SIMCAP (Surgery in Metastatic Carcinoma of Prostate): phase 2.5 multi-institution randomized prospective clinical trial evaluating the impact of cytoreductive radical prostatectomy combined with best systemic therapy on oncologic and quality of life outcomes in men with newly diagnosed metastatic prostate cancer

INTERVENTION: cytoreductive prostatectomy systemic therapy alone CONDITION: metastatic prostate cancer PRIMARY OUTCOME: The primary endpoint for the Phase 2 portion of this study is the failure‐free survival (FFS) rate at two years after randomization. Failure is defined as: biochemical recurrence, clinical progression, or death from prostate cancer. SECONDARY OUTCOME: There are seven secondary endpoints: 1) % PSA nadir < 0.2 ng/ml at six months after randomization, 2) overall complication rate, 3) time to biochemical progression, 4) time to clinical progression, 5) FFS (primary endpoint for phase 2 portion), 6) cancer‐specific survival, and 7) overall survival (primary endpoint for phase 3 portion). Overall survival will switch to the primary endpoint if the study converts successfully to phase 3 trial. INCLUSION CRITERIA: