CHAMP: A Randomized Controlled Trial of High-intensity Aerobic and Resistance Exercise for Metastatic Prostate Cancer

Exclusion Criteria

• •Men with small cell neuroendocrine tumors or features of small cell disease
• •Chemotherapy criteria: Metastatic castrate-resistant prostate cancer (CRPC) pre-chemo (metastatic castration-resistant adenocarcinoma prostate cancer, pre-CRPC chemotherapy), which is given for hormone-sensitive prostate cancer, is allowed. Metastatic CRPC post- chemo (metastatic castrate-resistant adenocarcinoma prostate cancer, post-CRPC chemotherapy) is allowed with the treating physician's (oncologist) discretion/approval.
• •Poorly controlled hypertension
• •Any contraindications to vigorous exercise, including, but not limited to: brain metastases, current congestive heart failure, serious or non-healing wound, and no serious cardiovascular events within 12 months
• •Experiences shortness of breath, chest discomfort, or palpitations when performing activities of daily living (can participate with cardiologist clearance)
• •Has difficulty climbing a flight of stairs due to physical impairment
• •Has been recommended by a doctor to only medically supervised activity
• •Has chest pain brought on by physical activity (can participate with cardiologist clearance)
• •Has developed chest pain in the past month (can participate with cardiologist clearance)
• •Serious or non-healing wound, ulcer, or bone fracture
• •Spinal cord compromise or instrumentation due to metastatic disease. Radiation therapy for metastatic disease is allowed.
• •Serious or non-healing wound, ulcer, or bone fracture.
• •Spinal cord compromise or instrumentation due to metastatic disease. Radiation therapy for metastatic disease is allowed.
• •Any peripheral neuropathy ≥grade 3
• •Moderate-to-severe bone pain (i.e., National Cancer Institute's Common Terminology Criteria for Adverse Events grade 2-3 bone pain).
• •Men participating in vigorous aerobic exercise for 75 minutes or more per week and/or resistance exercise three or more days per week
• •Men who do not complete the baseline lifestyle and quality-of-life questionnaires