CHAMP: A Randomized Controlled Trial of High-intensity Aerobic and Resistance Exercise for Metastatic Prostate Cancer (CHAMP)
Prostate Cancer
About this trial
This is an interventional prevention trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically documented adenocarcinoma of the prostate with systemic bone or node metastatic disease despite castrate levels of testosterone (<50 ng/dL) due to orchiectomy or luteinising hormone-releasing hormone (LHRH) agonist. Castrate levels of testosterone must be maintained while on study. Men can be enrolled prior to starting abiraterone and/or enzalutamide OR already be receiving treatment with abiraterone and/or enzalutamide.
- On androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy. All patients will be required to be on ADT throughout the study.
- ≥4 weeks since any major surgery and fully recovered
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Required Initial Laboratory Values:
- Platelet count ≥ 100,000/microliter (uL)
- Hepatic and renal dysfunction that would preclude participation in an exercise program, in the opinion of the treating physician
- Serum testosterone ≤ 50 ng/dL
- Medical clearance to undergo steep ramp test and completion of steep ramp test
- Physician consent to participate in vigorous aerobic or resistance exercise training
- Age ≥18 years
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
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
No Intervention
Experimental: Arm 1 (Aerobic Exercise)
Experimental: Arm 2 (Resist. Exercise)
No Intervention: Arm 3 (Control)
Arm 1 will engage in a periodized program consisting of 3 aerobic exercise sessions per week comprised of two high-intensity interval training workouts and 1 continuous vigorous intensity workout. A physical assessment, physical function and strengths tests, and questionnaires will be completed at baseline and 3 months.
Arm 2 will engage in a periodized program consisting of 3 resistance exercise sessions per week comprised of various loads and volumes. A physical assessment, physical function and strengths tests, and questionnaires will be completed at baseline and 3 months.
Arm 3 will follow their usual exercise and lifestyle routine. A physical assessment, physical function and strengths tests, and questionnaires will be completed at baseline and 3 months.