Intense exercise for survival among men with metastatic castrate-resistant prostate cancer (INTERVAL – MCRPC): A Movember funded multicenter, randomized, controlled phase III study.

TPS5092Background: Provocative evidence supports the beneficial role of physical activity on prostate cancer survivorship. Evaluating exercise as a low-toxicity adjuvant intervention that can be combined with standard therapy to improve outcomes in men with prostate cancer could reduce the clinical and public health burden of the disease. Exercise may affect prostate cancer survival via inflammation, hormonal, and energy metabolism pathways. Methods: Our goal is to compare overall survival (OS) among men with MCRPC randomly assigned to psychosocial support +/- high intensity aerobic and resistance training for 24 months. Secondary outcomes include: time to disease progression, occurrence of a skeletal-related event, or progression of pain; and degree of pain, opiate use, and physical and emotional quality of life. We will assess if inflammation, dysregulation of insulin and energy metabolism, and androgen biomarkers are associated with OS, and if they mediate the primary association between exercise and O...