A prospective trial of a structured exercise program to lessen fatigue in patients with advanced prostate cancer (aPC) undergoing androgen deprivation therapy (ADT).

120 Background: Cancer-related fatigue, one of the most significant issues affecting quality of life (QOL), is reported by up to 75% of men with advanced prostate cancer (aPC) on ADT. Exercise may serve as a tool to improve fatigue in cancer patients. We examined the effect of a structured exercise program on fatigue in men with aPC. Methods: This prospective trial enrolled participants with aPC treated with an ADT-based regimen on a 12 week exercise program at a single institution. Patients with at least 4/10 tiredness, self-reported sedentary lifestyle (<90 min/week exercise), no evidence of disease progression, and no chemotherapy within 3 months were eligible. Participants underwent peak aerobic capacity, muscular strength and endurance testing before and after 12 weeks of structured, guided exercise through the institution’s hospital-based exercise oncology program called Personal Optimism With Exercise Recovery (POWER). Participants completed symptom questionnaires including the 7-item PROMIS fatigue at baseline and after 6 and 12 weeks. Participants had 45-60 min supervised sessions weekly, either in person or virtually, and were instructed to work up to 150 min of moderate activity and 2 resistance training sessions weekly. The primary endpoint was change in fatigue; a 4 point reduction in T score is a clinically important difference. The key secondary endpoint was change in relative peak aerobic capacity (ml/kg/min). Mean and 95% Gaussian confidence intervals are reported. Results: 119 participants with aPC, 92% of whom had metastatic disease, enrolled between 2018 and 2022. Nine withdrew from the study and 10 were lost to follow-up. Data were incomplete for 28 participants primarily due to inadequate follow-up during COVID. Of the 119 enrolled participants, 96% were white, 83% were married, 52% had at least a college degree, and 25% were currently employed. Mean age was 70.3 years and mean BMI was 30.5 kg/m 2 . 29 participants (24%) were receiving treatment with ADT alone, and the rest were receiving a combination of ADT and targeted therapy. The primary endpoint was evaluable in 72 participants. There was a clinically significant reduction in fatigue of 5.1 points (95%CI 3.6-6.7) between baseline (56.7 [95%CI 55.1-58.0]) and 12 weeks (51.4 [95%CI 49.8-53.1]). Of those who completed both aerobic fitness assessments (n=76), there was a 3.1 ml/kg/min (95%CI 2.1-4.0) improvement in relative peak aerobic capacity from a mean 27.5 [95%CI 25.8-29.2] at baseline to a mean 30.6 [95%CI 28.8-32.3] at 12 weeks. Conclusions: Completion of a 12 week supervised exercise regimen led to a clinically significant improvement in fatigue and peak aerobic exercise capacity. These findings support routinely recommending exercise for and examining symptom management in patients with metastatic cancer to improve QOL. Clinical trial information: NCT03421782 .