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The PREVAIL trial was a double-blind phase III study that compared enzalutamide with placebo in 1717 patients with metastatic castration-resistant prostate cancer (CRPC) who had not received prior chemotherapy, explains Kenneth Kernan, MD. The rate of radiographic progression-free survival at 12 months was 65% among patients treated with enzalutamide versus 14% among patients receiving placebo (P < .001). Overall, there was a 29% reduction in risk of death with enzalutamide (P < .001). Time to chemotherapy was 28 months with enzalutamide compared with 10 months in the placebo arm.
Patients and prescribing partners will need to be properly educated on the risks associated with enzalutamide, as an active treatment, suggests Christopher Pieczonka, MD. Once administered, patients on this medication will require continued monitoring for potential side effects, particularly its drug-to-drug interactions. It is also suggested that protocols be established on concomitant medication issues, precautions, lab results, and risk stratification.
Prior to enzalutamide, the FDA approved abiraterone acetate as a treatment for men with mCRPC prior to the administration of chemotherapy. At the final 49.2-month analysis of the COU-AA-302 study that led to this approval, the median overall survival was 34.7 months with abiraterone versus 30.3 months with placebo. It is good to have two options for patients with mCRPC, notes Brian Mehlhaff, MD.