Changes Made to Phase 3 Xtandi Trial in Men with Non–Metastatic Castration–Resistant Prostate Cancer

Changes Made to Phase 3 Xtandi Trial in Men with Non–Metastatic Castration–Resistant Prostate Cancer
Astellas Pharma and Pfizer amended the protocol of the international Phase 3 PROSPER trial evaluating Xtandi (enzalutamide) in men with non–metastatic castration–resistant prostate cancer (CRPC). PROSPER is a randomized, double–blind, placebo–controlled trial (NCT02003924) that is evaluating the safety and effectiveness of Xtandi in these patients. Study participants are randomized to 160 mg of Xtandi orally once daily or a placebo. The primary goal of the study, which remains the same, is to assess the effectiveness of the compound by measuring the metastasis–free survival (MFS) of patients after a treatment period of more than 16 weeks. Secondary objectives of the study include the time to prostate–specific antigen (PSA) progression, patients’ overall survival (OS), time to pain progression, time to chemotherapy–free survival, patients’ quality of life, and other efficacy and safety measures. The amendment revises the plan for the analyses of the primary a
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