Phase II Trial Comparing Stereotactic Body Radiotherapy and Standard Systemic Therapy Change for Men With Oligoprogressive Castrate Resistant Prostate Cancer

What this Trial Is About

Researchers are investigating a treatment approach for men with oligopressive castrate-resistant prostate cancer, a type of prostate cancer that continues to grow despite hormone therapy. This randomized Phase II trial compares the effects of stereotactic body radiotherapy SBRT targeting all sites of oligopressive disease while continuing current systemic therapy, versus the standard of care which usually involves changing systemic therapy. The study aims to determine if SBRT can improve biochemical control of the cancer and maintain quality of life while avoiding side effects related to changing systemic treatments. Participants are randomly assigned to one of two groups. In the standard of care group, patients typically change their systemic therapy under their oncologists guidance and may receive palliative radiotherapy as needed. In the experimental group, patients continue their current systemic therapy and receive SBRT to treat all identified oligopressive metastatic sites according to institutional standards. The trial includes an initial feasibility phase followed by a larger phase II study. During the study, participants will be monitored through regular assessments including changes in prostate-specific antigen PSA levels and imaging to evaluate local and distant control of metastatic lesions. Researchers will also track progression-free survival, time until next systemic therapy, treatment-related toxicities, and quality of life over a 12-month period after enrollment. The total study duration extends up to June 2030, with ongoing evaluation of safety and treatment outcomes.

Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer