Dr. Shore on the Rationale for the Phase 2 ENACT Trial in Prostate Cancer

Neal D. Shore, MD, FACS, director, CPI, Carolina Urologic Research Center, US Chief Medical Officer of Surgery and Oncology, GenesisCare USA, discusses the rationale for the open-label, randomized phase 2 ENACT trial (NCT02799745) in prostate cancer. 

The ENACT trial was developed in the context of recognizing few other studies were assessing a therapeutic intervention that could delay progression while patients with prostate cancer were receiving active surveillance, Shore explains. Whether a patient undergoes a prostatectomy, radiation therapy, or focal therapy, the therapies are interventional and confer associated potential morbidity, Shore says. Moreover, these therapies can cause changes in voiding and sexual function.

Enzalutamide (Xtandi) has been FDA approved for men with castration-resistant and castration-sensitive prostate cancers, Shore continues. The mechanism of action, efficacy, and safety profile of enzalutamide are allknown; however, it is important to ask how the agent could but utilized in the active surveillance population. It could have a positive effect on patients with clinically localized low- or intermediate-risk disease, so enzalutamide was evaluated in comparison with active surveillance, Shore concludes.