initial four-month period. A smaller group then continued into an extended follow-up phase lasting up to a further year, and a subset continued beyond that. The reported data shows that, among the participants whose results could be evaluated, 1.1% had at least one confirmed seizure during the first four months of treatment. No secondary outcome measure data appears to have been included in the structured results submitted to ClinicalTrials.gov, so those figures are not available to report here. It is also worth noting that this trial did not include a comparison group, so the reported seizure percentage cannot be directly compared against an untreated or differently treated group within this study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03490032 · results posted 17 November 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03490032) involved 30 participants across three groups: 6 people with biochemically recurrent prostate cancer (meaning their PSA blood marker had risen after earlier treatment) who took part in the first phase of the study, and 12 people from the same type of cancer plus 12 people with metastatic prostate cancer (cancer that had spread to other parts of the body) who took part in the second phase. The trial was measuring how a radioactive imaging agent called 68Ga-PSMA-R2 behaved in the body when used in PET/CT scans — a type of detailed imaging scan — and tracking any unwanted side effects that occurred after it was given. The reported data shows that in terms of unwanted effects (called treatment-emergent adverse events, meaning any new or worsening health issue that appeared after the injection), 1 participant in the first-phase recurrent cancer group, 4 in the second-phase recurrent cancer group, and 2 in the metastatic cancer group experienced such events. One participant in the second-phase recurrent cancer group experienced a serious adverse event. No deaths due to the agent were reported in any group. The reported data also shows technical measurements about how the imaging agent moved through the body: it had a half-life (the time it takes for half the agent to leave the bloodstream) of approximately 2.83 hours, and the rate at which it was cleared through urine was reported as 5,870 mL per hour. Measurements of how much of the agent was detected in various organs — including the kidneys, liver, salivary glands, and others — at different time points after injection were also recorded, with the kidneys showing among the higher levels of uptake in the reported figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02987543 · results posted 12 October 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02987543) enrolled a total of 387 people with prostate cancer across four groups. Two groups (called Cohort A) received either olaparib tablets (162 people) or a doctor's choice of a hormone-blocking medicine known as a "new hormonal agent" or NHA (83 people). Two further groups (called Cohort B) followed the same pattern — olaparib (94 people) or doctor's choice of NHA (48 people). The trial was primarily measuring how long participants went without their cancer visibly growing on scans, which is called "radiological progression-free survival." It is worth noting that the data shows none of the participants were recorded as having "completed" the study in the formal sense, meaning all participants exited early for various reasons — this is not unusual in cancer trials but means the data reflects an incomplete follow-through for all enrolled individuals. The reported data shows that for the primary outcome in Cohort A, the olaparib group had a median time before scan-detected cancer growth (or death) of 7.39 months, compared with 3.55 months in the NHA group. For a related secondary measure looking at both Cohort A and B together, those figures were 5.82 months versus 3.52 months respectively. In Cohort A, 28 out of 56 participants in the olaparib group and 1 out of 42 in the NHA group were reported to have had a measurable shrinkage in their tumours on scans. For time to worsening pain in Cohort A, the reported data shows 9.92 months for the NHA group; the corresponding figure for the olaparib group was not reported in the data. Regarding overall survival in Cohort A, the data reports counts of participants at certain time points rather than a median survival figure — for example, 91 olaparib and 57 NHA participants were counted at one time point, 49 versus 21 at another, and 22 versus 5 at a third — however, what those time points specifically represent was not clearly defined in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01352598 · results posted 23 September 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 84 people, all of whom received a type of focused radiation treatment called Stereotactic Body Radiotherapy, which delivers high doses of radiation precisely targeted at the prostate. The trial was measuring two main things: how well the treatment kept prostate cancer from coming back (using a blood marker called PSA, which can signal whether cancer is growing), and how many participants experienced side effects in the year following treatment. The reported data shows that, of the 72 people who completed the study, 71 participants had their PSA levels remain at a controlled level — meaning the cancer did not show signs of returning by the measure used — while 0 participants were recorded as having their cancer progress by that measure. For side effects recorded within one year of treatment, the reported data shows that out of 68 participants assessed, 6 experienced adverse events (unwanted health effects) that were recorded as part of that measure. It is worth noting that 12 people did not complete the study, though the reasons for this were not reported in the data provided. These numbers are the raw figures submitted to the trial registry; they do not tell us the full picture on their own, and the data for some details — such as why participants left the study — was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01194271 · results posted 3 September 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 19 people, all of whom received a treatment called ipilimumab before surgery (referred to as "neoadjuvant" treatment, meaning given before an operation). The trial was measuring how the immune system — the body's natural defence system — responded to the treatment. Specifically, researchers tracked three markers on immune cells (CD4, CD8, and ICOS) that indicate different types of immune activity. Of the 19 who started, 16 completed the study and 3 did not. The reported data shows that the trial's main goal was to count how many participants showed a notable increase (at least a doubling) in each of these three immune cell markers compared to where they started. According to the results reported on ClinicalTrials.gov, 12 out of 19 participants showed this doubling in CD4 markers (cells that help coordinate the immune response), 7 out of 19 showed it for CD8 markers (cells involved in directly targeting invaders), and 9 out of 19 showed it for ICOS markers (a molecule that stimulates immune cell activity). These numbers reflect how many people showed a change in these measurements — the trial did not report on other aspects such as longer-term outcomes in this data submission. It is worth noting that no secondary outcome measure data was included in the structured results provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01807065 · results posted 25 August 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 51 men in total — 25 in one group who received a treatment called sipuleucel-T on its own (Arm A), and 26 in a second group who received radiation therapy together with sipuleucel-T (Arm B). Nearly all participants completed the study (24 and 25 respectively, with one person in each group not completing). The trial was primarily measuring how long participants went without their cancer getting worse — known as "progression-free survival" — and also tracked certain unwanted side effects rated as moderate or above in severity. The reported data shows that, on average, participants in Arm A (sipuleucel-T alone) went approximately 2.46 months before signs of progression were recorded, while participants in Arm B (radiation therapy plus sipuleucel-T) went approximately 3.65 months. These figures were estimated using a standard statistical method for tracking time-based outcomes in clinical trials. Regarding side effects, the reported data shows small numbers of participants in each group experienced moderate-to-severe treatment-related adverse events across several categories — for example, 3 participants in Arm A and 0 in Arm B had one particular type of side effect, while other individual side effect categories each affected between 0 and 2 participants across the two groups. The trial data does not provide labels identifying what each specific side effect category was, so a full breakdown cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01800058 · results posted 26 June 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 66 people with prostate cancer, and 65 of them completed the study. The trial was looking at whether tiny cancer cells could be detected circulating in participants' bloodstream (known as circulating tumour cells), using a threshold of more than one such cell per 7.5 mL of blood as the reference point. The study tracked these cell counts at several different time points during treatment. The reported data shows that at the first measurement point, 60 out of 65 participants had detectable circulating tumour cells, while 5 did not. At a second time point, 54 participants had detectable cells, 8 did not, and data for 3 participants was not clearly categorised in the reported results. At a third time point, 48 participants had detectable cells, 11 did not, and 6 fell into a separate category. At a later measurement point, 12 participants had detectable cells and 1 did not — though it is worth noting the total at this point was smaller, and the reported data does not explain the difference in numbers across time points. For the secondary outcomes, the reported data shows that 64 out of 65 participants had not experienced a biochemical failure (a rise in a prostate-specific blood marker beyond a set level) by the end of follow-up, while 1 had. Regarding overall survival, 59 participants were recorded as alive and 6 had died from any cause by the end of the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03827473 · results posted 25 June 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03827473) was designed to compare two treatment combinations for prostate cancer — one combining hormone therapy (ADT) with docetaxel (Arm A), and the other combining hormone therapy with abiraterone (Arm B). The trial planned to enrol participants into both arms and follow them for up to 18 months, measuring quality of life and a protein marker in the blood called PSA (prostate-specific antigen, a substance sometimes tracked in prostate cancer care). However, only one person was enrolled into Arm A, and no one was enrolled into Arm B. Because the single participant was only followed for 3 months rather than the planned 12, the results reported are very limited. The reported data shows that for the one participant in Arm A, quality of life scores — measured using a questionnaire called FACT-P (where higher numbers out of 156 mean better quality of life) — were 139.83 at the start and 127 at 3 months. A separate questionnaire measuring nerve-related side effects (FACT/GOG-NTX, out of 152) recorded scores of 131.83 at the start and 126 at 3 months. A fatigue questionnaire (PROMIS Fatigue, where higher scores out of 35 mean more fatigue) recorded 10 at the start and 16 at 3 months. For the secondary outcomes, the reported data shows that this one participant did meet the definition of a PSA response (a drop of 90% or more from their starting PSA level), and had also not shown PSA progression by the end of their 3-month follow-up period. No data was reported for Arm B, as no participants were enrolled in that group. It is important to note that because only one person participated and the study ended far earlier than planned, the reported data provides extremely limited information. No meaningful comparisons between the two treatment arms can be drawn from these results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01599793 · results posted 26 March 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 19 participants, all of whom received the study treatment — an enzyme inhibitor therapy (XL184). Seventeen participants completed the study, while two did not finish. The trial was primarily looking at changes in a specialised MRI measurement called Ktrans, which tracks how blood flows through tumour tissue. It also tracked several secondary measures, including how long participants went without their disease getting worse (progression-free survival), changes in bone scans, a prostate-specific blood marker called PSA, and two other measures involving tumour size and circulating tumour cells. The reported data shows that the primary MRI measurement (Ktrans) changed by an average of 0.026 per minute between the start of the study and the two-week mark. For the secondary outcomes, the reported median time until disease progression or death was approximately 5.1 months. Bone scan scores showed an average change of −0.44 on the study's scoring scale (where a negative number reflects a shift toward fewer or more stable bone lesions). The reported data shows a change in PSA levels of 453.04 ng/mL between the start of the study and 12 weeks — though it is worth noting this is simply the average change observed across participants, not a judgment about what that change means. Two planned secondary measures — tumour size (using standard RECIST measurements) and circulating tumour cell counts — were not collected, and therefore no data was reported for those outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03634579 · results posted 23 March 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 9 participants, all of whom received a procedure called MRI-guided Focal Laser Ablation — a technique that uses laser energy, guided by MRI scans, to target prostate cancer tissue. The trial was measuring several things: whether prostate cancer came back after one or two years, whether there were any serious complications from the procedure, and whether participants experienced any changes in their erectile (sexual) or urinary function. The reported data shows that none of the 9 participants were recorded as having formally "completed" the study. For the primary measure of cancer recurrence at one year, no numerical results were reported in the data submitted to ClinicalTrials.gov. Similarly, no figures were reported for cancer recurrence at the two-year mark (a secondary measure). For serious complications — defined in this trial as grade 3 or higher, meaning severe or life-threatening events — the reported figure was 0%. Regarding changes in sexual function, the reported data shows 1 out of 9 participants was recorded as having experienced a change. For urinary function, 3 out of 9 participants were recorded as having experienced a change. No further detail about the nature or extent of those changes was included in the submitted data. It is worth noting that because none of the 9 participants were recorded as having completed the study, the results above should be understood as very limited and incomplete. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01790126 · results posted 11 March 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT01790126) enrolled 90 men with prostate cancer across three treatment groups: one group received a hormone-suppressing injection called an LHRHa (30 participants), one group received a tablet called apalutamide (29 participants), and one group received both treatments combined (31 participants). The trial was primarily measuring changes in quality of life — how participants felt physically, emotionally, socially, and functionally — using a standardised questionnaire called the FACT-P, which is scored from 0 to 156 where higher scores mean better quality of life. Notably, the reported data shows that zero participants were recorded as having "completed" the study in the usual sense, with all participants listed under "not completed," though the reasons for this were not detailed in the submitted data. The reported data shows that at 12 months — the main measurement point — all three groups had lower FACT-P scores compared to where they started (meaning scores moved in a downward direction from baseline). The LHRHa-only group's score dropped by about 8 points on average, the apalutamide-only group dropped by about 6.6 points, and the combined group dropped by about 9.4 points. On the secondary quality-of-life questionnaires (EORTC QLQ-C30 and QLQ-PR25), the reported changes were generally small across all groups and time points. For sexual function (measured by the SHIM questionnaire, scored 5–25 with higher meaning better function), all three groups reported lower scores at every time point measured — drops of roughly 2 to 4 points. For the time it took for a prostate-specific antigen (PSA — a protein measured in the blood often used to track prostate cancer) level to rise by a defined amount, the reported figures were approximately 31 months for the LHRHa group, 26 months for the apalutamide group, and 36 months for the combined group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03264456 · results posted 22 January 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 18 people, all of whom underwent a specialised type of medical imaging called \[18F\] Fluciclovine PET/MRI — a scan that combines two imaging technologies and uses a radioactive tracer to help detect prostate cancer. Fourteen participants completed the study, and four did not finish. The trial was measuring how well this imaging approach could spot the primary (main) tumour and any spread to nearby lymph nodes (small glands that are part of the immune system), and also how the scan results changed after eight weeks of hormone-lowering treatment. The reported data shows that out of the 14 participants who completed the study, the primary tumour was detected in all 14 using the PET/MRI scan. When it came to lymph node involvement, the PET/MRI scan detected spread in 7 of the 14 participants. The reported data also shows a secondary comparison: when using standard MRI alone (without the special tracer), lymph node involvement was detected in only 3 participants, compared to 7 detected with the combined PET/MRI approach. For participants who had a follow-up scan after eight weeks of hormone-lowering treatment, the reported data shows that a measure of tracer uptake in the primary tumour — known as "maximum SUV" (a number reflecting how strongly the tracer is absorbed, which can indicate tumour activity) — went from an average of 7.1 before treatment to 3.5 afterwards. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02677896 · results posted 21 January 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02677896) enrolled 574 men in the enzalutamide plus hormone therapy group and 576 in the placebo plus hormone therapy group, for a total of 1,150 participants. The trial was studying men with prostate cancer and was primarily measuring how long it took for the cancer to show signs of spreading or worsening on scans — a measure called "radiographic progression-free survival" — comparing those who received enzalutamide alongside standard hormone therapy against those who received a dummy pill alongside the same hormone therapy. The reported data shows that for the placebo group, the median time before the cancer showed signs of progressing on scans was 19.4 months using one measuring method, and 19.0 months using a second, slightly different method. A median is the midpoint — meaning half of participants in that group reached that point sooner, and half took longer. The corresponding figures for the enzalutamide group were recorded as "NA" (not available), which typically occurs when so few people in that group had reached the progression point by the time the data was analysed that a median could not be calculated. For overall survival (how long participants lived) and time to PSA progression (a blood marker used to track prostate cancer), the reported data shows "NA" for both groups, meaning those figures were not reported in the submitted results. For the secondary measure of time until participants needed to start a new cancer treatment, the placebo group's median was reported as 40.5 months; again, the enzalutamide group's figure was not reported. Finally, the reported data shows that 68.1% of participants in the enzalutamide group had PSA levels drop to an undetectable level at some point during treatment, compared with 17.6% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02830880 · results posted 18 December 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02830880) enrolled 7 participants, all of whom received FACBC PET-CT imaging — a type of scan that uses a radioactive tracer to detect prostate cancer cells. The trial was measuring how well this imaging approach could track changes in prostate cancer during treatment, using several methods: specialised PET scans, blood tests for a protein called PSA (prostate-specific antigen, a marker commonly associated with prostate cancer activity), CT scans, MRI scans, and bone scans. Seven participants started the trial, and 4 completed it, with 3 not completing it. The reported data shows a range of figures across the different measurements. For the PET scan results, two percentage-change values were recorded — 3.2% and 23.5% — where a positive number indicates greater uptake of the tracer by cancer cells compared to the start of the study. Three PSA blood-test readings were reported: 249.8, 245.3, and 39.9 nanograms per millilitre (ng/mL). For the CT scan assessments of treatment response, the reported data shows 4 participants were categorised as having "stable disease" (meaning neither meaningful shrinkage nor meaningful growth of tumours was detected), and none were recorded in the other response categories. The bone scan results recorded 2 participants with stable disease and 2 in another category, though the specific category label was not clearly reported in the data. No MRI response data was reported. As a secondary outcome, 3 deaths were recorded by the end of the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02260817 · results posted 17 December 2019
According to the results reported on ClinicalTrials.gov, this trial involved two groups of men with prostate cancer. The first group had 14 participants and focused on staging recurrent prostate cancer using a specialised scan called an 11C-choline PET/CT scan (a type of imaging that uses a mildly radioactive substance to highlight areas of concern in the body). The second, larger group had 95 participants enrolled, of whom 58 completed the study, and was designed to compare how well this PET/CT scan performed alongside standard CT and MRI imaging scans in detecting whether prostate cancer had spread to other parts of the body (metastatic cancer). The primary outcomes were only measured and reported for the second group. The reported data shows that, among the second group's participants, 36 had confirmed evidence that cancer had spread, 10 did not (true negatives), 11 had scans suggesting cancer spread but this was not confirmed (false positives), and 1 had a negative scan but cancer spread was later confirmed (a false negative). Based on these numbers, the reported data shows the scan correctly identified positive cases 97.29% of the time (called "sensitivity" — meaning how often the scan picked up cancer that was truly there). It correctly identified negative cases 47.61% of the time (called "specificity" — meaning how reliably a negative scan ruled out cancer spread). When a scan came back positive, there was a reported 76.59% probability that cancer spread was genuinely present, and when a scan came back negative, there was a reported 90.90% probability that cancer spread was genuinely absent. No outcome data was reported for the first group. The reported data also shows that, looking at participants whose imaging results were compared against confirmed cancer findings, 11 had positive scans with confirmed cancer, 6 had positive scans without confirmation, 11 had negative scans with confirmed cancer, and 8 had negative scans without confirmation — though the full context of how these specific figures relate to the broader results was not explained in detail in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02470910 · results posted 27 November 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants, all of whom completed the study. It was looking at prostate radiation therapy planning, specifically comparing two different medical imaging methods — MRI (magnetic resonance imaging) and CT (computed tomography) scans — to see whether the type of scan used to plan the radiation treatment made a difference to how much radiation reached nearby organs, namely the rectum and bladder. The reported data shows that for the primary measure — the volume of the rectum exposed to a high radiation dose (70 Gray or more, a unit used to measure radiation) — the MRI-planned approach was associated with a reported figure of 4.9 cubic centimetres, compared with 9.3 cubic centimetres for the CT-planned approach. For the secondary measure — the volume of the bladder exposed to the same high radiation dose — the reported figures were 9.6 cubic centimetres for MRI-based planning and 12.7 cubic centimetres for CT-based planning. In both cases, the MRI-planned group had lower reported volumes of these organs exposed to the high-dose radiation zone. It is important to note that these figures are simply measurements of radiation exposure to surrounding organs as calculated during treatment planning — they do not, on their own, indicate anything about treatment outcomes, side effects, or what is best for any individual person. The trial involved only 15 participants, which is a small number. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01683994 · results posted 8 November 2019
According to the results reported on ClinicalTrials.gov, this trial involved 45 people in total across five groups. It was a two-part study in people with prostate cancer. The first part (Phase I, 19 participants across three groups) tested different doses of a combination of three medicines — cabozantinib, docetaxel, and prednisone — to find the highest dose that could be given without too many serious side effects. The second part (Phase II, 26 participants across two groups) compared that combination against docetaxel and prednisone alone, with the main goal of measuring how long participants went without their disease getting worse (called "progression-free survival"). The reported data shows that the highest dose judged acceptable in the first part of the trial was 40 mg of cabozantinib. For progression-free survival — the length of time before the disease was recorded as getting worse — the reported figures were: 8 months for the lowest-dose combination group, 13 months for the middle-dose group, and 6 months for the highest-dose group in Phase I. In the Phase II comparison, the docetaxel-and-prednisone-only group reported 10 months, while the group receiving all three medicines reported 6.5 months. The reported data also shows that all participants who received treatment were counted as having experienced at least one adverse event (an unwanted medical occurrence), serious or otherwise. Regarding PSA levels — a protein measured in the blood that can indicate prostate cancer activity, with a normal level being 4 ng/ml or lower — the reported data shows that in Phase II, 10 out of 13 participants in the three-medicine group had a drop in PSA of at least 30%, and 9 out of 13 had a drop of at least 50%, compared with 5 out of 12 and 3 out of 12 respectively in the two-medicine group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02200614 · results posted 29 October 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02200614) enrolled a total of 1,509 men — 955 received darolutamide (also known as BAY1841788) and 554 received a placebo (a dummy pill with no active ingredient). The trial was designed to measure how long men with prostate cancer that had not yet spread to other parts of the body (called non-metastatic castration-resistant prostate cancer) could go without their cancer spreading or dying, as well as a number of other outcomes including overall survival, pain progression, and time to chemotherapy. The reported data shows that the main outcome — called "metastasis-free survival," meaning the time from when a person joined the trial until their cancer spread or they died — was reported as approximately 40.4 months for those in the darolutamide group, compared with approximately 18.4 months for those in the placebo group. For the secondary outcome measuring time until pain got worse, the reported figures were approximately 40.3 months for the darolutamide group and approximately 25.4 months for the placebo group. For the time until participants started chemotherapy, a figure of approximately 38.2 months was reported for the placebo group, but the corresponding figure for the darolutamide group was not reported in the submitted data. For overall survival (both the early and final analyses) and time to the first serious bone-related event, the data was not reported as a specific number in the results submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01377389 · results posted 9 October 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people, all of whom received a combination of ipilimumab (an immunotherapy drug) and androgen deprivation therapy (a treatment that lowers male hormones, often used in prostate cancer). Twenty-seven participants completed the study, and three did not. The trial was primarily looking at how many participants showed signs of their disease progressing — that is, worsening — after seven months on treatment, measured through a blood marker called PSA (prostate-specific antigen). Several secondary measurements were also tracked, including immune cell activity, hormone recovery, time until disease worsened after stopping hormone treatment, reported side events, and how long participants lived overall. The reported data shows that, of the 30 participants, 6 showed signs of disease progression at the seven-month mark, while 18 did not progress at that point. On the secondary measures, the reported data shows that a minimum of 55 so-called "clonal expansions" of immune cells (a measure of how active a particular type of immune cell became) were recorded. On average, testosterone levels (male hormone) recovered to a specified threshold in about 3.4 months. After stopping the hormone treatment, the reported time until disease progression was around 8 months on average. In terms of reported events considered related to the study drugs, there were 113 classified as mild, 55 as moderate, and 25 as severe — noting that severe here means medically significant but not described as immediately life-threatening. The reported overall survival figure was 36 months on average. It is worth noting that this was a single-group study with no comparison group, so all figures reflect only the people who received the combination treatment. The reported data shows numbers for this specific group of 30 participants only, and no conclusions about how these results might apply more broadly can be drawn from this data alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02268175 · results posted 8 October 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02268175) enrolled 75 men with prostate cancer across two groups. Fifty participants received a combination of four medicines — enzalutamide, abiraterone, prednisone, and leuprolide — while 25 participants received two medicines — enzalutamide and leuprolide. All 75 participants completed the study. The trial was measuring what happened to the cancer tissue removed during prostate surgery after participants had received these drug treatments beforehand, focusing on how much (if any) cancer remained in the removed tissue. The reported data shows that, for the primary goal — looking at the proportion of participants whose removed tissue showed either no detectable cancer cells at all (called a "pathologic complete response") or only a tiny amount of remaining cancer (the largest area no bigger than half a centimetre, called "minimal residual disease") — 30% of participants in the four-drug group and 16% in the two-drug group met this combined measure. Looking at the "no detectable cancer cells" result on its own, the reported data shows this occurred in 5 participants in the four-drug group and 2 participants in the two-drug group. The reported median lowest PSA blood-marker level reached during treatment was 0.03 ng/mL in the four-drug group and 0.02 ng/mL in the two-drug group. For surgical margin status (whether cancer cells were found at the edges of the removed tissue), 41 participants in the four-drug group and 22 in the two-drug group had no cancer cells at the margins, while 9 and 3 participants respectively did have cancer cells at the margins. The residual cancer burden — a measure of how much tumour tissue remained — was reported as a median of 0.03 cm in the four-drug group and 0.05 cm in the two-drug group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01419717 · results posted 9 September 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01419717) enrolled 129 participants, all of whom were in a single group that received the medicine denosumab (128 actually received it). The trial was primarily measuring how many participants experienced adverse events — that is, any unwanted medical occurrences during the study, regardless of whether they were thought to be caused by the medicine. A secondary measure looked at whether participants developed antibodies (proteins the body can produce in response to a foreign substance) against denosumab in their blood. The reported data shows that out of 128 participants who received denosumab, 98 experienced at least one adverse event of any kind. Breaking this down by severity (using a standard grading scale where Grade 1 is mild and Grade 5 means death related to the event): 45 participants had a Grade 1 event, 28 had a Grade 2 event, 22 had a Grade 3 event, 18 had a Grade 4 event, and 0 had a Grade 5 event. When looking only at adverse events the investigators thought may have been related to the medicine itself, the reported data shows 46 participants experienced at least one such event — 26 at Grade 1, 10 at Grade 2, 18 at Grade 3, 16 at Grade 4, and 8 at Grade 5. It is worth noting that only 4 participants completed the study, with 125 not completing it, though the reasons for not completing were not detailed in the data provided here. For the secondary measure, the reported data shows that 0 out of the participants tested were found to have developed anti-denosumab binding antibodies by the end of the study. It should also be noted that the structured data provided does not include the total number of participants tested for antibodies, so the full context of that figure is not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01322490 · results posted 8 August 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01322490) enrolled 1,297 men across three groups to test a vaccine-based treatment called PROSTVAC-V/F-TRICOM for prostate cancer. One group received the vaccine together with a placebo (instead of an additional drug called GM-CSF), a second group received the vaccine plus GM-CSF, and a third group received a placebo only. The main thing the trial was measuring was overall survival — that is, how long participants lived after joining the trial. The reported data shows that median overall survival (the point at which half the participants in a group had died) was 34.4 months in the vaccine-plus-placebo group, 33.2 months in the vaccine-plus-GM-CSF group, and 34.3 months in the placebo-only group. In other words, the reported survival figures were very similar across all three groups. A secondary measure looked at how many people in each group were still alive and had not experienced certain setbacks — such as their cancer spreading further, significant pain needing strong medication, starting chemotherapy, or dying — at the six-month mark. The reported data shows 127 participants met that standard in the vaccine-plus-placebo group, 121 in the vaccine-plus-GM-CSF group, and 131 in the placebo-only group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02582749 · results posted 9 July 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02582749) enrolled a total of 16 participants — 5 in the Control Arm A and 11 in the Experimental Arm B. The trial was set up to measure several things, including how long participants went without their cancer progressing on scans (called "radiological progression-free survival"), certain side effects, the time until bone-related complications occurred, the development of new cancers, and PSA levels (a protein in the blood often monitored in prostate cancer) after a period of hormone therapy. The reported data shows that no numerical results were provided for any of the outcome measures — neither the primary measure nor any of the six secondary measures. This means that while the trial recorded what it intended to measure, the actual figures for all outcomes were not submitted to ClinicalTrials.gov. It is also worth noting that none of the 16 participants were recorded as having completed the study, with all 16 listed under "not completed," though no further explanation for this is provided in the data. Because no outcome numbers were reported for any measure, it is not possible to describe what the trial found about radiological progression, side effects, bone complications, new cancers, or PSA responses. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01306890 · results posted 7 June 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,976 men with advanced or metastatic (spread beyond the original site) prostate cancer, all of whom received a treatment called sipuleucel-T. The trial was designed to measure two main things: how often participants experienced cerebrovascular events (CVEs — meaning events affecting blood flow to the brain, such as stroke), and how long participants survived overall. Of the 1,976 who started, 457 completed the study, and 1,519 did not complete it (the reasons for not completing were not detailed in the reported data). The reported data shows that the rate of cerebrovascular events was 1.2 events per 100 patient-years. "Patient-years" is a way of accounting for the fact that different people were followed for different lengths of time — in simple terms, it combines the number of participants and how long each was monitored. A rate of 1.2 per 100 patient-years means that, across all the time participants were followed, roughly 1 to 2 such events were recorded for every 100 person-years of observation. For the secondary outcome, the reported data shows a median survival time of 30.7 months. "Median" means that half of the participants survived longer than this figure and half survived for a shorter time. These numbers reflect what was observed and recorded in this particular group of participants under the conditions of this study. No comparison group (such as a placebo group) was included in the reported results, so these figures describe the sipuleucel-T group alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02043678 · results posted 5 March 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02043678) enrolled 806 people in total — 401 in the group receiving Radium-223 Dichloride combined with abiraterone/prednisone, and 405 in the group receiving a placebo combined with abiraterone/prednisone. The trial was measuring several time-based outcomes in people with prostate cancer that had spread to the bones, including how long before certain serious bone-related events occurred, how long people lived overall, and how long before pain or disease worsened. It is worth noting that the reported data shows zero participants were recorded as having "completed" the study in the conventional sense, meaning all participants either experienced an event or left the study before its end. The reported data shows that for the main outcome — the time until a serious bone-related event or death — the Radium-223 group had a reported median (the midpoint value for the group) of 22.3 months, compared with 26.0 months in the placebo group. For overall survival, the reported median was 30.1 months in the Radium-223 group and 34.8 months in the placebo group. For the time until scans showed disease progression or death, the figures were 11.2 months and 12.4 months respectively. The time until pain worsened was reported as 14.4 months for the Radium-223 group and 18.7 months for the placebo group, and the time until opiate pain medicines were needed was 19.0 months versus 22.6 months. The reported data also shows that the time until chemotherapy was started was 29.5 months in the Radium-223 group and 28.5 months in the placebo group — the only outcome where the numbers were closer together and where the Radium-223 group's figure was slightly higher. Across all the time-based outcomes reported, the placebo-combination group's figures were the same or higher than the Radium-223-combination group's figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01193257 · results posted 19 December 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,099 people with prostate cancer — 365 in a group receiving a placebo (an inactive substance) plus prednisone (a steroid), and 734 in a group receiving orteronel (an investigational drug) plus prednisone. The trial was primarily measuring how long participants lived overall, and also tracked a number of secondary measures including how long before the cancer showed signs of spreading further on scans, whether a specific protein in the blood linked to prostate cancer (called PSA) dropped by at least half, whether participants experienced less pain, and how many participants experienced side effects during treatment. The reported data shows that the median overall survival — meaning the point at which half the participants in each group had passed away — was 15.3 months in the placebo plus prednisone group and 17.1 months in the orteronel plus prednisone group. For the secondary measure of how long before the cancer appeared to progress on imaging scans, the reported figures were 5.7 months for the placebo group and 8.3 months for the orteronel group. Regarding the PSA blood marker dropping by at least 50% by week 12, the reported data shows this occurred in 9.9% of participants in the placebo group and 24.9% in the orteronel group. For pain response at week 12, the figures were 9.0% and 12.1% respectively. The number of participants who reported one or more treatment-related side effects was 345 out of 363 treated in the placebo group, and 719 out of 732 treated in the orteronel group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01972217 · results posted 2 October 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01972217) enrolled people with prostate cancer and was run in two parts. Part A was an open-label safety phase involving 16 participants (3 in a lower-dose group and 13 in a higher-dose group) who received the drug olaparib combined with abiraterone. The purpose of Part A was to check for serious side effects and find a safe dose to carry forward. Part B was a larger, randomised, double-blind phase (meaning neither participants nor investigators knew who received which treatment) involving 142 participants — 71 received olaparib combined with abiraterone, and 71 received a placebo (a dummy pill) combined with abiraterone. The main thing measured in Part B was how long it took for the cancer to show signs of growing or spreading on medical scans, known as radiological progression-free survival (rPFS). The reported data shows that in Part A, 2 out of 3 participants in the lower-dose group and 4 out of 13 in the higher-dose group experienced what the trial defined as a "dose-limiting toxicity" — meaning a side effect serious enough to potentially limit the dose that could be given. Regarding adverse events (any unwanted medical occurrence) in Part A, 66.7% of participants in the lower-dose group and 46.2% in the higher-dose group were reported to have experienced some form of adverse event. For Part B, the reported data shows that the median time before cancer progression or death was 13.8 months in the olaparib-plus-abiraterone group, compared with 8.2 months in the placebo-plus-abiraterone group. The reported data also shows that 64.8% of participants in the olaparib combination group had a progression event or died during the study period, compared with 76.1% in the placebo combination group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01519414 · results posted 12 September 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 78 participants in total — 52 people received a drug called tivantinib, and 26 received a placebo (a dummy treatment with no active ingredient). Of the placebo group, 12 people later crossed over to receive tivantinib. The trial was measuring how long people went without their cancer growing or spreading (called "progression-free survival"), as well as tracking changes in a prostate cancer marker in the blood known as PSA, and looking at how many people showed a measurable response to treatment. The reported data shows that, for the main measure, people in the tivantinib group went a median (meaning the middle value across all participants) of 5.5 months before their disease progressed, compared with 3.7 months in the placebo group. For PSA levels in the blood, the reported data shows an average percentage change from the starting level of 140.1% in the tivantinib group and 301.5% in the placebo group — meaning PSA levels rose in both groups over the course of the trial. The proportion of participants recorded as having a measurable response was reported as 1.9% in the tivantinib group, 0% in the placebo group, and 8.3% among those who crossed over from placebo to tivantinib. Regarding serious side events (graded at level 3, 4, or 5 on a standard medical scale), the reported numbers were small across all groups, though the full breakdown by event type was not presented in a way that allows complete reporting here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01496157 · results posted 28 August 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 13 men who had been diagnosed with prostate cancer confirmed by biopsy. All 13 participants completed the study — none dropped out. The trial was looking at whether a specialised type of scan called a PET scan, using a radioactive tracer called 18F-DCFBC, could detect prostate cancer in the prostate gland and also spot whether the cancer had spread to bones or lymph nodes. The PET scan results were then compared against tissue samples taken during surgery to remove the prostate. The reported data shows that for the primary goal — detecting cancer in the prostate itself — 6 out of 13 participants had a positive result on the DCFBC PET scan (meaning the scan picked up activity in the prostate), while 7 out of 13 had a negative result (meaning the scan did not pick up activity). These numbers were compared against the surgical tissue analysis to assess how well the scan performed, though the detailed comparison figures are not broken down further in the submitted data. For the secondary goal — checking whether the scan could detect cancer that had spread to bones or lymph nodes compared to standard imaging methods such as bone scans, CT, and MRI — no results figures were reported in the submitted data, so those outcomes cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02279862 · results posted 19 July 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02279862) enrolled 53 people with prostate cancer, split into two groups: 26 received a lower dose of ipilimumab (3 mg/kg) and 27 received a higher dose (10 mg/kg). The trial was mainly measuring how long participants went without their cancer showing signs of spreading on scans — called radiographic progression-free survival. It also tracked a number of secondary measures, including overall survival, changes in a prostate cancer blood marker called PSA, pain progression, and the occurrence of immune-related side effects (unwanted reactions caused by the immune system being activated). It is important to note that the study was terminated early, and the trial's own records state that the results are based on limited data as a result. The reported data shows that, for the primary measure, 4 participants in the lower-dose group and 3 in the higher-dose group had confirmed signs of cancer progression on scans. For overall survival, 4 deaths were reported in the lower-dose group and 6 in the higher-dose group. Regarding the PSA blood marker, 4 participants in the lower-dose group and 3 in the higher-dose group showed PSA progression; and a PSA response (a drop of 50% or more) was reported in 0 participants in the lower-dose group and 1 in the higher-dose group. Pain progression was reported in 0 participants in the lower-dose group and 1 in the higher-dose group. For immune-related side effects of any severity, 13 participants in the lower-dose group and 18 in the higher-dose group experienced them. Because the study ended early, timing data (such as how long before progression occurred) was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00483561 · results posted 17 July 2018
According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two medicines — gefitinib and etoposide — in people with prostate cancer. A total of 26 participants were enrolled, and 15 completed the study, while 11 did not finish. The trial was primarily measuring the "overall response rate" — that is, the proportion of participants whose cancer showed a partial or complete response (meaning it shrank or disappeared) according to two sets of standard criteria: one based on tumour imaging (called RECIST) and one based on a prostate-specific blood marker (PSA). The reported data shows that, across the two response criteria measured, 5 participants showed a response under one set of criteria, and 1 participant showed a response under the other. The trial had a pre-set rule built in: if at least 1 response was seen, 7 additional patients would be enrolled, and if 4 or more responders were found overall, the combination would be considered worth studying further. The reported numbers suggest these thresholds were being assessed, though the data as submitted does not provide a breakdown of exactly how the totals were reached across all participants. For the secondary outcome — which involved looking at biological markers (measurable substances in the body that might give extra information about how the treatment was working) — the reported data shows no measurements were submitted to ClinicalTrials.gov, so those results are not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02023697 · results posted 12 July 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 391 people in total — 130 in each of three groups — all of whom had cancer that had spread to the bones. The trial was testing a radioactive medicine called radium-223 dichloride, comparing different doses and different numbers of injections: a standard dose given 6 times (Arm A), a higher dose given 6 times (Arm B), and the standard dose given 12 times (Arm C). The main thing the trial was measuring was called "symptomatic skeletal event-free survival" — that is, how long participants went before experiencing a significant bone-related problem (such as a bone fracture, spinal cord compression, needing radiation to the bones, or needing bone surgery) or death, whichever came first. The reported data shows the following figures for that main measurement. When comparing the higher-dose 6-injection group (Arm B) against the combined standard-dose groups (Arms A and C pooled together), the median time before a bone event or death was reported as 12.9 months for the higher-dose group and 12.3 months for the standard-dose group. When comparing the standard 6-injection group (Arm A) against the 12-injection group (Arm C) — measuring from the point of the sixth dose — the reported figures were 13.2 months for Arm A and 10.8 months for Arm C. Looking at all three groups separately from the start of the trial, the reported median times were 13.1 months for Arm A, 12.9 months for Arm B, and 9.6 months for Arm C. The number of participants who reached a bone event or death during the study ranged from 40 to 92 depending on the comparison being made. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01946204 · results posted 19 June 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01946204) enrolled 1,207 participants in total — 401 people received a placebo and 806 received a medicine called apalutamide. The trial was designed for people with prostate cancer that had not yet spread to other parts of the body (called non-metastatic castration-resistant prostate cancer). The main thing the trial set out to measure was "metastasis-free survival" — that is, how long participants went without their cancer spreading to distant parts of the body or dying from any cause, whichever came first. The reported data shows that for the primary measure (metastasis-free survival), the median time — meaning the point at which half the group had experienced the event — was approximately 16.2 months in the placebo group and 40.5 months in the apalutamide group. For the secondary measure of how long until cancer first showed up on a scan in a new location (time to metastasis), the reported median was around 16.6 months for the placebo group and 40.5 months for the apalutamide group. For progression-free survival — meaning how long until the cancer visibly grew or a participant died — the reported median was approximately 14.7 months for the placebo group and 40.5 months for the apalutamide group. For overall survival (time from the start of the trial until death from any cause), the reported median was 39.0 months in the placebo group; a median figure for the apalutamide group was not reported in the data. The time to symptomatic progression and time to starting chemotherapy were also not reported as calculable figures in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01521949 · results posted 6 June 2018
According to the results reported on ClinicalTrials.gov, this trial involved 21 participants, all of whom were given acai juice. All 21 people who started the trial completed it. The trial was looking at two things related to PSA — a protein measured in the blood that is commonly monitored in people with prostate cancer. Specifically, it was measuring whether PSA levels dropped significantly, and whether the rate at which PSA was rising slowed down over time. The reported data shows that when it came to the main (primary) outcome — whether a participant's PSA level fell by at least 50% from where it started — only 1 out of 21 participants met that threshold. For the second (secondary) outcome, the trial tracked something called "PSA doubling time," which simply means how long it takes for a person's PSA level to double. The reported data shows that 15 out of 21 participants had an increase in their PSA doubling time compared to before they started — meaning their PSA appeared to be rising more slowly. It is important to note that this describes a count of participants, not a conclusion about why the change occurred. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01522443 · results posted 23 May 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01522443) enrolled 119 people with prostate cancer — 61 in the cabozantinib group and 58 in the mitoxantrone/prednisone (a chemotherapy and steroid combination) group. The trial was measuring pain response, changes visible on bone scans, and how long participants lived overall. Only 8 people in the cabozantinib group and 3 in the mitoxantrone/prednisone group were recorded as completing the study, with the majority in both groups not completing it. The reported data shows that for the primary outcome — a meaningful reduction in pain at Week 6 that was still present at Week 12, without needing more pain-relief medication — 15% of people in the cabozantinib group and 17% in the mitoxantrone/prednisone group met this measure. For one of the secondary outcomes, bone scan response (a reduction of at least 30% in the area of cancer seen on bone scans), 31% of the cabozantinib group and 5.2% of the mitoxantrone/prednisone group were reported as responding. For overall survival — meaning the middle point (median) of how long participants lived from when they entered the trial — the reported figure was 9.0 months for the cabozantinib group and 7.9 months for the mitoxantrone/prednisone group. It is worth noting that the survival data was collected at an early stage, after only about 40% of the deaths needed for the trial's full planned survival analysis had occurred. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02958787 · results posted 5 March 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02958787) enrolled 135 participants, all of whom completed the study with no drop-outs. The trial had a single group — everyone received the intervention — and there was no comparison group. The study was focused on measuring erectile function in men after radiation therapy for prostate cancer, specifically looking at whether participants were still able to be sexually active (either with or without the use of aids such as medication) following their treatment. The reported data shows that the primary outcome was measured using a simple three-level questionnaire. Participants rated themselves as: (1) sexually active without aids, (2) sexually active with aids, or (3) not sexually active at all. A score of 1 or 2 was counted as "erectile preservation." According to the results reported on ClinicalTrials.gov, 88% of participants scored either a 1 or a 2 on this questionnaire — meaning they reported being able to be sexually active in some way after radiation therapy. No breakdown between those who needed aids and those who did not was included in the reported figures. It is worth noting that because there was only one group in this trial and no comparison group, the reported figure of 88% reflects only what was observed in this particular group of participants. No secondary outcome measure data appears to have been reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00779402 · results posted 29 January 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT00779402) enrolled 176 men in total — 117 in the sipuleucel-T group and 59 in a control group. The trial was measuring "time to biochemical failure," which means how long it took for a blood marker called PSA (prostate specific antigen) to rise to a certain level (3 ng/mL or above). A rise in PSA to that level was used as a signal that the disease may have progressed. Participants were followed through a treatment phase, a surveillance phase, and a long-term follow-up phase. The reported data shows the PSA rise was tracked at different time points, expressed as the number of months by which half the participants in each group had reached that PSA threshold. At the 25th percentile mark (meaning the point at which one quarter of participants had reached the PSA threshold), the sipuleucel-T group reached it at 7.6 months compared with 6.8 months in the control group. At the 50th percentile (half of participants), the figures were 14.9 months versus 12.4 months. At the 75th percentile (three quarters of participants), the figures were 22.9 months for sipuleucel-T and 24.6 months for the control group. The reported data also shows that 85 out of 117 participants in the sipuleucel-T group and 45 out of 59 in the control group met the biochemical failure threshold during the trial. It is worth noting that no secondary outcome measure data appears to have been reported in the structured results submitted to ClinicalTrials.gov for this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01253642 · results posted 11 December 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 11 people, all of whom had castration-resistant prostate cancer (a form of prostate cancer that continues to grow despite hormone-lowering treatment) and were receiving a combination of two medicines — phenelzine and docetaxel. The trial was primarily looking at whether this combination caused a meaningful drop in PSA, a protein measured in the blood that is commonly tracked in prostate cancer. Six of the 11 participants completed the study, and five did not. The reported data shows that, for the main outcome, 2 out of 11 participants had their PSA level fall by at least 30% within 12 weeks (confirmed by a follow-up blood test at least three weeks later). For one secondary outcome, the average time before the disease showed signs of progressing — meaning getting worse by PSA levels, measurable tumour growth, or other clinical signs — was reported as approximately 78 days across participants. The reported data also shows that 8 of the 11 participants had high levels of a protein called MAOA (an enzyme found in tumour tissue) in their cancer biopsies. The maximum change in PSA across the 12-week period was reported as an average of 14.24% — though the data does not indicate in which direction (rise or fall) this average sits. Two further secondary outcomes — relating to measurements in circulating tumour cells — were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00736645 · results posted 28 November 2017
According to the results reported on ClinicalTrials.gov, this trial involved 55 men in total, split across four groups. Each group received a different combination of two supplements — finasteride (a medication) and selenium (a mineral) — or placebo versions of one or both. The trial was measuring two things: levels of a protein in the blood called PSA (prostate-specific antigen, a marker sometimes used in prostate health monitoring), and a measure of cell death in prostate tissue called apoptosis (a natural process where cells break down and die). The four groups were: finasteride plus a selenium placebo; finasteride plus selenium; two placebos; and a finasteride placebo plus selenium. Most participants completed the trial, with two people in the finasteride plus selenium group not completing it; the data does not report the reasons why. The reported data shows that PSA levels (measured in ng/mL, a standard unit of concentration) were very similar across all four groups at the end of the trial. The double-placebo group recorded a median PSA of 2.0 ng/mL, while the finasteride-only group recorded 1.9 ng/mL, the finasteride-plus-selenium group also recorded 1.9 ng/mL, and the selenium-only group recorded 2.1 ng/mL. For the secondary measure — the percentage of prostate cells undergoing that natural cell-death process — the reported data shows figures of 0.1% for the finasteride-only group and 0% for all other three groups. No additional statistical detail (such as whether these differences were considered meaningful) was included in the data as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00466752 · results posted 22 November 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled a very small number of participants — 5 people in the "48 Hour Drug Stop Point" group, and no participants at all in the "24 Hour Drug Stop Point" group. All 5 participants in the first group completed the study. The trial was looking at prostate cancer patients before surgery, and was measuring two main things: changes in gene activity in prostate cancer tissue (using a laboratory method called microarray analysis, which reads many genes at once), and whether a protein linked to prostate cancer called PSA dropped in the blood after treatment. The reported data shows that for the primary outcome — changes in gene activity and complete disappearance of cancer from tissue samples — no numbers were recorded or submitted to ClinicalTrials.gov for either group. For the secondary outcomes, the reported data shows that none of the 5 participants in the 48 Hour group had their PSA drop by at least 50% at either of the two earlier measurement points or on the day of surgery. When looking at a smaller drop of at least 25%, the reported data shows that 0 participants met this threshold at the first two time points, but 1 out of the 5 participants did reach a 25% or greater PSA reduction by the day of surgery. No data was reported for the "24 Hour Drug Stop Point" group for any of these measures. It is worth noting that because only 5 people took part and one entire group had no participants, the numbers reported here are very limited in scope. The reported data shows only what was observed in this small group, and the primary outcome data was not reported at all. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01718353 · results posted 20 November 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01718353) enrolled 63 people with prostate cancer across two groups: 41 started on a medicine called docetaxel plus prednisone (Treatment A), and 22 started on cabazitaxel plus prednisone (Treatment B). The trial was measuring how well a "switch" approach worked — where patients who did not show a meaningful drop in a prostate cancer blood marker (called PSA) after four treatment cycles were moved to the other medicine. Because the focus was on this switching strategy overall, most of the results were reported for all participants combined rather than separately by group. The reported data shows that for the primary outcome — the proportion of participants whose PSA level fell by 50% or more — the combined results showed three separate figures were recorded (likely reflecting different time points or sub-groups within the overall population): 39.7%, 15.9%, and 55.6% of participants, though the data as reported does not clearly label which figure corresponds to which specific time point or sub-group. For the second co-primary outcome, which looked at a biological marker in circulating tumour cells (cells shed from the tumour into the blood), participants whose PSA dropped by 50% or more showed an average change of −17.58 percentage points in a measure of how a particular protein behaved inside tumour cells, compared to a change of +2.30 percentage points in those who did not reach that PSA drop. For the secondary outcomes, the reported median time before the disease progressed (got worse) was 4.1 months before any treatment switch and 9.1 months across the whole study period. The median time before PSA specifically progressed during the study was reported as 12.4 months (the figure before any switch was listed as not available). The data for objective tumour response rate and radiographic progression-free survival were not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01995513 · results posted 17 November 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01995513) involved men with prostate cancer and was conducted in two main phases. In the first phase, 509 participants received enzalutamide on its own. Of those, 126 later moved into a double-blind phase (meaning neither the participants nor their doctors knew which treatment group they were in) where they received enzalutamide combined with abiraterone and prednisone, while 125 others received a placebo (inactive substitute) combined with abiraterone and prednisone. The trial was primarily measuring how long participants went without their disease getting worse — known as progression-free survival. The reported data shows that for the main outcome, the median time before disease progression was 5.7 months in the enzalutamide-plus-abiraterone-and-prednisone group, compared with 5.6 months in the placebo-plus-abiraterone-and-prednisone group. For the secondary outcomes, the median time before a specific blood marker for prostate cancer (PSA) worsened was 2.8 months in both groups. The proportion of participants whose PSA levels dropped by 50% or more was reported as approximately 2.4% in the combination group and 2.5% in the placebo group. Regarding tumour response, 0% in the combination group and 5% in the placebo group showed a measurable reduction in tumour size. Pain progression was reported in 36.2% of participants in the combination group and 27.1% in the placebo group. The median time before participants needed a new cancer treatment was 10.3 months in the combination group and 8.6 months in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01717391 · results posted 5 September 2017
According to the results reported on ClinicalTrials.gov, 36 people took part in this trial, of whom 27 completed it and 9 did not. The trial was looking at whether a specialised type of radiation planning — one designed to reduce the amount of radiation hitting active bone marrow (the spongy tissue inside bones that produces blood cells) — could spare more bone marrow compared to a standard radiation plan. To identify where active bone marrow was located in each person, researchers used a special type of scan called an FLT PET/CT scan before treatment began. The reported data shows that, for the main thing being measured, the bone-marrow-sparing radiation plan delivered less radiation to active bone marrow than the standard plan across all dose levels tested. The reported percentage differences ranged from about −4.7% at the lowest radiation dose level (5 Gray) up to around −14.2% at 20 Gray, with −13.4% at 30 Gray. A negative number here means the bone-marrow-sparing plan exposed less bone marrow to radiation compared to the standard plan. The reported difference in radiation dose reaching the tumour itself was very small, at −0.1%. For the secondary measures, the reported data shows that 7 out of 27 participants had their chemotherapy (drug treatment) held back at least once because their blood counts were too low. For white blood cell, platelet, and neutrophil counts recorded during and after treatment, all 27 participants were recorded at the lowest severity grade (Grade 0 or Grade 1) during the treatment period, with the exception of 2 participants who recorded a slightly higher grade for neutrophil counts and lymphocyte counts at the one-year follow-up point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00377156 · results posted 24 August 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 213 people with one to three brain tumours that had spread from cancer elsewhere in the body (known as brain metastases). Participants were split into two groups: 111 people received a targeted radiation treatment called stereotactic radiosurgery (SRS) on its own, and 102 people received SRS combined with whole-brain radiation therapy (WBRT), which treats the entire brain. The trial was primarily measuring whether participants experienced a decline in thinking and memory skills (called cognitive deterioration) by three months after treatment. The reported data shows that, for the primary measure at three months, 40 out of the SRS-only group and 44 out of the SRS-plus-WBRT group showed a measurable decline in at least one thinking or memory test. For a secondary measure looking at tumour control up to three months, 79 participants in the SRS-only group and 89 in the combined group were recorded as having local and distant tumour control. The reported data also shows that quality-of-life scores (measured on a 0–100 scale, where higher is better) changed by an average of −0.1 points in the SRS-only group and −12 points in the combined group from the start of the trial to three months. Among those who survived at least 12 months, 60% in the SRS-only group and approximately 94% in the combined group were recorded as showing cognitive deterioration. For overall survival, the reported median survival time (the point at which half the group had passed away) was 10.4 months in the SRS-only group and 7.4 months in the combined group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00572468 · results posted 13 July 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 42 men — 22 in the simvastatin group and 20 in the placebo group — who were scheduled to have their prostate surgically removed. The trial was measuring two things in prostate tissue collected during surgery: the activity of a protein called the Androgen Receptor (AR), which plays a role in prostate cell behaviour, and the level of cell death (called apoptosis) in prostate cancer cells, measured using a marker called Ki67 staining. For the main (primary) outcome, the reported data shows that AR activity — expressed as a percentage of cells showing the marker — was measured at approximately 168.7% in the simvastatin group and approximately 182.7% in the placebo group. For the secondary outcome, the reported data shows that the Ki67 cell-staining percentage, used as a measure of cell activity related to apoptosis, was approximately 7.5% in the simvastatin group and 6.0% in the placebo group. These numbers are the averages reported for each group; no further statistical comparison data (such as whether the difference between groups was considered meaningful) was reported in the submitted results. It is worth noting that of the 42 men who started the trial, 36 completed it — 20 in the simvastatin group and 16 in the placebo group. The reported results reflect the measurements taken from tissue at the time of surgery, and no additional outcome data beyond these figures was included in the submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02116582 · results posted 8 June 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 215 people, all of whom received a drug called enzalutamide. The trial was designed for people with a type of prostate cancer, and it was primarily measuring how long participants went without their cancer visibly growing or spreading on scans — a measure called "radiographic progression-free survival." The trial also tracked overall survival (how long participants lived), changes in a prostate cancer blood marker called PSA, and unwanted side effects. The reported data shows that, on average, participants went 8.1 months before their cancer showed visible growth on scans or they passed away — whichever came first. For overall survival (time from first dose until death from any cause), the data was not reported as a usable number at the time of analysis. Regarding the PSA blood marker, 22% of participants had their PSA level drop by at least half during the trial. The reported data also shows that, on average, it took about 5.7 months before PSA levels began rising again according to the study's definition of progression. Regarding unwanted events, the reported data shows that out of 214 treated participants, 199 experienced at least one adverse event (an unwanted or unexpected health change noted during the study). Of those, 127 experienced what were classified as more serious adverse events, and 82 experienced events considered related to the study drug. The remaining figures covered specific categories such as deaths and events leading to stopping treatment, though the labels for each individual number were not fully distinguishable in the available data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01193244 · results posted 17 May 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 779 people in the placebo-plus-prednisone group and 781 people in the orteronel-plus-prednisone group — around 1,560 participants in total. The trial was studying men with a form of prostate cancer, and it was primarily measuring two things: how long it took for the cancer to visibly progress on scans (called "radiographic progression-free survival"), and how long participants lived overall. The reported data shows that, for the scan-based progression measure, the placebo group reached a midpoint figure of 8.7 months, while the orteronel group reached 13.8 months. For overall survival — that is, how long participants lived from the start of the trial — the reported midpoint figures were 29.5 months for the placebo group and 29.9 months for the orteronel group. Turning to the secondary measures: at week 12, about 24.6% of placebo participants had their PSA (a protein measured in the blood that is tracked in prostate cancer) drop by at least half, compared with 42.6% in the orteronel group. A measure of circulating tumour cells showed a favourable reading in 9.1% of the placebo group and 15.4% of the orteronel group at week 12. The time-to-pain-progression figures were not reported in the data. Regarding unwanted events, 733 placebo participants and 769 orteronel participants reported at least one treatment-related adverse event, and serious adverse events were reported in 321 and 380 participants respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00331773 · results posted 13 April 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,115 people with prostate cancer — 558 in one group and 557 in the other. One group received a standard radiation treatment schedule (called "conventional 3D-CRT"), while the other received a compressed schedule delivering higher doses over fewer sessions (called "hypofractionated 3D-CRT"). The trial's main goal was to compare how many people in each group were free from signs of disease progression five years after treatment. The reported data shows that, at five years, approximately 85.3% of participants in the conventional group and 86.3% in the compressed-schedule group were free from disease progression events (which included cancer spreading, a rise in a prostate-specific blood marker called PSA, or death from any cause). For overall survival at five years, the figures were 93.2% and 92.5% respectively. The five-year rate of the cancer coming back at the original site was reported as 1.2% for the conventional group and 0.4% for the compressed-schedule group, though the trial organisers noted there were too few of these events to make a formal statistical comparison between the two groups. Death specifically linked to prostate cancer was reported at 0.2% in both groups at five years. A rise in PSA levels — used as a marker that the cancer may be returning — was recorded in 8.1% of the conventional group and 6.3% of the compressed-schedule group over that period. The reported data also tracked unwanted side effects affecting the bladder/urinary system (genitourinary) and bowel (gastrointestinal). These were measured using a standard grading system where higher grades mean greater severity. The numbers of participants experiencing side effects at various grades were reported across both acute (within 90 days of finishing treatment) and longer-term periods, with figures in each group appearing broadly similar, though the data as submitted does not break these down in a way that allows straightforward plain-English comparison of every sub-category. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01558492 · results posted 12 April 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 3 participants, all of whom completed the study with none dropping out. The trial was measuring changes in PSA levels (a protein in the blood that can be associated with prostate conditions), changes in tumour size (assessed using CT or MRI scans and/or bone scans), and changes in survival status. The reported data shows that no numerical results were provided for any of the outcome measures — not for PSA levels, tumour size, or survival status. This means that, based on what was submitted to ClinicalTrials.gov, it is not possible to describe what happened to participants across any of these measurements. It is worth noting that this was a very small study involving only 3 people, and the absence of reported numbers limits what can be understood from the submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02247960 · results posted 15 March 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 175 people in total — 85 in the ciprofloxacin (antibiotic) group and 90 in the no-antibiotic group — who had recently had surgery involving a urinary catheter. The trial was measuring whether taking the antibiotic ciprofloxacin around the time the catheter was removed made a difference to rates of urinary tract infection (UTI), the presence of bacteria in urine, and the development of a gut infection called *Clostridium difficile*, over a follow-up period of up to 12 months after the operation. The reported data shows that for the main thing being measured — the number of people who developed a confirmed UTI — 5 participants in the ciprofloxacin group and 5 participants in the no-antibiotic group tested positive. For bacteria detected in urine samples, 38 participants in each group were found to have one or more types of bacteria present. Regarding *Clostridium difficile* (a type of gut infection sometimes associated with antibiotic use), the reported data shows 0 cases in the ciprofloxacin group and 3 cases in the no-antibiotic group, though it is worth noting that the overall numbers here are small. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01308567 · results posted 3 March 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01308567) enrolled 1,168 men with prostate cancer across three groups: one group received a chemotherapy medicine called docetaxel (391 participants), and two groups received different doses of another chemotherapy medicine called cabazitaxel — a lower dose (389 participants) and a higher dose (388 participants). The trial was primarily measuring how long participants lived overall, and also tracked a number of other things including how long it took for their cancer to show signs of getting worse, how their tumours responded to treatment, and changes in a prostate-related blood marker called PSA (prostate-specific antigen). The reported data shows that for the main measure — overall survival, meaning the time from entering the trial until death from any cause — the median (the midpoint figure, where half of participants lived longer and half lived shorter) was 24.3 months for the docetaxel group, 24.5 months for the lower-dose cabazitaxel group, and 25.2 months for the higher-dose cabazitaxel group. For how long it took for the cancer to show signs of progressing in any way, the reported medians were 5.3, 4.4, and 5.1 months for the three groups respectively. When looking only at tumour shrinkage on scans, the time figures were 12.1, 13.4, and 13.1 months. The reported data shows that the percentage of participants whose tumours shrank meaningfully on scans was 30.9% in the docetaxel group, 32.4% in the lower-dose cabazitaxel group, and 41.6% in the higher-dose cabazitaxel group. For the PSA blood marker, the percentage of participants who had a large drop (at least 50%) in PSA levels was reported as 68.4%, 60.7%, and 68.7% across the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01215032 · results posted 27 February 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 21 people, all of whom received the diabetes medication metformin. The trial was looking at whether metformin had any effect on PSA (prostate-specific antigen) — a protein measured in the blood that is often monitored in people with prostate cancer. The main thing being measured was the change in PSA levels after 12 weeks of treatment. Only 1 of the 21 participants completed the study, while 20 did not finish. The reported data shows that, on average, PSA levels across participants were 161% of where they started at baseline — meaning PSA levels appeared to rise rather than fall over the course of the study. For the secondary outcome looking at a meaningful PSA drop (defined as PSA falling by at least 50% and staying down), the reported data shows that 0 out of 21 participants met this measure. The trial also looked at blood sugar control: among participants who had normal blood sugar markers at the start, 15 maintained good blood sugar control during the study; among those who had abnormal blood sugar markers at the start, 6 maintained good blood sugar control. One further secondary outcome — examining whether certain metabolic profiles in the blood could predict how someone might respond to metformin — was listed in the trial but no numerical results were reported for it in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00895310 · results posted 15 February 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people, all of whom received a medicine called ketoconazole. Twenty-nine of the 30 participants completed the study, with one person not finishing. The trial was looking at how ketoconazole affected levels of a protein called PSA (Prostate Specific Antigen) — a substance measured in the blood that is commonly tracked in people with prostate cancer — as well as how long participants went without their condition getting worse. The reported data shows that the main thing being measured was whether a participant's PSA level dropped by 50% or more from where it started. Out of 30 participants, 14 reached that level of PSA reduction. For a less strict measure — a drop of 30% or more — the reported data shows 17 participants reached that point. The trial also tracked how long participants went without signs of the disease progressing, which was reported as 138 days on average. Additionally, the length of time participants had what was described as "stable disease" (meaning the condition was neither clearly improving nor clearly worsening) was reported as 123 days on average. It is worth noting that this trial had only one group, meaning everyone received ketoconazole and there was no comparison group receiving a different treatment or a placebo (a dummy treatment). This means the numbers above describe what was observed in this one group only, without a direct comparison point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02175212 · results posted 4 November 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT02175212) enrolled 355 men with prostate cancer — 177 in a "long-term hormone therapy" group and 178 in a "short-term hormone therapy" group. Both groups also received radiation treatment. The trial was comparing two different lengths of androgen deprivation therapy (a type of hormone treatment that lowers testosterone) alongside radiotherapy, to see how participants fared over five years on measures including whether their cancer showed signs of returning through a blood marker called PSA, whether cancer spread to other parts of the body, and whether participants were still alive. The reported data shows that, at the five-year mark, an estimated 90% of participants in the long-term hormone therapy group had no biochemical relapse (no significant rise in their PSA blood test indicating possible cancer return), compared with 81% in the short-term group. For the secondary outcomes, the reported figures for estimated freedom from cancer spreading to other parts of the body at five years were 94% (long-term group) versus 83% (short-term group). The estimated percentage of participants still alive at five years was reported as 95% in the long-term group and 86% in the short-term group. For the cause-specific survival outcome, the data as reported lists participant counts of 177 and 173 respectively, but the figures were not broken down further in the submitted results. Regarding late side effects occurring more than 90 days after radiation, the reported data shows several percentage figures across rectal, urinary, and cardiovascular categories, ranging from around 7% to 18% across both groups, though the submitted results do not clearly label which specific percentage corresponds to which type of side effect. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01308580 · results posted 11 October 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,200 people in total — 598 in one group and 602 in another. Each group received a different dose of a medicine called cabazitaxel (either 20 mg/m² or 25 mg/m²). The main thing the trial was measuring was overall survival — that is, how long participants lived after being randomly assigned to their group. Several secondary measures were also tracked, including how long it took for the disease to progress, how long participants lived without their disease worsening, whether tumours shrank on scans, and changes in a prostate cancer blood marker called PSA (prostate-specific antigen). The reported data shows that, for overall survival (the primary measure), the median time — meaning the point by which half the participants in each group had died — was 13.4 months in the lower-dose group and 14.5 months in the higher-dose group. For progression-free survival (how long before the disease worsened or death occurred), the reported median figures were 2.9 months and 3.5 months respectively. When looking only at tumour progression on scans, the reported medians were 9.0 months and 9.3 months. For the PSA blood marker, the time before it showed signs of worsening was reported as 5.7 months in the lower-dose group and 6.8 months in the higher-dose group. The reported data also shows that around 18.5% of participants in the lower-dose group and 23.4% in the higher-dose group had their tumours shrink or disappear on scans. Additionally, a PSA drop of 50% or more from the starting level was reported in approximately 29.5% of the lower-dose group and 42.9% of the higher-dose group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00776594 · results posted 23 August 2016
According to the results reported on ClinicalTrials.gov, this trial involved 102 men with prostate cancer who were split into two groups: 66 received androgen deprivation therapy (ADT — a hormone-reducing treatment) plus a drug called bevacizumab, while 36 received ADT alone. The trial was measuring how long participants went without their cancer returning (called "relapse-free survival"), as well as several other things including PSA levels (a protein in the blood often monitored in prostate cancer), blood pressure changes, and levels of certain proteins in the blood. The reported data shows that, for the primary measure of relapse-free survival, the group receiving ADT plus bevacizumab had a reported median (middle value) of 13 months without relapse, compared to 10 months for the ADT-alone group. For one of the secondary measures — the number of participants whose PSA dropped below 0.2 ng/ml at six months — the reported figures were 51 out of 66 participants in the combination group and 27 out of 36 in the ADT-alone group. Regarding blood pressure monitoring, the reported data shows that 48 participants in the combination group and 13 in the ADT-alone group developed raised blood pressure during the treatment period. A blood protein measurement called leptin was also recorded, with the combination group showing an average level of 13,755 pg/ml compared to 10,179 pg/ml in the ADT-alone group; however, the clinical meaning of this difference was not explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00685516 · results posted 6 June 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 113 men with prostate cancer across three groups: 42 drinking green tea, 38 drinking plain water, and 33 drinking decaffeinated black tea. The trial was measuring whether drinking green tea or black tea in the weeks before prostate surgery might influence certain characteristics of the cancer tissue removed during surgery — specifically, levels of programmed cell death (where cells self-destruct), cell growth activity, cell oxidation (a form of cellular stress), and inflammation. The trial also looked at whether compounds from tea could be detected in the prostate tissue and urine, and measured a prostate cancer marker in the blood called PSA (prostate-specific antigen). The reported data shows that, for the tissue measurements, the percentages of cells showing these four characteristics were broadly similar across all three groups. For example, the reported figures for cell oxidation were 5.5% (green tea), 7.27% (water), and 11.23% (black tea), and for inflammation were 37.4%, 37.06%, and 37.35% respectively. When it came to detecting tea compounds directly in prostate tissue, the reported data shows measurable levels were found only in the green tea group (for example, one compound measured at 42.1 pmol per gram of tissue), while the water and black tea groups both recorded zero for those same compounds. Tea compounds in urine were also detected at higher levels in the green tea group compared to the black tea group, with none detected in the water group. The reported PSA blood levels were 8.4 ng/mL (green tea), 10.0 ng/mL (water), and 9.6 ng/mL (black tea), though the data does not report whether these differences were considered meaningful by the researchers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01867710 · results posted 11 May 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01867710) enrolled 164 men with prostate cancer across four groups, each receiving abiraterone acetate combined with a different steroid companion: prednisone 5 mg twice daily (41 participants), prednisone 5 mg once daily (41 participants), prednisone 2.5 mg twice daily (40 participants), or dexamethasone 0.5 mg once daily (42 participants). The trial was measuring whether different steroid combinations alongside abiraterone acetate led to different rates of two particular side effects — low potassium levels in the blood and high blood pressure — over the first 24 weeks. It also tracked changes in a prostate-specific blood marker (PSA), self-reported pain, and quality of life. Notably, none of the participants were recorded as having completed the study in the conventional sense, as all exits were logged under "not completed," which may reflect how the trial was structured or reported. The reported data shows that, during the first 24 weeks, the percentage of participants who experienced neither of the two monitored side effects was 70.6% in the prednisone 5 mg twice-daily group, 36.8% in the prednisone 5 mg once-daily group, 60.0% in the prednisone 2.5 mg twice-daily group, and 70.3% in the dexamethasone group. For the PSA measure — looking at whether PSA levels fell by at least half from the starting point by week 12 — the reported figures were 57.1%, 70.6%, 47.2%, and 79.5% respectively across the four groups. Changes in self-reported pain scores and a quality-of-life index were also recorded across all groups, with the numbers showing small shifts from starting values on their respective scales; the reported data does not allow a straightforward conclusion to be drawn about which group fared better or worse on these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01428219 · results posted 2 May 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 25 participants, all of whom received a drug called cabozantinib (also known as XL184). Twenty-two participants completed the study, and three did not. The trial was primarily looking at what proportion of participants showed no signs of their cancer growing or spreading (called "progression-free") after 12 weeks on the treatment. It also tracked side effects, changes in certain markers measured in blood and bone, how long any response to treatment lasted, and whether responses were seen in both soft tissue tumours and bone disease. The reported data shows that 77.3% of participants (roughly 17 out of 22 evaluable participants) had no recorded disease progression at the 12-week mark using a standard tumour measurement system. A related measure — looking at the proportion of participants alive without progression at 12 weeks — was reported as 89.5%. For responses in the disease itself, the reported data shows that around 5% of participants showed a response in soft tissue disease, while 59% showed a response in bone disease. The reported duration of those responses was approximately 9 weeks for soft tissue and 18 weeks for bone. Regarding side effects, the reported data shows a range of adverse events (unwanted health events that were recorded during the trial) across different categories, with counts varying from 1 to 78 events per category — however, the data as submitted does not label each individual category by name, so a full breakdown cannot be described here. Changes in bone metabolism markers (substances measured in blood and bone that reflect bone activity) were also reported, with the figures ranging from a fold change of −29.8 to +65.5 depending on the specific marker measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01302041 · results posted 6 April 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 67 men, all of whom received the study drug enzalutamide. The trial was measuring how their levels of PSA (prostate-specific antigen, a protein in the blood often tracked in prostate cancer care) changed over time, as well as tracking side effects and changes in several other hormones in the blood. By the end of the study, 27 participants had completed it, while 40 did not finish for various reasons. The reported data shows that the main thing being measured — the proportion of participants whose PSA level dropped by 80% or more from their starting level by week 25 — was reported as 92.5% of participants. For the broader PSA change figures, multiple percentage-change values were reported across different time points or subgroups (ranging from around -0.70% to -99.44%), though the trial record does not provide labels clearly linking each number to a specific time point, so a precise breakdown cannot be given here. Regarding side effects, the reported data shows that all 67 participants experienced at least one adverse event (an unwanted medical occurrence), 65 experienced events considered possibly or probably related to the study drug, 24 experienced a serious adverse event (a more significant medical occurrence such as one requiring hospitalisation), and 5 participants died during the study period. Changes in other hormones in the blood — including SHBG, androstenedione, and DHEA — were also recorded, with some showing increases and others small changes, though again the specific time points for each figure were not clearly labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00861614 · results posted 16 March 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 789 people with prostate cancer — 393 received ipilimumab (a type of immunotherapy) combined with radiotherapy, and 396 received a placebo (inactive treatment) combined with radiotherapy. The trial's main goal was to measure how long participants lived overall, and it also tracked how long their disease took to progress, whether their pain improved, and what unwanted health events occurred during the study. The reported data shows that the median time participants lived after joining the trial — that is, the point at which half of participants had died and half were still alive — was about 11 months in the ipilimumab group and about 10 months in the placebo group. Looking at survival rates over time, the reported data shows that at one year, approximately 46.5% of the ipilimumab group and 40.8% of the placebo group were alive; at two years, 25.2% versus 16.6%; at three years, 15.3% versus 7.9%; at four years, 10.1% versus 3.3%; and at five years, 7.9% versus 2.7%. For the secondary outcomes, the median time before the disease progressed was about 4 months in the ipilimumab group and about 3 months in the placebo group. A pain response (a meaningful reduction in pain without needing extra pain relief) was reported in approximately 3.6% of ipilimumab participants and 0.5% of placebo participants, lasting a median of about 2.5 months and 1.5 months respectively. Regarding unwanted health events, the reported data shows that serious adverse events were recorded in 296 participants receiving ipilimumab and 180 receiving placebo, and immune-related adverse events were recorded in 250 ipilimumab participants compared with 86 placebo participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00454571 · results posted 10 February 2016
According to the results reported on ClinicalTrials.gov, this trial involved 37 men with prostate cancer, split into two groups. Eighteen men received a combination of pazopanib (a targeted therapy drug) plus hormone-suppressing injections (leuprolide acetate and goserelin acetate), while 19 men received the hormone-suppressing injections only. The trial was measuring how long it took for a prostate-specific antigen (PSA) — a protein in the blood often used to monitor prostate cancer — to show signs of rising again, which researchers used as a marker of disease progression. The reported data shows that of the 37 men who started the trial, only 5 in the combination group and 13 in the injections-only group completed it. Thirteen men in the combination group and 6 in the injections-only group did not complete the trial, though the reasons for this are not detailed in the submitted data. Importantly, no numerical results were reported to ClinicalTrials.gov for either the primary outcome (median time to PSA progression) or the secondary outcome (median PSA progression-free survival time) for either group — meaning the actual measured figures were not made available in the submitted results. Because the key outcome numbers were not reported in the data submitted to ClinicalTrials.gov, it is not possible to describe what the trial found in terms of how the two groups compared. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01360840 · results posted 14 December 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01360840) enrolled 180 people with prostate cancer, divided equally into three groups of 60: one group received a placebo plus standard care, one received a lower dose (750 mg) of the experimental drug EMD 525797 plus standard care, and one received a higher dose (1500 mg) of EMD 525797 plus standard care. Around 50–51 people in each group completed the study. The trial was primarily measuring how long participants went without their disease getting worse — known as "progression-free survival" — and also tracked a number of secondary measures including overall survival, time until tumours visibly grew, and changes in bone and soft-tissue lesions. The reported data shows that the median time before disease progression (or death) was 3.3 months in the placebo group, 3.4 months in the lower-dose group, and 4.3 months in the higher-dose group. For the related measure of time until tumours objectively grew, the reported figures were 3.3 months, 3.4 months, and 4.6 months respectively. For overall survival, the data was not reported (listed as "NA" in the submitted results). Regarding soft-tissue tumour responses, very small numbers of participants showed a measurable reduction in tumour size: 1 person in the placebo group, 0 in the lower-dose group, and 1 in the higher-dose group. When looking at "disease control" in soft tissue (meaning the tumour shrank or stayed stable for at least 12 weeks), the reported numbers were 2, 3, and 4 participants respectively. New bone lesions appeared in 40 people in the placebo group compared with 34 in each of the two EMD 525797 groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00741039 · results posted 20 November 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 127 people in total — 102 adults aged 65 and older who had been diagnosed with cancer, and 25 healthy volunteers. The study was measuring how the immune systems of these two groups responded to Pneumovax, a vaccine used against pneumococcal bacteria (the kind that can cause serious lung and blood infections). Specifically, the trial looked at whether participants' bodies produced enough of a measurable immune response — called a "complete response" — after receiving the vaccine. The reported data shows that, among the cancer patient group, 63 out of 102 participants met the criteria for a complete response to the vaccine. In the healthy volunteer group, 24 out of 25 participants met that same criteria. A "complete response" in this context meant that a person either developed a detectable immune reaction for the first time (called seroconversion) or showed their existing immune response rise by more than three times its starting level, across at least five of the seven specific bacterial strains included in the vaccine. Two participants in the cancer group did not complete the study, while all 25 healthy volunteers completed it. No other outcome measures were included in the reported data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00851682 · results posted 11 November 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 65 men with prostate cancer across two groups: 60 who were scheduled for surgical removal of the prostate (called radical prostatectomy) and 5 who were receiving a type of internal radiation treatment (called brachytherapy). The trial was investigating whether MRI scans could more accurately detect prostate cancer, and whether MRI imaging could be used to guide a type of tissue sampling procedure called a transrectal ultrasound biopsy. Of the 60 surgical patients, 55 completed the study, while 5 did not finish; all 5 brachytherapy patients completed the study. The reported data shows that no meaningful numbers or measurements were able to be produced for either of the trial's stated goals. For the primary goal — improving the accuracy of prostate cancer detection using MRI — the trial team reported that the data could not be analysed in a meaningful way. This was due to difficulties matching up the cancerous tissue identified through laboratory examination of tissue samples with what was seen on the MRI images. For the secondary goal — using MRI to guide the biopsy procedure — the reported data shows that this guidance approach was never actually attempted during the trial. As a result, the reported results contain no outcome numbers for either measure. The data was not reported in a way that allows any comparison or conclusion to be drawn from the figures collected. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01511536 · results posted 4 November 2015
According to the results reported on ClinicalTrials.gov, this trial had two phases and involved a total of 37 people with prostate cancer. In Phase 1, 10 participants were enrolled — 3 received a lower dose of the drug cabazitaxel (20 mg/m²) combined with abiraterone, and 7 received a higher dose (25 mg/m²) combined with abiraterone. The goal of Phase 1 was to find the highest dose of cabazitaxel that could be given alongside abiraterone without too many participants experiencing serious side effects (called the "maximally tolerated dose"). In Phase 2, a separate group of 27 participants received the combination at the higher dose, and the main thing being measured was how many experienced a meaningful drop in a protein called PSA (prostate-specific antigen), which is a marker measured in the blood that doctors use to monitor prostate cancer. The reported data shows that in Phase 1, the highest tolerated dose of cabazitaxel in combination with abiraterone was identified as 25 mg/m². In Phase 2, the reported results show that approximately 46.2% of participants had a PSA drop of 50% or more from their starting level — which was the key measurement the trial was tracking. For a secondary measure looking at how long participants went without their cancer progressing based on PSA levels, the reported figure was around 6.93 months. Around 21.4% of participants showed a measurable shrinkage in tumours based on scan-based assessments. Two other secondary measures — overall survival (how long participants lived) and progression-free survival based on scans — were recorded as "NA" (not available), meaning those figures were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01715129 · results posted 28 October 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 126 participants, all of whom received a treatment called triptorelin pamoate, given as an injection under the skin twice over six months (approximately three months apart). The trial was measuring whether the treatment could reduce testosterone levels in the blood to a very low level — below 50 ng/dL, a threshold commonly referred to as "castration level" — and whether that reduction could be maintained over time. Of the 126 people who started, 117 completed the trial and 9 did not. The reported data shows that 97.6% of participants reached that low testosterone threshold by Day 29 (about four weeks after the first injection). Of those who reached that threshold, 96.6% were reported to still be at that level by Day 183 (approximately six months). The reported data also shows that 99.2% of participants had low testosterone levels just before their second injection (around Day 92), and 98.3% were at that level a few days after the second injection (around Day 95). A separate analysis reported that the probability of maintaining low testosterone from Day 29 through to Day 183 was 0.96 (meaning 96 out of every 100 participants, on average). The median time it took for testosterone to first drop to that low threshold was reported as 22 days. The trial also measured the amount of triptorelin remaining in the blood just before each injection; those figures were reported as 0.062 ng/mL before the second dose and 0.049 ng/mL at the end of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01650350 · results posted 27 July 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01650350) enrolled 7 participants who received low-dose naltrexone. All 7 completed the study and none dropped out. The trial was measuring how many participants with advanced melanoma (skin cancer), castrate-refractory prostate cancer (a form of prostate cancer that has stopped responding to hormone treatment), or kidney cancer showed a response to the treatment, based on a standard imaging method called RECIST — which uses CT scans and physical examinations to track whether tumours change in size over time. The reported data shows that, when looking at tumour responses, the results were broken down by cancer type. For the melanoma group, the reported numbers show 0 participants recorded across the response categories measured. For the prostate cancer group, the reported figures were 2, 6, 1, and 0 participants across those same categories — though the specific labels for each category (such as complete response, partial response, stable disease, or progression) were not clearly mapped to the measurements in the data as submitted. No data for a renal (kidney) cancer group appears in the submitted results, and any findings for that group were not reported in the structured data available. The reported data also shows that the secondary outcome — measuring how many participants experienced a serious adverse event (an unexpected or significant medical problem during the trial) — recorded 0 participants in the low-dose naltrexone group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01546623 · results posted 21 July 2015
According to the results reported on ClinicalTrials.gov, this trial involved 162 men with prostate cancer — 82 assigned to a 6-month formulation of a drug called TAP-144-SR and 80 assigned to a 3-month formulation of the same drug. The trial was mainly measuring how many participants had their testosterone (a hormone) reduced to what is called a "castrate level" — a very low level of 100 ng/dL (nanograms per decilitre) or below. Testosterone levels are commonly monitored in prostate cancer management. Around 150 of the 162 participants completed the trial (76 in the 6-month group and 74 in the 3-month group). The reported data shows that, for the primary measure, 81 out of 81 participants in the 6-month group and 78 out of 79 participants in the 3-month group had their testosterone maintained at or below that castrate level threshold. Regarding the secondary measures, testosterone blood levels at various time points across both groups were reported in the very low single digits (roughly 6–8 ng/dL). Two other hormones — LH (luteinising hormone) and FSH (follicle-stimulating hormone) — were also tracked over time; the reported values remained consistently low across both groups throughout the study. A blood marker called PSA (prostate-specific antigen, a protein sometimes monitored in prostate cancer) was also measured, and the reported data shows percentage reductions over time in both groups, with the largest reported reductions being approximately 86% in the 6-month group and 67% in the 3-month group at their respective peak points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01078662 · results posted 22 May 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 298 people across five cancer groups: 62 with breast cancer, 193 with ovarian cancer, 23 with pancreatic cancer, 8 with prostate cancer, and 12 with other cancers. The trial was measuring how tumours responded to the treatment being studied, as well as tracking how long participants lived and how long it took for their disease to progress. The number of participants who completed the full study was small in each group — for example, only 25 of the 193 ovarian cancer participants and 4 of the 62 breast cancer participants completed the study, with the remainder not completing it for reasons the data does not detail here. The reported data shows that the main measure — the proportion of participants whose tumour shrank or disappeared at least once during the study (called the "tumour response rate") — varied by cancer type. Across all participants combined, this figure was reported as 26.2%. By cancer type, the reported figures were: prostate cancer 50%, ovarian cancer 31.1%, pancreatic cancer 21.7%, breast cancer 12.9%, and other cancers 8.3%. A related measure looking only at participants with a detectable tumour at the start showed similar figures, ranging from 9.1% (other cancers) to 57.1% (prostate cancer) across groups. The reported data also shows figures for how long, on average, participants went without their disease getting worse — ranging from about 3.7 months (breast cancer) to about 7.2 months (prostate cancer). Average overall survival figures ranged from about 9.8 months (pancreatic cancer) to about 18.4 months (prostate cancer). The proportion of participants still alive at 12 months ranged from about 41% (pancreatic cancer) to about 64% (ovarian cancer). For participants whose tumour did respond, the reported duration of that response ranged from 134 days (pancreatic cancer) to 326.5 days (prostate cancer). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01533246 · results posted 13 March 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 17 people, all of whom received the study drug linsitinib. The trial was looking at how a prostate cancer marker in the blood called PSA (prostate-specific antigen) responded to treatment, as well as how tumours changed in size, how long it took for the disease to progress, and how long participants lived. Fifteen of the 17 participants completed the study, and two did not. The reported data shows that when it came to the main thing being measured — a meaningful drop in PSA levels (a fall of at least 50%, confirmed by a second test at least four weeks later) — 1 out of 17 participants met that threshold, while 16 did not. For tumour size changes (measured using a standard system called RECIST), the reported data shows 1 participant had tumours shrink (a "partial response"), 8 had disease that stayed roughly the same ("stable disease"), and 1 had disease that grew ("progressive disease"); results for the remaining participants in this category were not reported in the data provided. On average, the time before PSA levels started rising again was reported as 1.8 months, the median time before the disease progressed or a participant died was reported as 4.7 months, and the median overall survival figure reported was 3.7 months. For side effects, the reported data shows 1 participant experienced a serious (grade 3 or higher) side effect considered at least possibly related to the treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00253643 · results posted 18 February 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 89 men across four groups, each receiving a different combination of fish oil capsules and green tea catechin extract (a compound found in green tea) — either both active supplements, one of each (active and dummy/placebo), or both placebos. The trial was measuring two things in prostate tissue samples taken before and after the supplement period: the level of a protein called fatty acid synthase (FAS), which is involved in how cells make fats, and the rate at which cells were dividing, measured using a marker called Ki-67. Most participants completed the trial — 85 out of 89 finished. The reported data shows that for the FAS protein score (measured on a scale of 0 to 300), the starting scores across the four groups ranged from roughly 102 to 159. After the intervention, the scores shifted differently across groups: the group receiving both active supplements moved from 147 to 141, the group receiving green tea extract with placebo fish oil moved from 159 to 159, the group receiving fish oil with placebo green tea moved from 138 to 145, and the placebo-only group moved from 102 to 152. For cell division (Ki-67), the reported data shows post-intervention percentages of cells dividing of 18.5% in the both-active group, 8% in the green tea-only group, 10% in the fish oil-only group, and 12% in the placebo-only group. The pre-intervention Ki-67 figures were not separately reported in the submitted data. It is worth noting that the groups were quite small — ranging from 14 to 31 people — which is typical for an early-stage trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00928174 · results posted 19 November 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 27 participants, all placed in a single group with no comparison group. The study was measuring how well a type of medical scan — called a Fluorine-18 Fluorocholine PET/CT scan — lined up with blood test results for a substance called PSA (Prostate Specific Antigen), which is commonly checked in people with prostate cancer. Twenty-two participants completed the study, and five did not finish. The reported data shows that the trial looked at what percentage of participants in different PSA level ranges had at least one abnormal area show up on the PET/CT scan — an area where the scan detected something that could suggest prostate cancer had spread or come back. According to the results reported on ClinicalTrials.gov, in three of the four PSA ranges examined, 100% of participants in those ranges had an abnormal area detected on the scan. In the remaining PSA range, the reported figure was 0% — meaning no participants in that particular range had an abnormal area detected. The specific PSA ranges and how many people fell into each category were not detailed in the submitted data. It is worth noting that the reported data does not break down participant numbers within each PSA range, so it is not possible to know how many people sit behind each of those percentage figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00937833 · results posted 13 November 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT00937833) involved 150 men who had undergone prostate removal surgery (prostatectomy). They were divided into two groups: 73 men received a urethrovesical sling — a surgical device placed to support the bladder outlet — and 77 men were in a control group that did not receive the sling. The trial was measuring how many men in each group regained bladder control (continence) after their prostate removal surgery. The reported data shows that, of those who completed the study, 37 out of the 73 men in the sling group were recorded as continent, compared with 32 out of the 77 men in the control group. It is worth noting that not everyone who started the trial finished it — 15 men in the sling group and 17 men in the control group did not complete the study, and the reasons for this were not detailed in the data provided. No secondary outcome measure results were included in the submitted data, so those figures cannot be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00365105 · results posted 10 November 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 261 people in total — 129 in the group receiving zoledronic acid alone, and 132 in the group receiving zoledronic acid combined with radiopharmaceuticals (a type of radioactive medicine given to target areas of cancer in bone). The trial was primarily measuring how long it took for participants to experience what is called a "skeletal-related event" (SRE) — meaning a bone fracture caused by cancer, spinal cord compression, or the need for surgery or radiation to a bone. It also looked at a number of secondary measures including how many people had an SRE within one year, how long participants survived, and how their quality of life and pain levels changed over time. The reported data shows that the median time — meaning the point at which half the participants had experienced an SRE — was 29.9 months in the zoledronic acid alone group and 27.4 months in the combination group. For the secondary outcomes, within one year, 28 participants in the zoledronic acid group and 20 in the combination group were reported to have experienced an SRE. The reported median overall survival was 32.1 months in the zoledronic acid group and 26.9 months in the combination group. Quality of life scores (measured using standard questionnaires) showed small changes from baseline in both groups at one year; for example, on the FACT-G quality of life scale (which runs from 0 to 108, with higher being better), both groups showed a decline of around 1 to 2 points. Pain scores and other quality of life measures showed similarly small numerical differences between the two groups, as reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00079001 · results posted 30 October 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 645 men with prostate cancer — 323 received zoledronic acid alongside androgen deprivation therapy (a hormone-lowering treatment), and 322 received a placebo (an inactive dummy treatment) alongside the same hormone therapy. The trial's main focus was measuring how long it took before participants experienced a "skeletal-related event" — meaning things like a broken bone, radiation treatment to a bone, surgery on a bone, spinal cord compression, or death from prostate cancer. The reported data shows that, on average (using a statistical method called Kaplan-Meier, which estimates the midpoint at which half the group had experienced an event), the time to a first skeletal-related event was 31.9 months in the zoledronic acid group and 28.8 months in the placebo group. For overall survival — how long participants lived from the start of the trial — the reported midpoint figures were 37.9 months in the zoledronic acid group and 36.0 months in the placebo group. The trial also measured progression-free survival, meaning the time before the disease worsened or death occurred, whichever came first; the reported midpoint figures were 10.6 months in the zoledronic acid group and 9.2 months in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00587431 · results posted 21 August 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 102 men with prostate cancer across two groups. Sixty-three participants received Lupron (a hormone-lowering drug) combined with a higher dose of the chemotherapy drug docetaxel (75 mg/m²) along with testosterone for seven days, while 39 participants received Lupron with a slightly lower dose of docetaxel (70 mg/m²) and testosterone for three days. The trial was measuring whether this combination could bring prostate-specific antigen (PSA — a protein in the blood often monitored in prostate cancer) down to very low levels, and also looking at how testosterone affected the way the body processed docetaxel. The reported data shows the following PSA results for participants whose cancer was detectable through a rising PSA after prior treatment: in the higher-dose docetaxel group, 9 out of that subgroup reached the target low PSA level, while 13 out of the corresponding subgroup in the lower-dose group did so. For participants with cancer that had spread to other parts of the body (metastatic), the reported data shows 14 reached the PSA target in the higher-dose group and 12 in the lower-dose group. A small number of additional participants in each group did not reach the target level — the reported figures for those were 0, 0, 3, and 2 respectively across the four subgroups. For the secondary measurement looking at how quickly docetaxel was cleared from the body (measured in litres per hour), the reported data shows figures of 23.9 L/hr in the first treatment cycle and 23.6 L/hr in the second cycle across all participants combined. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00424385 · results posted 21 July 2014
According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two medicines — imatinib and sorafenib — given together to patients enrolled across two groups, called Cohort 0 and Cohort 1. The trial was primarily measuring how many patients experienced what are called "dose-limiting toxicities" (DLTs) — that is, side effects serious enough to limit how much of the medicine could be given. A total of 17 patients started the trial across both cohorts (12 in Cohort 0 and 5 in Cohort 1). The doses were gradually increased in a step-by-step process to find the highest dose that could be given without too many serious side effects, known as the Maximum Tolerated Dose (MTD). The reported data shows that in Cohort 0, 1 out of the evaluable patients experienced a dose-limiting toxicity, while in Cohort 1, 2 out of the evaluable patients experienced one. Because 2 out of 6 evaluable patients in a cohort experiencing a DLT was the pre-set signal that the maximum tolerated dose had been exceeded, this meant the MTD was considered to be the dose level used in the previous cohort. For the secondary outcomes, the reported data shows that 20% of evaluable participants across both cohorts combined experienced what was termed "overall clinical benefit" — which included patients whose disease completely disappeared, partially shrank, or remained stable. The reported median time until disease progression was 2 months, with a range of 1 to 5 months across the 10 patients evaluated for this measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01696981 · results posted 21 July 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01696981) involved over 154,000 people in total — roughly 77,455 in the control group (usual care, no special screening) and 77,445 in the colorectal screening group. The trial was measuring whether offering bowel cancer screening made a difference to the number of people who died from bowel cancer, as well as tracking overall deaths from any cause, new bowel cancer diagnoses, and complications arising from follow-up tests after a positive screening result. The reported data shows that, for the primary outcome, 341 people in the control group died from bowel cancer compared with 252 people in the screening group. For overall deaths from any cause, the numbers were 11,064 in the control group and 10,835 in the screening group. When expressed as a rate (the number of deaths for every 10,000 years of follow-up time across all participants), the reported data shows 127.0 deaths per 10,000 person-years in the control group and 124.3 in the screening group. Regarding new bowel cancer diagnoses, 1,287 were recorded in the control group and 1,012 in the screening group — rates of 15.2 and 11.9 per 10,000 person-years respectively. For complications during follow-up testing after a positive screening result, the reported data shows figures of 58 and 279 participants experiencing complications, though the way these two figures relate to each other was not clearly distinguished in the data as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00473746 · results posted 29 April 2014
According to the results reported on ClinicalTrials.gov, this trial had two phases. In Phase 1, a total of 33 people took part across four groups, each receiving a different daily dose of the study drug abiraterone acetate (250 mg, 500 mg, 750 mg, or 1,000 mg per day). The goal of Phase 1 was to find the highest dose that did not cause unacceptable side effects — a level known as the "maximum tolerated dose." Phase 2 then enrolled 33 participants, all receiving 1,000 mg per day, and the main thing being measured was how many participants had their PSA (prostate-specific antigen, a protein measured in the blood that is often tracked in prostate cancer) drop by 50% or more. The reported data shows that for the Phase 1 primary outcome — identifying the maximum tolerated dose — no numeric result was provided in the submitted data. For the Phase 2 primary outcome, out of the 33 participants who started that phase, 26 were assessed and 2 were reported in a separate sub-count, with the data listing a combined figure of 28 participants as having experienced a drop in PSA of 50% or more. Regarding the blood-level measurements taken during Phase 1, the reported data shows that the peak level of the drug detected in the bloodstream tended to be higher at higher doses, ranging from around 283 to 510 nmol/L (a unit measuring concentration in blood) at one time point across the four dose groups, and from around 421 to 2,194 nmol/L at another. The time it took to reach that peak level was generally between 1.5 and 4 hours across all dose groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00919035 · results posted 7 April 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 21 participants, all of whom completed the study. All participants received the drug Torisel (also known as temsirolimus). The trial was looking at how Torisel performed in men with a form of prostate cancer called castration-resistant prostate cancer (CRPC) who had not yet received chemotherapy. The main thing being measured was "overall clinical benefit" — meaning how many participants showed either their cancer disappearing completely, shrinking noticeably, or staying stable (not getting worse). The reported data shows that 67% of participants fell into the "overall clinical benefit" category — meaning their cancer either disappeared, shrank by more than 30%, or stayed stable during the study. For the secondary measures, the reported data shows that the average time until the disease started progressing (getting worse) was 2 months. The trial also looked at whether a blood marker called PSA — a protein that can be measured to monitor prostate cancer — took longer to double while participants were on the treatment compared to before. PSA doubling time is simply how long it takes for that number to double, with a longer doubling time generally considered a slower-moving cancer. The reported data shows that 0% of participants showed a change in their PSA doubling time before and after treatment. It is worth noting that this was a small trial of only 21 people, and the results represent what was observed in that specific group under those specific conditions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00524589 · results posted 10 March 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 18 people who received a combination of two medicines — dexamethasone and calcitriol — for what appears to have been a cancer-related condition. The trial was primarily measuring whether participants' tumours showed a measurable reduction in size, using a standard set of imaging criteria known as RECIST (a recognised system for measuring how tumours respond on scans). A secondary measure tracked how many participants had a particular level of calcium in their blood on at least one occasion during the trial. The reported data shows that none of the 18 participants (0%) showed a measurable reduction in tumour size — meaning no complete or partial responses were recorded under the RECIST criteria. For the secondary measure, the reported data shows that 6 out of 18 participants had corrected blood calcium levels falling between 11 mg/dL and 12 mg/dL (a higher-than-normal range) on one or more occasions during the study. It is also worth noting that, according to the results reported on ClinicalTrials.gov, none of the 18 participants were recorded as having completed the trial, though the reason for this was not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00459186 · results posted 3 March 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 19 participants, all of whom were in a single group that first received a drug called RAD001 on its own, then moved on to receive RAD001 combined with another drug called docetaxel. The trial was measuring two main things: how many people could take the combination of RAD001 and docetaxel without experiencing serious side effects (called "dose limiting toxicities" — meaning side effects severe enough to limit how much of the drug could be given), and how participants' tumours responded to RAD001 alone as measured by a type of body scan called a PET scan. The reported data shows that, out of the 15 participants who reached the combination treatment phase, 14 did not experience a dose limiting toxicity during the first 21 days of that treatment. For the PET scan results, 18 participants were scanned before and after receiving RAD001 alone, and 15 completed that assessment. Of those assessed, the reported data shows approximately 22% showed a partial metabolic response (meaning the scan suggested a notable reduction in activity), 67% had stable metabolic disease (meaning little change was detected), and 11% showed progressive metabolic disease (meaning the scan suggested increased activity). It is worth noting that one participant did not complete the first phase of the trial, and three did not complete the PET imaging assessment phase — the reasons for this were not detailed in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00487721 · results posted 28 February 2014
According to the results reported on ClinicalTrials.gov, this trial involved 12 people in total — 6 in the Silibin-Phytosome group and 6 in the control group. All 12 participants completed the study with no drop-outs. The trial was measuring whether a substance called silibinin (a compound derived from milk thistle, taken as a supplement called Silybin-Phytosome) could be detected in prostate tissue after men took it according to the study protocol. Detecting the substance in tissue was the main thing the researchers were looking to confirm. The reported data shows that out of the 6 participants who received Silybin-Phytosome, measurable levels of silibinin were detected in the prostate tissue of 3 of them. The results for the control group were not reported in the data submitted to ClinicalTrials.gov. No other outcome measures were included in the submitted results data, so no further numbers are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00950911 · results posted 11 February 2014
According to the results reported on ClinicalTrials.gov, this trial involved 35 people in total — 17 in one group and 18 in another. The study compared two different treatment approaches: one group started on a medicine called zoledronic acid and then switched to denosumab, while the other group received denosumab throughout. Both medicines are given by injection every four weeks. The trial tracked how many participants survived over the course of the study. The reported data shows that out of the 17 people in the first group (zoledronic acid followed by denosumab), 13 were reported as having survived. In the second group (denosumab throughout), 12 out of 18 participants were reported as having survived. It is also worth noting that a large number of participants did not complete the study — 12 from the first group and 15 from the second group left before the trial finished, for reasons the data does not specify. No other outcome measures were included in the results submitted to ClinicalTrials.gov. It is important to note that this was a relatively small trial, and the reported results reflect only the numbers submitted by the study sponsor. No secondary outcome data was reported in the submitted results, so a fuller picture of what was measured is not available from this source. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00170157 · results posted 31 January 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 112 men with prostate cancer across two groups. One group of 54 participants received androgen ablative (AA) therapy — a treatment that lowers male hormone levels — combined with a drug called MDX-010 from the start. The other group of 58 participants received AA therapy alone first, then crossed over to receive both treatments together after a short washout (rest) period. The trial was measuring how many men remained free of disease progression — meaning no significant rise in their PSA (prostate-specific antigen, a protein measured in the blood that can indicate prostate cancer activity) — at 18 months, as well as how many men had PSA levels drop to undetectable levels at the three-month mark. The reported data shows that for the primary outcome — the number of participants who were progression-free at 18 months across the entire study population — the recorded figure was zero. It is important to note that this may reflect how the data was captured or reported rather than a straightforward clinical finding, but no further explanation is provided in the submitted data. For the secondary outcome, the reported data shows that 55% of participants in the group that received AA therapy combined with MDX-010 from the beginning had undetectable PSA levels at three months, compared with 39% of participants in the group that received AA therapy alone first before crossing over. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00887458 · results posted 27 January 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 46 men with a type of advanced prostate cancer that had stopped responding to hormone therapy (known as metastatic castration-resistant prostate cancer). Participants were split into two groups: 17 received a lower daily dose of a medicine called itraconazole (200 mg), and 29 received a higher daily dose (600 mg). The trial was measuring how many men did not see their PSA — a protein in the blood often used to track prostate cancer — rise significantly after 24 weeks of treatment. All 17 men in the low-dose group finished the study, while 25 of the 29 men in the high-dose group completed it. The reported data shows that after 24 weeks, 11.8% of men in the low-dose group had not experienced a meaningful rise in their PSA level, compared with 48% of men in the high-dose group. For context, a "meaningful rise" was defined in the trial as PSA increasing by at least 25% above the starting (or lowest recorded) level, plus an absolute increase of at least 2 ng/mL, confirmed by a second blood test at least four weeks later. As a secondary measure — looking at a different marker, specifically the proportion of men whose PSA dropped by 50% or more from their starting level — the reported data shows 0% of the low-dose group and 14.3% of the high-dose group met this threshold. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00176631 · results posted 7 January 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 10 participants, all of whom completed the study — none dropped out. All participants received a combination of licorice root extract and docetaxel (a chemotherapy medicine). The trial was looking at two things: firstly, whether a protein marker in the blood called PSA — which can be measured to track certain cancers — dropped significantly during treatment; and secondly, whether levels of certain biological markers in the blood (BCL-2 and oestrogen receptor levels) changed differently between participants whose PSA responded and those whose PSA did not respond. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for either the primary outcome (the PSA response rate) or the secondary outcome (the changes in BCL-2 and oestrogen receptor levels). In other words, while the trial was completed and all 10 participants finished, the actual measurement figures for both outcomes were not reported in the structured data available on ClinicalTrials.gov. Because no results numbers were provided in the submission, it is not possible to describe what the measurements showed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00514917 · results posted 4 November 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 207 people in one group and 206 in another — a total of 413 participants with prostate cancer. One group received a combination of three treatments (docetaxel, leuprolide, and bicalutamide), while the other received two treatments (leuprolide and bicalutamide). The trial was primarily measuring how long participants went without their disease getting worse — called "progression-free survival" — based on rising levels of a prostate cancer marker in the blood (PSA), scans showing the cancer spreading, or death related to prostate cancer. The reported data shows that, on average, participants in the three-drug group went 25.4 months before their disease progressed, compared with 23.3 months in the two-drug group. When looking at who was still free from disease progression at the 36-month mark, the reported figures show 15.5% of the three-drug group and 8.6% of the two-drug group. For secondary outcomes, the reported data shows that during the study period, 4 participants in the three-drug group and 11 in the two-drug group died from any cause; of those, 2 and 3 respectively were recorded as dying specifically from prostate cancer. The researchers noted there were not enough deaths overall to carry out the planned survival analysis. The trial also measured participants' quality of life using a standard questionnaire (scored out of 156, where higher means better). The reported data shows both groups had similar scores at the end of treatment — around 121 for the three-drug group and 120 for the two-drug group — with both groups showing a small decline from their starting scores. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00828308 · results posted 1 November 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 16 participants, all of whom received a treatment called ixabepilone. All 16 participants completed the study — none dropped out. The trial was measuring changes in a substance in the blood called PSA (prostate-specific antigen), which is a protein produced by the prostate gland. Specifically, the researchers were tracking how many participants showed a decrease in their PSA level after 12 weeks on the treatment. The reported data shows that out of the 16 participants, 14 had a decrease in their PSA level after 12 weeks of receiving ixabepilone. No secondary outcome measures were included in the data submitted to ClinicalTrials.gov, so no additional findings can be described here. It is also worth noting that with only 16 people in a single group, this was a very small study with no comparison group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00519285 · results posted 10 October 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 612 participants in each group — one group received a placebo and the other received a drug called aflibercept — giving a total of 1,224 people. Both groups were also receiving standard treatment (docetaxel chemotherapy with prednisone) for prostate cancer that had spread to the bones. The trial was primarily measuring how long participants lived overall, and also tracked a number of other things including changes in a prostate cancer marker in the blood (called PSA), how long before the cancer showed signs of getting worse, how long before bone-related complications occurred, and how tumours responded to treatment. The reported data shows that the median overall survival (that is, the midpoint of survival times across the group) was 21.22 months for the placebo group and 22.14 months for the aflibercept group. For the secondary measures, the reported data shows a PSA response (a drop of at least 50% in PSA levels) was recorded in 63.5% of placebo participants and 68.6% of aflibercept participants. The median time before bone-related complications or death was reported as 14.98 months (placebo) and 15.31 months (aflibercept). The median time before any sign of disease progression or death was 6.24 months (placebo) and 6.90 months (aflibercept). Among participants whose tumours could be directly measured, a meaningful tumour shrinkage was recorded in 28.1% of the placebo group and 38.7% of the aflibercept group. Finally, the median time before PSA levels rose significantly or death occurred was 8.11 months (placebo) and 8.25 months (aflibercept). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00988208 · results posted 5 September 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,059 men with advanced prostate cancer — 526 in one group and 533 in the other. One group received a combination of docetaxel, prednisone, and a placebo, while the other received docetaxel, prednisone, and an additional medicine called lenalidomide. The trial's main goal was to measure how long participants lived overall, and it also tracked how long the disease took to get worse, how many participants saw their tumours shrink or disappear, and what unwanted health events occurred during treatment. The reported data shows that for the main measure — overall survival, meaning time from entering the trial until death from any cause — a median figure (the midpoint result for the group) was only reported for the lenalidomide group at 77 weeks; the equivalent figure for the placebo group was listed as "not available" in the submitted data. For disease progression (the time until the cancer got worse or a participant died), both groups recorded very similar figures: 46 weeks for the placebo group and 45 weeks for the lenalidomide group. The proportion of participants whose tumours shrank significantly was also similar: 24.3% in the placebo group and 22.1% in the lenalidomide group. Regarding unwanted health events during the study, the reported data shows that more participants in the lenalidomide group experienced serious or severe adverse events — for example, 167 participants in the lenalidomide group experienced life-threatening events compared with 62 in the placebo group. Around 70% of participants in both groups went on to receive further treatments after the study ended. The reported data also shows that a small percentage of participants in both groups developed a new, separate cancer during the trial: approximately 1.3% in the placebo group and 1.7% in the lenalidomide group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01215513 · results posted 22 May 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 157 participants, all of whom received a medicine called degarelix. The trial was an open-label, single-arm study — meaning everyone received the same treatment and there was no comparison group. The main things the trial was measuring were changes in laboratory test results, heart tracing (ECG) readings, vital signs (such as blood pressure and pulse), and body weight. A secondary measure tracked levels of a protein called PSA (prostate-specific antigen) — a substance in the blood that is commonly monitored in people with prostate conditions — over time. Of the 157 people who started, 112 completed the study. The reported data shows that, among the safety measurements, small numbers of participants had readings that fell outside the normal range at some point during the trial. For laboratory blood and urine tests, the number of participants with a notably abnormal result for any single variable ranged from 1 to 83 out of those assessed. For vital signs and body weight, between 0 and 20 participants showed a notably abnormal reading depending on which measurement is looked at. For heart tracing variables, between 1 and 69 participants had a notably abnormal reading for any individual ECG measure. The reported data does not break down what each specific numbered category refers to for most of these figures, as the full variable labels were not included in the submitted data. For the secondary outcome, the reported data shows that the median PSA level at the start of the study (day 0) was 19.2 ng/mL across 155 participants. By day 196 (roughly six and a half months), the median had dropped to 0.67 ng/mL in 148 participants; by day 280 it was 0.52 ng/mL in 115 participants; and by day 364 (approximately one year) it was 0.46 ng/mL in 109 participants. These are the PSA levels as recorded and reported — no other outcome data beyond these figures was included in the submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00638690 · results posted 16 May 2013
According to the results reported on ClinicalTrials.gov, this trial involved 1,195 people with prostate cancer — 797 were given abiraterone acetate and 398 received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring how long participants lived overall, and also tracked several other things: how long before a protein in the blood called PSA (prostate-specific antigen) showed signs of the cancer progressing, how many participants had a large drop in their PSA levels, and how long before scans showed the cancer had visibly progressed. The reported data shows that, for overall survival, the median time from entering the trial to death from any cause was 450 days in the abiraterone acetate group and 332 days in the placebo group. (Median means the middle value — half of participants lasted longer than this, half did not.) For the PSA progression measure, the reported median time before PSA levels met the criteria for progression was 309 days in the abiraterone acetate group and 200 days in the placebo group. The reported data shows that 232 out of 797 participants in the abiraterone acetate group had their PSA levels drop by 50% or more from their starting level, compared with 22 out of 398 in the placebo group. For the scan-based progression measure, the reported median time before visible progression was 171 days in the abiraterone acetate group and 110 days in the placebo group. It is also worth noting that the reported data shows a relatively small number of participants were recorded as completing the study — 116 in the abiraterone acetate group and 56 in the placebo group — though the data as reported does not explain in detail why the remaining participants did not complete it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00110214 · results posted 17 April 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,050 men with prostate cancer — 526 in one group who received the chemotherapy drug docetaxel plus a placebo (inactive substance), and 524 in a second group who received docetaxel plus a drug called bevacizumab. The trial was primarily measuring how long participants lived overall, and also looked at a number of secondary measures: whether a blood marker for prostate cancer called PSA dropped by at least half, how long participants went without their cancer getting worse, and how many experienced serious side effects (graded as severe or higher). The reported data shows that for overall survival — measured from when participants joined the trial until death from any cause — the median time (the point at which half of participants had died) was 21.5 months in the docetaxel-plus-placebo group and 22.6 months in the docetaxel-plus-bevacizumab group. For the secondary measure of how long participants went before their cancer worsened or they died (called progression-free survival), the reported median figures were 7.5 months and 9.9 months respectively. The reported data also shows that 57.9% of participants in the placebo group and 69.5% in the bevacizumab group had their PSA blood marker fall by at least 50%. Regarding serious side effects considered at least possibly related to treatment, the reported data shows that 56.2% of the placebo group and 75.4% of the bevacizumab group experienced side effects graded as severe, life-threatening, or fatal. It is worth noting that only a small number of participants — 17 in the placebo group and 21 in the bevacizumab group — were recorded as having formally "completed" the trial, with the large majority not completing it, which is common in cancer trials where participants may leave for various reasons including death or disease progression. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00313781 · results posted 11 April 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 204 people with prostate cancer — 102 in a group receiving a combination of an experimental drug called CP-751,871 together with the chemotherapy drugs docetaxel and prednisone, and 102 in a group receiving docetaxel and prednisone alone. A third group of 37 participants crossed over from the docetaxel-and-prednisone-only group to also receive CP-751,871 at a later stage. The trial's main goal was to measure how many participants showed a meaningful drop in a blood marker called PSA (prostate-specific antigen), which is often tracked in prostate cancer. Secondary goals included looking at how long participants went without their disease getting worse (called progression-free survival). The reported data shows that for the primary measure — the proportion of participants with a notable PSA reduction — 51.7% of those in the combination group (CP-751,871 plus docetaxel and prednisone) met the response criteria, compared with 60.2% in the docetaxel-and-prednisone-only group, and 28.1% among those who crossed over to receive CP-751,871 later. For progression-free survival, the reported median time without disease worsening was 4.9 months in the combination group, 7.7 months in the docetaxel-and-prednisone-only group, and 4.0 months in the crossover group. The trial also measured certain antibody levels in the blood (HAHA) and tracked circulating tumour cells (cancer cells detected in the blood), though the data on circulating tumour cells was presented across multiple time points and some pharmacokinetic (drug movement in the body) data was not reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00451958 · results posted 21 March 2013
According to the results reported on ClinicalTrials.gov, this trial (called CS21A) was an extension of an earlier study (CS21). It enrolled 386 men with prostate cancer across four treatment groups, all receiving injections of either degarelix (at two different maintenance doses) or having switched from leuprolide to degarelix. The trial was measuring changes in vital signs and blood test results, as well as tracking a protein linked to prostate cancer called PSA (prostate-specific antigen) and a hormone called testosterone over time. The reported data shows that when looking at markedly abnormal readings in vital signs — such as blood pressure, pulse, and body weight — only small numbers of participants were affected across all groups, ranging from 0 to 6 people per measurement per group. Similarly, for laboratory blood test results, the number of participants with markedly abnormal values was generally small, ranging from 0 to 11 people per measurement per group. For PSA progression (defined as two back-to-back rises of 50% or more above each person's lowest recorded level), the reported data shows that at an early time point, between 98.6% and 100% of participants across the groups had not experienced progression. At a later point in the study, this figure ranged from roughly 50.7% to 73.8% across the groups. For testosterone levels (a hormone the treatment aims to keep low), between 97.6% and 100% of participants had testosterone at or below the target level at an early time point, dropping to between 82% and 88.4% at a later time point — with the reported data noting that across all groups, approximately 3% of participants per year had at least one reading above the target level. For men who switched from leuprolide to degarelix, both testosterone and PSA blood levels remained low and relatively stable over the 56 days following the switch, with testosterone readings consistently reported around 0.066–0.085 ng/mL and PSA readings around 0.3–0.5 ng/mL across both switch groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00676650 · results posted 8 March 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 873 people in total — 584 in the group receiving sunitinib (a targeted medicine) combined with prednisone (a steroid), and 289 in the group receiving a placebo (a dummy treatment) combined with prednisone. The trial was designed to measure how long participants lived overall, how long they lived before their cancer got worse, whether tumours shrank, how long any shrinkage lasted, and how participants felt in terms of pain and quality of life. The reported data shows that, for overall survival — meaning the time from joining the trial until death — participants in the sunitinib-and-prednisone group had a reported median (the middle value in the range of results) of 13.1 months, compared with 11.8 months in the placebo-and-prednisone group. For progression-free survival — meaning the time before the cancer got worse or a participant died — the reported figures were 24.1 weeks for the sunitinib-and-prednisone group and 17.9 weeks for the placebo-and-prednisone group. When it came to tumour response (whether tumours shrank by a meaningful amount), 6.1% of participants in the sunitinib-and-prednisone group showed a response, compared with 1.8% in the placebo-and-prednisone group. The reported data shows that results for duration of tumour response, changes in pain scores, and quality-of-life scores were not reported in the ClinicalTrials.gov submission, so no figures for those outcomes are available here. It is also worth noting that zero participants were recorded as having "completed" the study in the formal sense, meaning all participants either withdrew, progressed, or died before a formal study completion was recorded — which is not unusual in trials of this kind. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01071915 · results posted 12 February 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 157 men who received a drug called degarelix (given as injections at a starting dose of 240 mg, then 80 mg maintenance doses). The trial was measuring whether the drug could lower testosterone to what researchers call "castrate level" — a very low level of 0.5 ng/mL or below — and keep it there over roughly six months. A total of 148 men completed the trial, with 9 not completing it. The reported data shows that for the main outcome, there was a 96.7% cumulative probability of testosterone staying at or below that low threshold from Day 28 through to Day 196 (about six and a half months). For the secondary outcomes, 97.4% of participants had testosterone at or below that threshold as early as Day 3. The reported data also shows an average reduction in PSA (prostate-specific antigen, a protein measured in the blood that is often monitored in prostate conditions) of 79.7% from the starting point to Day 28. The probability of avoiding a significant PSA rise (defined as two back-to-back increases of at least 50% and above 5 ng/mL compared to the lowest recorded level) from Day 28 to Day 196 was reported as 97.3%. Regarding laboratory test results, the data shows that varying numbers of participants — ranging from 1 to 73 across different variables — had results flagged as markedly abnormal at some point during the study, though the full breakdown of which specific tests these figures relate to was not clearly separated in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00030901 · results posted 6 February 2013
According to the results reported on ClinicalTrials.gov, this trial (NCT00030901) enrolled 619 people in an initial registration phase, of whom 452 moved forward. From that group, 452 were considered for a randomised phase — where participants are split by chance into groups — with 227 assigned to receive selenium (a mineral supplement) and 225 assigned to receive a placebo (a dummy treatment with no active ingredient). The trial was measuring whether taking selenium would reduce the chances of being diagnosed with prostate cancer, confirmed by biopsy (a tissue sample test), within three years of joining the treatment phase. The reported data shows that, at the end of the three-year period, 48 out of 227 participants in the selenium group and 49 out of 225 participants in the placebo group had prostate cancer detected by biopsy. The reported data also shows results for a secondary measure looking at serious unwanted effects (graded as severe, life-threatening, or fatal) that were considered related to the study treatment. According to the results reported on ClinicalTrials.gov, no participants in the selenium group experienced severe or life-threatening events related to the study drug, while one participant in the placebo group had a severe event and one had a life-threatening event; one participant in the selenium group had an event recorded in another category, and no further breakdown beyond these figures was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00006392 · results posted 6 November 2012
According to the results reported on ClinicalTrials.gov, this trial (known as the SELECT trial) enrolled 35,533 men across four groups: one group took Vitamin E, one took Selenium, one took both supplements in combination, and one took a placebo (a dummy pill with no active ingredient). The trial's main goal was to count how many men in each group were diagnosed with prostate cancer over a follow-up period of seven to twelve years, with check-ins every six months. The reported data shows that for the primary measure — prostate cancer diagnoses — 473 men in the Vitamin E group, 432 in the Selenium group, 437 in the Combination group, and 416 in the Placebo group received a prostate cancer diagnosis. For the secondary measures, lung cancer was reported in 67, 75, 78, and 67 participants across the four groups respectively, and colorectal cancer in 66, 63, 77, and 60 participants. When looking at any cancer diagnosis combined, the numbers were 856, 837, 846, and 824 across the four groups. Serious cardiovascular events (such as heart-related problems, based on self-report and not independently confirmed) were recorded in 1,034, 1,080, 1,041, and 1,050 participants across the groups. The reported data for the survival-related secondary outcomes includes some figures, but the way they were submitted makes a complete plain-English breakdown of all sub-measures difficult to provide without risk of misrepresentation, so readers should refer directly to ClinicalTrials.gov for the full detail. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00974311 · results posted 30 October 2012
According to the results reported on ClinicalTrials.gov, this trial (NCT00974311) enrolled 1,199 participants in total — 800 received enzalutamide and 399 received a placebo (a dummy treatment with no active ingredient). The trial was studying men with prostate cancer, and its main goal was to measure how long participants lived overall. It also tracked a number of secondary goals, including how long it took for cancer to show visible signs of spreading further on scans, how long before certain bone-related complications occurred, changes in a quality-of-life questionnaire score, how long before a specific blood marker (PSA) rose, and whether participants reported reduced pain. The reported data shows that for the main outcome — overall survival — participants in the enzalutamide group had a reported median survival of 18.4 months from the start of the trial, compared with 13.6 months in the placebo group. (Median means half the participants in each group lived longer than that figure, and half did not reach it.) For the secondary outcomes, the reported data shows: the median time before cancer showed radiographic (scan-based) progression or death was 8.3 months for the enzalutamide group versus 2.9 months for the placebo group; the median time to the first bone-related complication was 16.7 months versus 13.3 months; the median time before the PSA blood marker progressed was 8.3 months versus 3.0 months. For the quality-of-life questionnaire (FACT-P), 43.2% of participants in the enzalutamide group were reported as "responders" (meaning a meaningful improvement in their score on two consecutive checks) compared with 18.3% in the placebo group. For pain reduction, 44.9% of enzalutamide participants met the threshold for reported pain palliation at Week 13, compared with 6.7% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00090363 · results posted 3 September 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 312 men across three groups: 107 received a placebo (a dummy treatment with no active ingredient), 107 received a 10 mg dose of a drug called ZD4054, and 98 received a 15 mg dose of ZD4054. The trial was measuring how long it took for participants' cancer to get worse (called "time to progression"), how long participants lived, changes in a prostate cancer marker in the blood called PSA, whether tumours shrank, and changes in the number of bone metastases (spots where cancer had spread to bone). Very few participants completed the full study period — only 1, 0, and 2 in each group respectively — with the large majority not completing, though the data does not explain the reasons in detail. The reported data shows that the median time until disease progression (the point by which half the participants in each group had experienced worsening) was 111 days for the placebo group, 138 days for the 10 mg ZD4054 group, and 113 days for the 15 mg ZD4054 group. For time until death, the reported median figures were 596 days for the placebo group, 706 days for the 10 mg group, and 717 days for the 15 mg group. Regarding PSA levels at 12 weeks, the reported percentage change from the starting point was an increase of 110.4% in the placebo group, an increase of 131.6% in the 10 mg group, and an increase of 69.3% in the 15 mg group. No participants in any group showed a measurable shrinkage of tumours (0% objective response rate across all three groups). The reported percentage change in the number of bone metastases was an increase of 187.1% in the placebo group, 113.4% in the 10 mg group, and 189% in the 15 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00327340 · results posted 29 August 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 69 people with prostate cancer who were receiving second-line chemotherapy — meaning chemotherapy given after an earlier treatment had stopped working. Twenty-three participants were placed in a group receiving a drug called custirsen (also known as OGX-011) combined with mitoxantrone and prednisone, while 46 participants received custirsen combined with docetaxel and prednisone. The trial was primarily looking at the safety and tolerability of custirsen alongside these chemotherapy combinations, and also tracked a number of secondary measures including changes in a prostate cancer marker in the blood (called PSA), pain progression over time, and levels of a protein called clusterin in the blood. The reported data shows that, for the primary measure of safety and tolerability, 100% of participants in both groups experienced at least one adverse event (an unwanted or unexpected medical occurrence) of any level of severity. When looking at more serious events, 83% of the mitoxantrone/prednisone group and 98% of the docetaxel/prednisone group experienced what were classified as Grade 3 or higher adverse events — meaning severe, life-threatening, or worse. For the secondary measures, the reported data shows that 17% of participants in the mitoxantrone/prednisone group and 31% in the docetaxel/prednisone group had a PSA response (defined as a drop of at least 50% in PSA levels). The reported time until pain got worse was 5.2 months in the mitoxantrone/prednisone group and 7.2 months in the docetaxel/prednisone group. For the clusterin and PSA relationship measure, the data was reported as percentages of participants with certain responses, though the full context of those figures was not described in detail in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00751790 · results posted 13 June 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 120 people, all of whom received a treatment called triptorelin. The trial was a single-group study, meaning everyone received the same treatment — there was no comparison group. The main thing the trial was measuring was whether triptorelin could lower testosterone levels in the blood to a specific low threshold (called "castrate levels") within the first 28 days, and then keep them at that low level for up to 12 months. Testosterone levels in the blood were measured regularly throughout the study. Of the 120 people who started, 115 completed the trial and 5 did not finish. The reported data shows that 97.5% of the enrolled patients reached and maintained those low testosterone levels over the course of the study. In plain terms, that means roughly 117 out of 120 participants had their testosterone levels fall to the target threshold by day 28 and stay there through to the end of the 12-month period. Five people did not complete the trial, though the reasons were not detailed in the data provided here. The trial also listed several secondary measurements — including changes in a hormone called LH (which signals the body to produce testosterone), changes in a prostate-related protein called PSA, and detailed measurements of how the drug moved through the body in a smaller group of 15 participants. However, the reported data shows that no numerical results for these secondary outcomes were submitted to ClinicalTrials.gov, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00626548 · results posted 1 June 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 705 people in the ZD4054 (the treatment being tested) group and 716 people in the placebo (dummy treatment) group, for a total of 1,421 participants. The trial was studying men with prostate cancer and was primarily looking at two things: how long participants lived overall (called "overall survival"), and how long it took before their cancer showed signs of growing or spreading (called "progression-free survival"). It is worth noting that zero participants were recorded as having formally "completed" the trial, meaning all participants either withdrew, were lost to follow-up, or the trial ended before formal completion — the results below reflect an early review point (called a "data cut-off"). The reported data shows that at the early data cut-off point, 40 participants in the ZD4054 group and 39 participants in the placebo group had died — very similar numbers across both groups. For cancer progression (signs of the cancer growing or spreading), 131 participants in the ZD4054 group and 162 participants in the placebo group had experienced a progression event at that same early review point. For the three secondary outcomes — quality of life, time until a prostate-specific antigen (PSA, a protein used as a marker for prostate cancer) level rose, and time until symptoms worsened — the reported data shows no numbers were submitted to ClinicalTrials.gov for these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00554229 · results posted 31 May 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 299 people in the ZD4054 group and 295 people in the placebo (dummy treatment) group — a total of 594 participants. The trial was studying men with a form of advanced prostate cancer that had spread to the bones, and it was primarily measuring how long participants lived overall. It also tracked a number of secondary measurements, including how long before the cancer visibly grew, how long before stronger pain medicines (opiates) were needed, how long before bone-related complications occurred, how long before new bone lesions appeared, and how long before quality of life declined. The reported data shows that, for the main measurement — overall survival — the median time from joining the trial until death was 24.5 months in the ZD4054 group and 22.5 months in the placebo group. (Median means half the participants in each group had this outcome before that time, and half after.) For the secondary measurements, the reported data shows: the median time before the cancer showed signs of growing was 6.2 months (ZD4054) versus 6.5 months (placebo); the median time before opiate pain medicines were used was 16.7 months (ZD4054) versus 14.8 months (placebo); the median time before a bone-related complication occurred was 18.4 months (ZD4054) versus 17.1 months (placebo); the median time before four or more new bone lesions appeared was 15.1 months (ZD4054) versus 11.9 months (placebo); and the median time before a meaningful decline in quality of life was recorded was 5.5 months in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT00617669 · results posted 31 May 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 524 people in the ZD4054 plus docetaxel (chemotherapy) group and 528 people in the placebo plus docetaxel group — just over 1,050 participants in total. The trial was looking at men with prostate cancer, and it was measuring things like how long people lived overall, how long it took for the cancer to get worse, and whether they experienced bone-related complications or changes in pain levels. The reported data shows that for overall survival — the main thing the trial was measuring — the median time from the start of the trial until death was 20.0 months in the ZD4054 group and 19.2 months in the placebo group. (Median means half of the participants in each group lived longer than this, and half did not.) For the secondary measures: the median time until the cancer progressed was 7.0 months versus 7.9 months; the median time until a bone-related event (such as a fracture or spinal complication) was 17.4 months versus 17.3 months; the median time until a PSA blood marker rose significantly was 11.9 months versus 12.1 months; and the median time until pain worsened was 9.3 months versus 10.0 months. For pain response — the number of people whose pain scores or painkiller use decreased — 255 participants in the ZD4054 group and 276 in the placebo group recorded a response. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00884273 · results posted 11 April 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 84 people in the degarelix group and 98 people in the goserelin-plus-bicalutamide group — 182 participants in total. The trial was designed for men with prostate conditions, and it measured changes in prostate size (using an ultrasound technique called TRUS), urinary symptoms, quality of life related to urinary symptoms, and levels of two substances in the blood — testosterone and PSA (a protein produced by the prostate). The reported data shows that, for the main measurement at 12 weeks, prostate size decreased by an average of 37.2 millilitres in the degarelix group and 39.0 millilitres in the goserelin-plus-bicalutamide group. Earlier time points told a similar story: at 4 weeks the reductions were 19.2 mL and 21.2 mL respectively, and at 8 weeks they were 33.1 mL and 33.2 mL. Urinary symptom scores (measured on a 0–35 scale where higher numbers mean worse symptoms) decreased over the 12 weeks in both groups — by 4.39 points in the degarelix group and 2.74 points in the goserelin-plus-bicalutamide group by week 12. Quality-of-life scores related to urinary symptoms (on a 0–6 scale) also decreased in both groups, with very similar reductions by week 12 (around 1 point in each group). Blood testosterone levels fell by roughly 4 nanograms per millilitre in both groups across all time points. PSA levels in the blood decreased in both groups, with the reported reductions generally appearing larger in the degarelix group (e.g. –25.15 ng/mL at week 12) than in the goserelin-plus-bicalutamide group (–13.1 ng/mL at week 12). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00861471 · results posted 29 June 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants, all of whom received a combination of two medicines — docetaxel and Gleevec (imatinib). The trial was measuring how participants with prostate cancer responded to this combination treatment, with the main focus on changes in a blood marker called PSA (prostate-specific antigen), which is commonly monitored in prostate cancer care. Of the 12 people who started the trial, only 3 completed it, and 9 did not complete it (the reasons were not detailed in the reported data). The reported data shows that 50% of participants had their PSA level drop by at least half from their starting level without signs of the cancer growing or spreading — this was the main outcome the trial was designed to measure. For secondary outcomes, the reported data shows that 16% of participants had an even larger PSA drop of 80% or more from their starting level. Among those with tumours that could be directly measured by scans, 20% showed a reduction in tumour size. On average (as a median, meaning the midpoint for the group), the time before PSA levels started rising again was reported as 188 days. The reported median overall survival — the point at which half of participants were still alive — was 24.9 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00498797 · results posted 24 May 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 86 men with prostate cancer, split into two equal groups of 43 — one group received a drug called vandetanib, and the other received a placebo (a dummy treatment with no active ingredient). The trial was primarily looking at whether the men's PSA levels — a protein in the blood that is often monitored in prostate cancer — dropped by at least half from their starting level, with that drop confirmed by a second test two to four weeks later. Far fewer participants in each group completed the full study than started it: only 5 of the 43 in the vandetanib group and 14 of the 43 in the placebo group finished. The reported data shows that, for the primary measure (PSA dropping by at least 50%), 17 out of 43 participants in the vandetanib group and 29 out of 43 in the placebo group met this target. For the secondary measure — tracking how many participants experienced their disease getting objectively worse, or died — the reported data shows 28 out of 43 in the vandetanib group and 26 out of 43 in the placebo group had one of these events. No further breakdown of these figures was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00385580 · results posted 1 March 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 95 people with prostate cancer across two groups: 48 participants received dasatinib at a dose of 100 mg once daily, and 47 received dasatinib at 100 mg or 70 mg twice daily. All 95 participants who started the trial were recorded as having completed it. The trial was measuring whether participants showed a "response" — defined as a meaningful reduction in a prostate cancer blood marker called PSA (prostate-specific antigen), an improvement on a bone scan, a reduction in tumour size, or stable disease where tumours neither grew nor shrank significantly. The reported data shows that in the once-daily group, 12 out of 48 participants (25%) met the criteria for a response. In the twice-daily group, 13 out of 47 participants (27.7%) met the same criteria. When looking specifically at a drop in PSA levels of at least 50% from the starting level — one of the secondary things being measured — only 1 participant in each group (about 2.3% in both groups) reached that mark. For those individuals, the reported duration of that PSA reduction was approximately 0.82 months in the once-daily group and 11.17 months in the twice-daily group, though because only one person in each group achieved this, those figures represent single cases rather than averages across many people. The reported data also shows that 25 participants in the once-daily group and 16 in the twice-daily group had a decrease in how quickly their PSA levels were rising over time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00417079 · results posted 23 December 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 755 men with prostate cancer — 377 were assigned to receive mitoxantrone plus prednisone, and 378 received cabazitaxel plus prednisone. The trial was primarily measuring how long participants lived overall, and also tracked a number of secondary measures including how long it took for the disease to progress, how tumours responded to treatment, and how a blood marker for prostate cancer called PSA (prostate-specific antigen) changed over time. The reported data shows that for overall survival — the main thing being measured — the mitoxantrone plus prednisone group had a reported median survival of 12.7 months, while the cabazitaxel plus prednisone group had a reported median of 15.1 months (median means half the participants lived longer than this time, and half did not reach it). For the secondary measures, the reported data shows that the time before the disease showed signs of progressing was 1.4 months in the mitoxantrone group and 2.8 months in the cabazitaxel group. When looking only at participants whose tumours could be directly measured, 4.4% in the mitoxantrone group and 14.4% in the cabazitaxel group showed a recorded tumour response. The time until tumour progression was reported as 5.4 months versus 8.8 months, and the time until PSA levels rose again was 3.1 months versus 6.4 months. A PSA drop of 50% or more was recorded in 17.8% of the mitoxantrone group and 39.2% of the cabazitaxel group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00482274 · results posted 24 August 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 3 participants, all of whom received a treatment called docetaxel (a type of chemotherapy). The trial was designed to look at a specific group of prostate cancer patients whose cancer had returned based on rising levels of a protein called PSA (prostate-specific antigen, a marker measured in the blood), but who had not yet lost their response to hormone treatment. The main thing the trial set out to measure was how many participants reached a "complete response," which was defined as their PSA level dropping to 0.2 ng/ml or below (a very low level). The trial also planned to track how long it took for PSA levels to rise again, how long before the cancer spread, how long before it stopped responding to hormone treatment, and how long participants lived overall. The reported data shows that of the 3 participants who started the trial, 2 completed it and 1 did not. For the main measure, the reported results indicate that 1 out of 3 participants reached the defined complete response level of PSA at or below 0.2 ng/ml. For all of the secondary measures — including time to PSA recurrence, time to cancer spread, time to hormone resistance, and time to death — the reported data shows that no results were recorded. According to the results reported on ClinicalTrials.gov, these analyses were not completed because so few people enrolled in the trial. It is worth noting that only 3 people took part in this trial, which is a very small number. The reported data shows results from just this tiny group, which means the numbers on their own are very limited in what they can tell us about the treatment more broadly. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00056407 · results posted 5 March 2010
According to the results reported on ClinicalTrials.gov, this trial (NCT00056407) enrolled 4,126 people in the placebo group and 4,105 people in the dutasteride 0.5 mg group — just over 8,200 men in total. The trial followed participants for four years and was primarily measuring how many men in each group were found to have prostate cancer detected through biopsy (a procedure where small tissue samples are taken from the prostate and examined). Biopsies were scheduled at years two and four of the study. The reported data shows that, looking across the full four years, 858 participants in the placebo group and 659 in the dutasteride group had biopsy-detectable prostate cancer. Breaking this down by time period: in the first two years, 578 placebo participants and 435 dutasteride participants had cancer detected; in years three and four, the numbers were 280 and 224 respectively. For a secondary measure looking at the "grade" (a scoring system reflecting how abnormal the cancer cells appeared, from low to high), the reported data shows that low-grade cancers (scored 2–6) were detected in 617 placebo participants and 437 dutasteride participants, while higher-grade cancers (scored 7–10) were found in 233 and 220 participants respectively. The most severe category (scores 8–10) was recorded in 19 placebo participants and 29 dutasteride participants. The trial also measured pre-cancerous tissue changes and their volume, with figures reported for both groups, though some detailed breakdowns within those categories were not fully labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.