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

This study investigates the effects of adding cytoreductive radical prostatectomy (CRP) to the standard treatment, best systemic therapy (BST), for metastatic prostate cancer (mPCa). CRP removes as much of the cancer as possible (and radical prostatectomy removes only prostate) while BST uses drugs toxic to cancer cells: chemotherapy and androgen deprivation therapy (ADT: decreases hormones necessary for cancer growth). However, BST eventually stops working. Researchers are trying to find alternatives for better cancel control and longer, effective BST. Theres some evidence that combining CRP + BST may prolong survival for mPCa patients. The target population are men at least 18 years old, with newly diagnosed mPCa, havent received surgery, chemotherapy, or radiotherapy, have been on ADT for no more than six months. Randomization will be into (1/2); Arm 1: subjects receive BST, Arm 2: subjects receive ADT for at least one month prior to CRP. Surgeon will perform a Robotic Assisted Radical Prostatectomy (RARP) or open Retropubic Radical Prostatectomy (RRP), depending on which is best for the subject. Subjects will then begin BST. Tumor samples will be collected for research purposes. During the study, there will be exams, tests, and procedures. Subjects must follow-up every three months to report symptoms, health problems, new medications, receive physical examination, and blood tests. Every other visit, subjects will complete seven quality-of-life based questionnaires to determine urinary, erectile function, and patient satisfaction. Subjects will receive treatment as long cancer is not worsening and is tolerable. Follow-up will continue for the rest of their lives.