Xtandi Reduces Risk of Metastasis in Castration-resistant Prostate Cancer, Phase 3 Trial Shows

Xtandi Reduces Risk of Metastasis in Castration-resistant Prostate Cancer, Phase 3 Trial Shows
Treatment with Xtandi (enzalutamide) reduced the risk of metastasis or death in castration-resistant prostate cancer (CRPC) patients whose cancer has not yet spread beyond the prostate, Pfizer and Japan-based Astellas Pharma recently announced. The Phase 3 PROSPER trial evaluated whether adding Xtandi to the standard androgen deprivation therapy (ADT) was better than ADT alone in patients whose cancer had progressed based on rising PSA levels. The combination extended the time a patient remained alive and metastasis-free by nearly two years, compared to ADT alone. The positive results of the trial led to the submission of marketing applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The study, "PROSPER: A phase 3, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) in men with nonmetastatic castration-resistant prostate cancer (M0 CRPC)," was presented last week at the 2018 Genitourinary Cancers Symposium in San Francisco. Patients with non-metastatic CRPC are those whose prostate cancer worsens despite reduction of the amount of testosterone to very low levels with anti-androgen therapies. “In patients with non-metastatic CRPC, there is a high unmet need to delay development of metastases and the progression
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