Intensive Diet and Exercise or Standard of Care in Improving Physical Function and Quality of Life in Patients With Prostate Cancer Undergoing Androgen Deprivation Therapy

PRIMARY OBJECTIVES:

I. To compare the effects of the intensive lifestyle intervention and standard of care
treatments on functional limitations (FL), body composition (BC), and quality of life (QOL)
in prostate cancer (PC) patients on androgen deprivation therapy (ADT).

II. To determine the feasibility of delivering an intensive lifestyle exercise and dietary
intervention to PC patients undergoing ADT.

III. To identify the intermediate variables that account for the beneficial effect of the
lifestyle intervention on functional limitations and QOL.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I:

EXERCISE COMPONENT: Patients undergo 1 hour of intensive exercise comprising 30 minutes of
aerobic exercise and 30 minutes of resistance exercise twice weekly during weeks 1-6, once
weekly during weeks 7-8, and independently during weeks 7-12.

BEHAVIORAL ACTIVITY COUNSELING: Patients undergo behavioral activity counseling in small
group sessions over 20 minutes once weekly during months 1-2 and individualized activity
counseling via telephone calls over 20 minutes every 2 weeks for 3 months.

DIETARY COMPONENT: Patients undergo nutritional counseling over 30 minutes once weekly
during months 1-2 and then every 2 weeks via telephone calls during month 3.

ARM II: Patients receive standard care and educational literature describing the American
Institute of Cancer Research dietary and physical activity guidelines. Patients also receive
phone calls over 20 minutes every 2 weeks for 3 months focusing on routine prostate cancer
self-management. After 3 months, patients undergo 2 supervised exercise training and dietary
counseling sessions.

Inclusion Criteria:

- Diagnosed with PC: histologically-defined diagnosis of PC based upon providing
pathology reports and staging studies

- Initiating ADT: will be initiating a planned course of at least 3 months of ADT; the
ADT is defined as: (a) surgical castration; (b) gonadotropin-releasing hormone (GNRH)
antagonist alone; (c) GNRH antagonist with oral androgen receptor blockade, and (d)
GNRH antagonist, oral androgen receptor blockade, and 5-alpha reductase inhibitors;
we will not include men with only oral antiandrogen therapy such as 5-alpha reductase
inhibitors alone or oral antiandrogens alone, as they do not produce castrate levels
of testosterone

- Stage: at enrollment, all men have stage IV disease, which is our major presentation
to the medical oncology prostate program; two groups are typical; the first involves
men who usually present for initial diagnosis with minimally metastatic disease and
elevated prostate-specific antigen (PSA) and staging studies with modest nodal
enlargement or bone lesions, typically asymptotic; the second group involves men we
have been monitoring after local therapy, surgery or radiation, but who have a slow
rise in PSA indicating failure of curative therapy; at some point in time
asymptomatic metastases are noted on scans, and ADT is offered

- Sedentary lifestyle: fewer than 60 minutes of participation in structured moderate
intensity physical activity each week

- Health status: all participants must be free of active cardiovascular disease (CVD),
unstable angina, arrhythmia, or severe systemic disease that would make moderate
intensity exercise participation unsafe; men with prior CVD that have had successful
intervention/treatment that are no longer have active CVD and are medically cleared
to safely exercise by their physician will be eligible to participate in the study

- Consents: willing to give an informed consent and sign a Health Insurance Portability
and Accountability Act (HIPPA) authorization form

- Physician medical clearance: all men will have medical clearance to participate in
the study from a board certified internist, primary care physician, or cardiologist
(for men with ongoing cardiovascular disease) prior to inclusion in the study; all
participants' treating oncologists will also provide consent for participation prior
to inclusion in the study