Phase 2 Randomized Trial: Best Systemic Therapy With Definitive Primary Tumor Treatment in Metas

In this study of a well-selected de novo M1 population, we demonstrated the feasibility and safety of randomizing men with de novo M1 prostate cancer treated with the best systemic therapy, with the addition of surgery or radiation to their primary tumor. This study did not demonstrate improvement in progression-free survival when local therapy was added to systemic treatment for metastatic prostate cancer. We identified the aggressive variant prostate cancer signature as a biomarker of prognostic value that may serve to optimize therapy selection in the metastatic population.