Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from 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 to sign and date a consent form agreeing to take part in the study.
• People who are willing and able to follow all study procedures for the full duration of the trial.
• Biologically male patients aged 18 years or older.
• People who are able to receive radiation therapy to the pelvic area and are willing to follow the treatment plan outlined in the study.
• People whose prostate cancer has not previously been treated with chemotherapy, freezing therapy, ablation, surgery, or radiation — though a prior procedure to remove tissue from the urethra (called a TURP) is allowed if it was done at least 90 days before radiation starts.
• People with localised or locally advanced prostate cancer that meets recognised high-risk criteria, which may include a PSA level above 20 ng/mL before hormone therapy started, a tumour that has grown beyond the prostate based on physical exam or imaging, a Gleason score of 8–10 (grade group 4 or 5), or cancer that has spread to nearby pelvic lymph nodes but not to distant parts of the body.
• People who have had a full physical examination and health history review within 120 days before enrolling in the trial.
• People with a general health and activity level rated as ECOG 0–2, meaning they are fully active, have some limitations but can care for themselves, or are up and about for more than half of waking hours (confirm with trial site).
• People who are able to have an MRI scan of the prostate and/or pelvis as part of radiation treatment planning.
• People who have at least one area visible on MRI that can be targeted with a focused radiation boost, rated PI-RADS 4 or higher (confirm with trial site).
• People who have had appropriate bone and soft tissue imaging for cancer staging within 120 days before enrolling.
• People who agree to use condoms or other reliable contraception with a partner during radiation treatment and for six months after it ends.
• People whose recent blood test results show adequate blood cell and platelet levels, without relying on a recent transfusion (haemoglobin at least 9.0 g/dL and platelets at least 100,000).
• People whose recent blood test results show that their liver is functioning adequately, based on bilirubin levels within acceptable limits.
• People who are willing and medically suitable to receive long-term hormone therapy (androgen deprivation therapy, lasting 12 to 36 months) as part of standard prostate cancer treatment.

Who may not be able to join:

• People who are currently using testosterone supplements, unless these have been stopped before enrolling.
• People whose imaging clearly shows cancer has spread to areas outside the pelvic lymph nodes, such as bones or other organs.
• People who have previously had radiation therapy to the pelvic area.
• People whose overall health or pre-existing conditions mean that radiation aimed at curing the cancer would not be appropriate, including people with a life expectancy of less than 5 years.
• People who have received another experimental prostate cancer treatment within the past 12 months.
• People who have previously had their prostate fully removed, or who have undergone any ablation procedure targeting the prostate, such as cryotherapy, high-intensity focused ultrasound, or similar treatments.
• People with a history of, or a current, invasive cancer in the pelvic area or a blood or lymph system cancer, unless they have been free of that cancer for at least 5 years (skin cancers that are not melanoma are generally acceptable).
• People who, in the opinion of the trial doctors, have any condition that would make participation unsafe or unsuitable.
• People who have already started hormone therapy (androgen deprivation) for prostate cancer more than 90 days before enrolling in the trial.
• People who are unable to have gold marker seeds or a gel spacer implanted near the prostate (these are used to guide radiation treatment precisely).
• People with another current or past cancer whose history or required treatment could affect the ability to properly assess the safety or effectiveness of this trial's treatment.

Important: Always verify eligibility with the trial site directly before applying.