Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer

The purpose of this trial is to evaluate the feasibility and adherence to a home-based 12
week exercise intervention in mCRPC patients receiving ADT. It will also examine if a
home-based exercise intervention can improve muscle strength, body composition, physical
function, cardiopulmonary function fatigue, and patient reported outcomes (fatigue,
depression, quality of life (QoL)). Finally, the effects of the exercise training on
biomarkers of inflammation and hormonal status and their potential association with changes
in body composition, physical function, fatigue, depression, and QoL will be explored.

Inclusion Criteria:

- Metastatic disease that has progressed despite castrate levels of testosterone
(surgically or medically castrated, with testosterone levels of < 50 ng/dL) receiving
ADT. This will be verified by assessing total testosterone levels within 4 weeks prior
to enrollment.

- No current chemotherapy.

- Patients may be receiving additional hormonal therapy agents including but not limited
to antiandrogens (e.g. bicalutamide, enzalutamide) and CYP17 inhibitors (e.g.
abiraterone).

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

- Not previously engaged in regular exercise training (<3 or more d/wk for > 30 min/d or
<90 mins per week total including strength training, aerobic training, or walking) in
the past 6 months.

- Access to a computer or a smart phone for syncing and uploading wearable activity
data.

- Be able to speak and read English.

Exclusion Criteria:

- Any condition that causes severe pain with exertion.

- History of bone fractures.

- 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.

- Acute or chronic respiratory disease that is severe enough to compromise the ability
of the participant to safely engage in exercise training protocol.

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

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

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