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

This is a PI-initiated, randomized clinical trial of 12 weeks of aerobic exercise vs. 12
weeks of resistance exercise vs. usual care among 39 men with metastatic castration resistant
prostate cancer. Eligible men will be randomized with equal probability to one of the three
regimens. All patients will receive a packet of print material on diet, exercise, and
psycho-social support appropriately geared for men with late stage disease at the end of the
trial. The aerobic exercise arm (N=13) will receive a 3 day/week remotely-supervised exercise
regimen that includes high-intensity interval training and continuous vigorous intensity
aerobic exercise training. The resistance exercise arm (N=13) will receive a 3 day/week
remotely-supervised resistance exercise regimen incorporating different volumes and loads.
Men in the control arm (N=13) will be asked to continue their typical exercise practices for
12 weeks. Subjects will be asked to complete questionnaires, physical function and strength
tests, body measurements, and collection of blood specimen at baseline and 12 weeks.

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 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/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

- Any prior chemotherapy for castrate-resistant disease: 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