Xtandi Significantly Improves Overall Survival in Men with High-risk CRPC, Phase 3 Final Data Show

Xtandi Significantly Improves Overall Survival in Men with High-risk CRPC, Phase 3 Final Data Show
Treatment with Xtandi (enzalutamide) significantly extends the lives of men with high-risk, non-metastatic castration-resistant prostate cancer (CRPC), according to final data from a Phase 3 clinical trial. Developed by Pfizer and Astellas Pharma, Xtandi is an oral hormone therapy that works by blocking the interaction between male hormones and their receptors in cancer cells. Since this interaction can stimulate prostate cancer growth, Xtandi is expected to halt cancer progression in these patients. The therapy is currently approved in the U.S. and in Europe for the treatment of three types of advanced prostate cancer: high-risk non-metastatic CRPC, metastatic CRPC, and metastatic castration-sensitive prostate cancer (mCSPC). Xtandi’s approval for treating men with high-risk non-metastatic CRPC was based on positive data from the Phase 3 PROSPER clinical trial (NCT02003924). PROSPER was designed to assess whether adding Xtandi to standard androgen deprivation therapy (ADT) was superior to ADT alone in 1,401 men with non-metastatic CRPC and rising prostate-specific antigen (PSA) levels. PSA levels are a marker of disease progression. The patients had no symptoms or other evidence of metastasis. The participants were randomly assigned to receive either 160 mg of Xtandi (933 patients) or a placebo (468 patients) orally, in addition to standard therapy. The trial’s primary goal was metastasis-free survival, or the time a patient lives without cancer spreading or until death from any cause. Secondary goals included time to PSA progression and to first use of a subsequent anti-cancer chemotherapy, patients’ overall survival, and safety. Interim results at an earlier data cut-off date in June 2017 showed that adding Xtandi to ADT signific
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