(UroToday.com) The MANSMED trial was designed to investigate the impact of adding Metformin to androgen deprivation therapy in either high-risk localized prostate cancer or metastatic castration-sensitive prostate cancer. This is a randomized, single-blinded trial that includes patients regardless of a diagnosis of diabetes (though all patients had not taken metformin). Patients were randomized 1:1 to either standard of care testosterone suppression +/- antiandrogen + docetaxel when appropriate for metastatic disease. External beam radiation therapy was administered to patients with localized disease or regional disease. The primary endpoint was time to progression to CRPC, with secondary endpoints of safety, overall survival, and PSA response rate.

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