Exercise Intervention for Pts With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or Enzalutamide

This randomized pilot study will be conducted in men with metastatic castration resistant
prostate cancer (mCRPC) within 3 months of initiating abiraterone or enzalutamide. The
purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in
mCRPC patients who have recently started on additional androgen suppression therapy. The
investigators will also explore the effects of the exercise training on biomarkers of
inflammation-hormonal status and their potential association with changes in lean mass and
function.

Inclusion Criteria:

1. ≥18 years of age

2. Metastatic disease that has progressed despite castrate levels of testosterone
(surgically or medically castrated, with testosterone levels of < 50 ng/dL)

3. No prior chemotherapy

4. Initiated therapy with either abiraterone plus a glucocorticoid or enzalutamide
within the 3 months prior to randomization

5. Ability to engage safely in moderate exercise as determined by their treating
physician

6. Not previously engaged in regular exercise training (>1-2 d/wk for > 30 min/d) in the
past 6 months

7. Be able to speak and read English

Exclusion Criteria:

1. Any condition that causes severe pain with exertion

2. History of bone fractures

3. Active cardiovascular disease including any of the following:

- New York Heart Association (NYHA) Grade II or greater congestive heart failure

- History of myocardial infarction or unstable angina within 6 months prior to Day
1

- History of stroke or transient ischemic attack within 6 months prior to Day 1

4. Acute or chronic respiratory disease

5. Acute or chronic bone/joint/muscular abnormalities compromising their ability to
exercise

6. Neurological conditions that affect balance and, or muscle strength

7. Dementia, altered mental status or any psychiatric condition prohibiting the
understanding or rendering of informed consent