Phase 3 Prostate Cancer Trial, Recruiting

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 have been diagnosed with prostate cancer confirmed by a tissue biopsy and have had their prostate surgically removed (radical prostatectomy), including those who did not have lymph nodes removed during that surgery.
• People whose PSA blood test levels have risen again after surgery, indicating the cancer may be returning — specifically, a PSA of 0.2 ng/mL or higher, confirmed by a second test at least two weeks later showing the level has risen further. People with certain higher-risk features (Gleason score 8–10, pT3b, or positive surgical margins/R1) may be considered with a slightly lower PSA threshold of 0.15 ng/mL or above (confirm with trial site).
• People who fall into the "intermediate" or "high" risk categories based on a specific scoring system that considers factors such as PSA level at diagnosis, how quickly PSA is doubling, tumour grade (Gleason/ISUP score), tumour stage, time until PSA rose again after surgery, and whether surgical margins were positive.
• People whose testosterone level is above 150 ng/dL at the time of joining.
• People who are in good general health, able to carry out normal daily activities with little or no limitation (ECOG performance score of 0 or 1).
• People with a life expectancy of more than 5 years.
• People who have read and signed an informed consent form agreeing to take part.

Who may not be able to join:

• People whose original surgical specimen showed cancer had spread to the lymph nodes (pN1 disease).
• People whose imaging scans show visible, measurable cancer remaining or returning — imaging is required if PSA at diagnosis was above 0.4 ng/mL.
• People whose PSA level is below the required threshold — below 0.2 ng/mL in general, or below 0.15 ng/mL for those with specific higher-risk features (Gleason 10, pT3b, or positive surgical margins).
• People who have previously had radiotherapy to the pelvic area.
• People for whom radiotherapy is medically unsuitable or contraindicated for any reason.
• People currently receiving hormone therapy (ADT) or medications that affect PSA levels, such as finasteride, dutasteride, or high-dose steroids.
• People who are unable to understand the treatment protocol or are unable to provide signed informed consent.

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