Study Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse

To join this study, men generally need to be between 18 and 80 years old and have a confirmed diagnosis of prostate cancer. Their cancer must be considered 'high-risk,' which means it has specific features, like a high Gleason score, a larger tumour, or a high PSA level, making it more likely to spread.

There are also some health checks. Participants need to be generally well and able to get around, with a good overall health status and no major health problems that would prevent them from completing the study. Blood tests will be done to ensure their liver, kidney, and blood counts are within healthy limits.

However, some men won't be able to join. This includes anyone whose prostate cancer has already spread to other parts of the body, including lymph nodes, or if they have certain other medical conditions. The study team will review all your medical information carefully to see if it's right for you.

If you join this study, you'll be randomly assigned to one of four treatment groups, like flipping a coin, so neither you nor your doctor can choose the group. All groups will receive a common treatment: ADT (hormone therapy) and radiation to the pelvic lymph nodes. Some groups will also receive an additional drug (darolutamide), while others will receive a different, more focused type of radiation to the prostate (SBRT), or a combination of both.

Your systemic treatments (ADT and/or darolutamide) will typically last for two years. During this time, you'll have regular check-ups at the hospital. These visits are planned for around day 45, day 90, day 180, and then every three months. At these appointments, the doctors will check your general health, measure your PSA levels, and monitor how you're responding to treatment. You'll continue to be followed up after this initial period for several years to see how effective the treatments are in the long term, especially in preventing the cancer from spreading. Imaging scans will be used if there are signs of the cancer potentially returning or spreading.