204 Background: 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), insulin resistance, and fasting lipids. Results: 25 men were randomized to MDC, and 23 were randomized to SOC. Overall 91% (295/325) of MDC visits were completed. 72% (18/25) of patients completed all 12 months of MDC, and 80% (20/25) completed the first 6 months. Compared to SOC, patients in the MDC arm had a trend towards more favorable mean percent change from baseline to 12-month follow up in systolic BP (6.5% vs. 10.3%), diastolic BP (-3.9% vs.10.0%), waist circumference (2.5% vs. 4.0%), HbA1C (-2.4% vs. -1.7%), insulin resistance (0.5% vs. 1.9%), and fasting lipids (total cholesterol: 7.0% vs. 21.8%; LDL: -2.9% vs. 7.6%; triglyceride: 15.5% vs. 37.2%). Conclusions: Individualized and comprehensive management of toxicities of ADT in a multidisciplinary clinic is feasible, and appears to provide some benefit over SOC. Larger randomized studies are warranted to investigate whether this intervention will provide lasting benefit. Clinical trial information: NCT02168062.
A Randomized Phase II Study of Androgen Deprivation Therapy with or without Palbociclib in RB-positive Metastatic Hormone-Sensitive Prostate Cancer