Adding Xtandi (enzalutamide) to hormone therapy reduces the risk of cancer spreading in patients with non-metastatic castration-resistant prostate cancer (CRPC), new Phase 3 trial data shows. Additional results announced by Pfizer and Astellas Pharma, the drug developers, also show that the safety profile of Xtandi in this population is consistent with previous clinical trials. “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,” Dr. Neal Shore, MD, director, Carolina Urologic Research Center, said in a press release. Pfizer and Astellas initiated the multinational PROSPER trial (NCT02003924) to determine the effects of Xtandi in men with non-metastatic CRPC. The trial enrolled approximately 1,400 patients with prostate cancer that had progressed, based on rising PSA levels, despite androgen deprivation therapy (ADT) but with no symptoms or other evidence of metastasis. Participants were randomly assigned Xtandi plus hormone therapy or a placebo plus hormone therapy. The study's primary endpoint was metastasis-free survival, which is the amount of time passed until the cancer spread. “We are delighted with the significant results seen in the PROSPER study, showing that Xtandi plu