Xtandi hits goal in non-metastatic castration-resistant prostate cancer trial
The Phase III PROSPER trial evaluating Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) versus ADT alone in patients with non-metastatic castration-resistant prostate cancer (CRPC) met its primary endpoint of improved metastasis-free survival (MFS).
The preliminary safety analysis of the PROSPER trial appears consistent with the safety profile of Xtandi in previous clinical trials, said the drug’s developers, US pharma giant Pfizer (NYSE: PFE) and Japan’s Astellas Pharma (TYO: 4503).
“Many prostate cancer patients who initiate androgen deprivation therapy will experience disease progression illustrated by a rising PSA level, and currently, there are no FDA-approved treatment options for patients with non-metastatic CRPC until they develop confirmed radiographic metastatic disease,” said Dr Neal Shore, director, CPI, Carolina Urologic Research Center.
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