A multidisciplinary team-based approach to mitigate the impact of androgen deprivation therapy in prostate cancer: A randomized phase II study.

204Background: Androgen deprivation therapy (ADT) is associated with numerous metabolic toxicities that are potentially modifiable. We sought to evaluate the impact of participation in a multidisciplinary clinic (MDC) designed to provide individualized lifestyle modification and management of ADT-related side effects. Methods: This phase II study recruited men with prostate cancer who had started ADT < 6 months prior to enrollment, and in whom ADT was planned for at least 12 months following enrollment. Patients were randomized in a 1:1 ratio to either the MDC or standard of care (SOC). Patients randomized to the MDC were provided monthly multidisciplinary assessment and counseling on exercise, nutrition, and symptom management for 12 months on a rotating schedule. Endpoints included feasibility endpoints (proportion of visits completed), and efficacy endpoints, including mean change from baseline to 12 months in blood pressure (BP), weight, waist circumference, percent body fat, hemoglobin A1C (HbgA1C), ...