Phase 3 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:

• A diagnosis of prostate cancer (adenocarcinoma type) confirmed by a tissue sample (biopsy).
• The original prostate tumour has already been treated and is under control.
• A rise in PSA (a prostate-related protein measured in the blood) after surgery to remove the prostate followed by radiotherapy, or a PSA rise of a specific amount above its lowest recorded level after high-dose radiotherapy, indicating the cancer may be returning.
• A small number of cancer spots returning in the body — no more than 5 in total, not including the brain, as seen on a specialised PSMA PET scan. Lymph node involvement in the pelvis may be included only when cancer has also spread to other areas of the body, as long as the total number of spots remains 5 or fewer.
• Testosterone levels in the normal range (not at very low/castration levels).
• A general health status rated 0–2 on the WHO performance scale, meaning the person is able to carry out daily activities with at most some limitations (confirm with trial site).
• Age 18 years or older.
• No psychological, social, or location-related circumstances that could make it difficult to follow the trial schedule.
• The case must be reviewed and approved by a multidisciplinary medical team before joining.
• Written consent provided before any screening takes place.
• Use of a highly effective form of contraception throughout the trial treatment period (for example, implants, injections, combined oral contraceptives, certain IUDs, complete abstinence from heterosexual intercourse, or a vasectomised partner).

Who may not be able to join:

• A medical condition that, in the investigator's opinion, could put the participant's safety at risk or make it difficult to follow the trial.
• A current or previous treatment that could affect the participant's safety or interfere with the trial's results.
• Current participation in another clinical trial involving an experimental medicine or medical device.
• Testosterone levels at castration level (very low, as seen with hormone-suppressing treatment).
• A rising PSA while currently receiving hormone-related treatments (such as LHRH agonists or antagonists, anti-androgens, or oestrogen therapy).
• More than 5 metastatic lesions (spots where cancer has spread) in the body.
• Another active cancer (other than prostate cancer) that could affect how trial results are interpreted.
• Previous surgery or radiotherapy, or existing health conditions, that would make the planned SBRT (a precise form of radiotherapy) impossible to deliver safely.
• Conditions that prevent use of the drug enzalutamide — these include a history of seizures or conditions that increase seizure risk, or significant heart or blood vessel problems in the past three months (such as a heart attack, unstable chest pain, heart failure, certain heart rhythm problems, or a blood clot).
• Difficulty understanding the treatment plan, or inability to sign a consent form.

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