Diet and Exercise Program to Promote Weight Loss and Improve Health in Men With Low- or Low-Intermediate-Risk Prostate Cancer (PALS)
Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC V7, Stage IIA Prostate Cancer AJCC v7
About this trial
This is an interventional supportive care trial for Prostate Adenocarcinoma
Eligibility Criteria
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
Sites / Locations
- Fred Hutch/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I (diet and exercise lifestyle intervention)
Arm II (control)
The goals of the diet and exercise lifestyle intervention is for patients to lose 7% total body weight. 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.
Patients receive an informational intervention along with a 20-30 minute individual session with a dietitian and a goal of 30 minutes of physical activity 5 days a week.