Enzalutamide is an androgen-receptor inhibitor that has been associated with improved overall survival rates in men with castration-resistant prostate cancer. The objective of this study is to assess the efficacy of enzalutamide with standard first-line therapy in men with metastatic prostate cancer.
This is an open-label, randomized, phase-3 trial conducted on a total of 1,125 men with castration-resistant prostate cancer. The participants were randomly assigned to receive testosterone suppression in combination with either open-label enzalutamide or a standard non-steroidal antiandrogen therapy. The primary outcome of the study was overall survival, along with progression-free survival and adverse events.
A total of 102 deaths were reported in the enzalutamide group and 143 deaths in the standard-care group. The overall survival at 3 years was 80% for the enzalutamide group and 72% for the standard-care group. The enzalutamide group also reported better outcomes in progression-free survival. However, treatment discontinuation due to adverse events was more common in the enzalutamide group than in the standard care group. The most common adverse events were fatigue and seizures.
The research concluded enzalutamide resulted in a significantly longer overall and progression-free survival than the standard care group. But enzalutamide treatment was also linked to an increased risk of side effects, such as seizures and fatigue.