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

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