Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study

This study is looking for men aged 18 or older who have been diagnosed with prostate cancer. This cancer must have spread to a few, limited areas in their bones or other soft tissues of the body, but it's still manageable with hormone treatments. You would have had a specific scan (like a PSMA PET scan) recently to show these areas.

To join, you must have already had previous treatments for your prostate cancer that aimed to cure it, such as surgery (prostatectomy) or radiation therapy to the prostate area. You also need to be generally well enough to take part in the study, as assessed by a quick health check.

However, if your cancer has spread very widely, or if you haven't received prior curative-intent treatment for your prostate, this study might not be suitable for you.

If you decide to join this study, your involvement would last for about six months of active treatment, with follow-up appointments afterwards. You would be randomly assigned to one of two groups. One group will take a placebo (a dummy pill that looks like the real drug but contains no active medicine) every day for about six months. The other group will take relugolix every day for the same period. Both groups will also receive their usual radiation therapy, which typically lasts for 1 to 3 weeks.

Throughout the study, you'll have various tests and scans, such as bone scans, CT scans, and special PET scans, to monitor your cancer and check how you're responding to treatment. You'll also answer questionnaires about your health and how you're feeling, including questions about your sexual health and general well-being. These assessments will help the study team understand the effects of the treatment and manage any side effects. You'll have regular clinic visits, and the study will oversee your progress and health for an extended period.