Diet and Exercise Program to Promote Weight Loss and Improve Health in Men With Low- or Low-Intermediate-Risk Prostate Cancer

PRIMARY OBJECTIVES:

I. To test whether the Diabetes Prevention Program (DPP) lifestyle intervention (versus [vs.]
control) improves serum fasting glucose.

II. To test whether the DPP lifestyle intervention (vs. control) improves serum biomarkers of
glucose regulation (insulin, C-peptide, insulin-like growth factor-1 [IGF-1], IGF binding
protein 3 [IGF-BP3] and adiponectin).

III. To test whether the DPP lifestyle intervention decreases the levels of insulin receptor
or insulin-like growth factor-1 receptor (IGF-1R) in prostate cancer (PCa) tissue epithelium
on follow-up prostate biopsy.

IV. To test whether PCa patients randomized to the DPP lifestyle intervention sustain the
lifestyle changes for at least 6 months after the end of the intervention period.

SECONDARY OBJECTIVES:

I. To evaluate whether the DPP lifestyle intervention improves health-related quality of
life.

II. To evaluate whether the DPP lifestyle intervention effects on pathologic features of
follow-up prostate biopsies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients meet with a nutritionist 11 times during the first 6 months to receive the
structured diet and exercise instruction. Participants complete exercise sessions supervised
by an exercise specialist, and will wear a heart rate monitor periodically during the study.

ARM II: Patients receive oral and written information based on general U.S. dietary and
physical activity guidelines along with a 20-30 minute individual session with a dietitian
and a goal of 30 minutes of physical activity 5 days a week.

After completion of study, patients are followed up at 3, 6, and 12 months.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate, clinically localized, low or
low-intermediate risk disease (T1C/T2a, Gleason =< 7 [3+4], prostate-specific antigen
[PSA] < 20)

- Primary treatment is active surveillance (AS) with planned annual surveillance
biopsies

- Body mass index (BMI) >= 25 kg/m^2; and

- Physically able to undertake a diet and exercise program

Exclusion Criteria:

- Current, recent (< 1 year), or planning to join a weight loss program or take appetite
suppressants

- Steroid hormone use (antiandrogen therapy [ADT]) within the past 12 months

- Significant cardiovascular disease precluding an exercise program, including recent
(within 6 months) myocardial infarction or stroke, pulmonary edema, myocarditis,
pericarditis, unstable angina, pulmonary embolism/deep venous thrombosis (PE/DVT),
uncontrolled hypertension (systolic blood pressure [SBP] > 200; diastolic blood
pressure [DBP] > 110), uncontrolled arrhythmia, heart failure; or

- Insulin dependent diabetes mellitus (DM) and/or metformin use

- Doctor of medicine (MD) confirmed cognitive impairment

- Current alcohol or narcotic abuse