Phase 2 Prostate Cancer Trial, RecruitingNCT05393791Sponsor: Leiden University Medical CenterCondition: Prostate Cancer
Printed from Voxsanity (voxsanity.com.au) — NCT05393791 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
AI generated eligibility 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
Who might be able to join this trial:
People who are willing and able to give their informed consent to participate
People aged 18 or older
People who have been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer), confirmed through a tissue or cell sample
People who are currently receiving hormone therapy to lower testosterone (either through medication or surgical removal of the testicles), with testosterone levels at or below a certain low level at the time of screening
People whose prostate cancer has spread to other parts of the body, confirmed by bone scan and/or CT scan
People whose cancer has continued to grow or spread despite hormone therapy, shown by rising PSA levels over time and/or new or worsening areas on scans
People with a PSA level of 2 ng/mL or higher
People with a general health status rated as 0, 1, or 2 on a standard medical scale (meaning able to carry out daily activities with no more than moderate limitation) (confirm with trial site)
People whose cancer-related pain is stable and well-controlled, with no urgent need for radiation treatment
People with an estimated life expectancy of at least 12 months
People who have stored prostate cancer tissue available to share, or who are willing to have a new tumour biopsy taken
People whose blood counts, liver function, kidney function, and other organ measures fall within acceptable ranges as determined by blood tests (confirm with trial site)
People who have stopped any other prostate cancer treatments (except bone-protecting medications such as denosumab or bisphosphonates) at least 3 weeks before joining the trial
People who are able to swallow the trial medication and follow the trial requirements
Who may not be able to join:
People with a serious medical or psychiatric condition that the trial doctor believes could interfere with participation
People who have been diagnosed with or treated for another type of cancer (other than certain skin cancers, a specific type of bladder cancer, or carcinoma in situ that has been fully removed) within the past 2 years
People with known or suspected cancer that has spread to the brain or the lining around the brain or spinal cord
People whose prostate cancer has a specific cell type known as small-cell or neuroendocrine (confirm with trial site)
People who have had radiation treatment to the prostate tumour itself within 3 weeks before the screening visit
People who have had radiation or radioactive therapy to treat cancer spread (metastases) within 3 weeks before screening, unless it was given only to relieve pain
People with a history of uncontrolled seizures, if they and their doctor are considering a specific trial medication called enzalutamide
People with unstable heart conditions, including certain types of irregular heartbeat or significant heart failure
People with a known HIV infection, or active hepatitis B or C infection
People with a known gut or digestive condition that could affect how the trial medication is absorbed
People who have previously been treated with certain hormone-blocking medications, including abiraterone, apalutamide, darolutamide, enzalutamide, or ketoconazole (note: prior treatment with docetaxel for earlier-stage prostate cancer is allowed)
People with any other condition or situation that the trial doctor believes would make participation unsafe or unsuitable
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Tom van der Hulle, MD, Leiden University Medical Center
Border Medical Oncology Research Unit / The Border Cancer Hospital, Albury, New South Wales
Chris O'Brien Lifehouse, Camperdown, New South Wales
+61 2 8514 0194
St George Hospital, Kogarah, New South Wales
+61 2 9113 1111
Calvary Mater Newcastle, Newcastle, New South Wales
+612 40143282
Genesis Care North Shore, St Leonards, New South Wales
+61 474 164 541
Sydney Adventist Hospital, Wahroonga, New South Wales
+61 2 9480 6280
Sunshine Coast University Hospital, Birtinya, Queensland
+61752020651
Mater Hospital Brisbane, South Brisbane, Queensland
Royal Adelaide Hospital, Adelaide, South Australia
+6170742336
ICON Cancer Centre, Adelaide, South Australia
+61884740220
Eastern Health Box Hill, Box Hill, Victoria
+61390952465
Fiona Stanly Hospital, Murdoch, Western Australia
+61 8 6152 6530
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Voxsanity
Clinical trials and treatments, explained plainly · voxsanity.com.au
Date:
To: My Doctor
Re: Clinical trial enquiry
I am writing to enquire about the following clinical trial which may be relevant to my care:
Trial: NCT05393791
Sponsor: Leiden University Medical Center
Phase: Phase 2
Status: Recruiting
Condition: Prostate Cancer
Trial contact: 0031715263464
More information: https://clinicaltrials.gov/study/NCT05393791
Eligibility summary (AI generated)
Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
People who are willing and able to give their informed consent to participate
People aged 18 or older
People who have been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer), confirmed through a tissue or cell sample
People who are currently receiving hormone therapy to lower testosterone (either through medication or surgical removal of the testicles), with testosterone levels at or below a certain low level at the time of screening
People whose prostate cancer has spread to other parts of the body, confirmed by bone scan and/or CT scan
People whose cancer has continued to grow or spread despite hormone therapy, shown by rising PSA levels over time and/or new or worsening areas on scans
People with a PSA level of 2 ng/mL or higher
People with a general health status rated as 0, 1, or 2 on a standard medical scale (meaning able to carry out daily activities with no more than moderate limitation) (confirm with trial site)
People whose cancer-related pain is stable and well-controlled, with no urgent need for radiation treatment
People with an estimated life expectancy of at least 12 months
People who have stored prostate cancer tissue available to share, or who are willing to have a new tumour biopsy taken
People whose blood counts, liver function, kidney function, and other organ measures fall within acceptable ranges as determined by blood tests (confirm with trial site)
People who have stopped any other prostate cancer treatments (except bone-protecting medications such as denosumab or bisphosphonates) at least 3 weeks before joining the trial
People who are able to swallow the trial medication and follow the trial requirements
Who may not be able to join:
People with a serious medical or psychiatric condition that the trial doctor believes could interfere with participation
People who have been diagnosed with or treated for another type of cancer (other than certain skin cancers, a specific type of bladder cancer, or carcinoma in situ that has been fully removed) within the past 2 years
People with known or suspected cancer that has spread to the brain or the lining around the brain or spinal cord
People whose prostate cancer has a specific cell type known as small-cell or neuroendocrine (confirm with trial site)
People who have had radiation treatment to the prostate tumour itself within 3 weeks before the screening visit
People who have had radiation or radioactive therapy to treat cancer spread (metastases) within 3 weeks before screening, unless it was given only to relieve pain
People with a history of uncontrolled seizures, if they and their doctor are considering a specific trial medication called enzalutamide
People with unstable heart conditions, including certain types of irregular heartbeat or significant heart failure
People with a known HIV infection, or active hepatitis B or C infection
People with a known gut or digestive condition that could affect how the trial medication is absorbed
People who have previously been treated with certain hormone-blocking medications, including abiraterone, apalutamide, darolutamide, enzalutamide, or ketoconazole (note: prior treatment with docetaxel for earlier-stage prostate cancer is allowed)
People with any other condition or situation that the trial doctor believes would make participation unsafe or unsuitable
Important: Always verify eligibility with the trial site directly before applying.
Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 15 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
Trial details
Status
Recruiting
Phase
Phase 2
Sponsor
Leiden University Medical Center
Registry
ClinicalTrials.gov
Start date
10 November 2022
Est. completion
10 November 2027
Where this trial is recruiting
🇦🇺 Australia
🇳🇱 Netherlands
12 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Time to treatment failure
Can't join this trial?
Expanded access pathways
If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.