Multinational phase 3 trial of enzalutamide, androgen deprivation therapy, or both for biochemically recurrent prostate cancer

Patients with prostate cancer who have high-risk biochemical recurrence have increased risk of progression. The multinational phase 3 EMBARK trial evaluated enzalutamide plus leuprolide, placebo plus leuprolide, or enzalutamide monotherapy in these patients. With respect to metastasis-free survival (primary endpoint), enzalutamide plus leuprolide was superior to leuprolide alone, as was enzalutamide monotherapy. The safety profile of enzalutamide was consistent with what is seen in previous trials, with no apparent detrimental effect on quality of life (quick take video summary).