Phase II Trial of Targeted Radiotherapy to Metastatic Sites in Men With Hormone-Sensitive Metastatic Prostate Cancer Who Responded to Systemic Therapy

What this Trial Is About

Researchers are evaluating a new approach for men with hormone-sensitive metastatic prostate cancer who have responded to systemic therapy and have no PSA progression. This phase II randomized trial is embedded within an ongoing cancer radiotherapy registry and aims to see if adding metastasis-directed radiotherapy MDRT to standard systemic therapy can improve outcomes such as PSA response and failure-free survival. Participants will be randomly assigned either to receive MDRT targeting metastatic sites visible on PSMA-PET scans after starting systemic therapy, or to continue with standard systemic therapy alone, with or without standard radiotherapy if needed. If after the initial MDRT the PSA level remains above 0.2 ngmL at 3 months, a repeat PSMA-PET scan will be done and a second MDRT course will be offered to consolidate residual disease. Throughout the study, patients will be followed for oncologic outcomes and side effects. Key measurements include PSA response at 12 months and failure-free survival over 3 years, with additional assessments of quality of life, toxicity, and time to progression extending up to 5 years. The study is open-label, with neither patients nor doctors blinded to treatment assignment, and will continue until July 2030.

Ablative Radiotherapy to Consolidate Maximal Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate)