A prospective trial of a personalized exercise program in patients with advanced prostate cancer.

BACKGROUND: The majority of patients with advanced prostate cancer (aPC) receiving androgen deprivation therapy (ADT) report fatigue as a major contributor to impaired quality of life (QOL). Herein, we evaluated the effect of a structured exercise program on fatigue in aPC. METHODS: Patients with aPC receiving ADT-based therapy were enrolled in a prospective clinical trial evaluating the impact of a 12-week, hospital-based, oncology-focused structured exercise program on fatigue. Eligibility criteria included receipt of hormone-therapy-based regimen for at least 4 weeks prior to enrollment, ≥4/10 tiredness in the prior week, sedentary lifestyle, no disease progression, and no chemotherapy within 3 months. Participants participated in weekly supervised 45-60-minute sessions either in person or via telemedicine and were encouraged to achieve ≥ 150 minutes of unsupervised moderate-intensity aerobic exercise per week, and to perform resistance exercises twice per week. Peak aerobic capacity, muscular strength/endurance, and symptom questionnaires were assessed at baseline and 12 weeks. The primary endpoint was change in PROMIS Fatigue 7a T-score; the key secondary endpoint was change in relative peak aerobic capacity. RESULTS: A total of 119 participants were enrolled. Of the 72 participants evaluable for the primary endpoint, there was a clinically significant 5.1-point reduction in fatigue (95% CI 3.6-6.7) by 12 weeks. Of the 76 participants who completed both aerobic fitness assessments, there was a 3.1 ml/kg/min (95% CI 2.1-4.0) clinically significant improvement in relative peak aerobic capacity by 12 weeks. CONCLUSIONS: Completion of a 12-week exercise program led to clinically significant improvements in fatigue and exercise capacity in patients with aPC. These findings support routine recommendation of exercise for fatigue management in patients with aPC. (ClinicalTrials.gov identifier NCT03421782).