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# Xtandi Wins on Overall Survival in PROSPER Trial
- URL: https://www.fdaweb.com/xtandi-wins-on-overall-survival-in-prosper-trial/
- Published: 2020-02-11T12:00:00.000Z
- Updated: 2026-09-14T16:02:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146067

Pfizer and Astellas Pharma report that the Phase 3 PROSPER trial demonstrated a statistically significant improvement in overall survival (OS) in men with non-metastatic castration-resistant prostate cancer who were treated with Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) versus placebo plus ADT. OS was a key secondary endpoint in the trial. In 2018, the companies announced that the PROSPER trial met its primary endpoint of metastasis-free survival (MFS). In a preliminary analysis, adverse events were generally consistent with those previously reported from PROSPER, the companies say. Detailed efficacy and safety results from the final analysis will be shared at a later date.

Xtandi is an androgen receptor inhibitor indicated for treating patients with castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. PROSPER efficacy and safety data at the time of the MFS analysis are included in the XTANDI labels in the U.S., Europe and Japan.