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

Study Overview
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Brief Summary
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This randomized phase III trial studies a diet and exercise program based on the Diabetes Prevention Program to promote weight loss and improve health in men with low-risk or low-intermediate-risk prostate cancer on active surveillance. A lifestyle intervention that promotes weight loss may influence prostate health. A combined diet and exercise program that is based on the Diabetes Prevention Program may affect markers (or biomarkers) of prostate cancer progression. Gathering this information may help doctors understand how obesity affects prostate cancer progression and may help lead to a program that can reduce the risk of prostate cancer progression.

Detailed Description
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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.

Official Title
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PALS: Prostate Cancer Active Lifestyle Study

Conditions
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Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC V7, Stage IIA Prostate Cancer AJCC v7

Intervention / Treatment
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* Behavioral: Behavioral Dietary Intervention
* Behavioral: Exercise Intervention
* Other: Informational Intervention
* Other: Laboratory Biomarker Analysis
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (diet and exercise lifestyle intervention)<br>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. | Behavioral: Behavioral Dietary Intervention<br>* Undergo DPP lifestyle intervention<br>Behavioral: Exercise Intervention<br>* Undergo DPP lifestyle intervention<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (control)<br>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. | Other: Informational Intervention<br>* Receive oral and written guidelines and meet with dietician<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fasting Glucose at 6 Months | Mean and standard deviation of change from baseline. | Baseline to 6 months | 
| Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months | Mean and standard deviation of change from baseline. | Baseline to 6 months | 
| Change in Expression of Insulin Receptor (IR), IGF-1R, and Protein Kinase B (AKT) on Prostate Cancer Epithelial Cells | Mean and standard deviation of change from baseline. | Baseline (6 months prior to randomization) to follow-up surveillance biopsy (6 months post-randomization) | 
| Weight at 12 Months | Mean and standard deviation of weight at 12 months | 12 months (6 months after active intervention) | 
| Change From Baseline in Fasting Insulin at 6 Months | Mean and standard deviation of change from baseline. | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life (HRQOL) at 6 Months | Mean and standard deviation of Quality of Life measures at 6 months. | 6 months |