Neal D. Shore, MD, FACS, discusses the results of the randomized, open label, phase 2 ENACT trial in prostate cancer.
Neal D. Shore, MD, FACS, medical director of the Carolina Urologic Research Center, discusses the results of the randomized, open label, phase 2 ENACT trial (NCT02799745) in prostate cancer.
The ENACT trial randomized patients with clinically localized low- or intermediate-risk prostate cancer 1:1 to receive enzalutamide (Xtandi) monotherapy vs active surveillance. The results of the study, which were presented during the 2021 AUA Annual Meeting, demonstrated that the primary end point of time to pathological or therapeutic prostate cancer progression was met.
Patients receiving enzalutamide had a 46% reduction in the risk of prostate cancer progression compared with patients undergoing active surveillance, Shore says. Additionally, pathological and therapeutic prostate cancer progression were consistent, but the hazard ratios were not statistically significant, and the data set was small, Shore explains.
Additional results revealed that the odds of patients having a negative biopsy at 1 year were 3.5 times higher with enzalutamide vs active surveillance. Moreover, treatment with enzalutamide led to statistically significant reductions in the mean percentage of cancer-positive cores at 1 year, delays in prostate-specific antigen (PSA) progression by 6 months, and reductions in the odds of a secondary rise in serum PSA at 1 year, Shore concludes.