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

Not Applicable

Terminated

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

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

Registration Number: NCT02454517

Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 117

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (diet and exercise lifestyle intervention)	Exercise Intervention	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.
Arm I (diet and exercise lifestyle intervention)	Behavioral Dietary Intervention	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.
Arm II (control)	Questionnaire Administration	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.
Arm I (diet and exercise lifestyle intervention)	Laboratory Biomarker Analysis	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.
Arm I (diet and exercise lifestyle intervention)	Quality-of-Life Assessment	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.
Arm I (diet and exercise lifestyle intervention)	Questionnaire Administration	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.
Arm II (control)	Informational Intervention	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.
Arm II (control)	Laboratory Biomarker Analysis	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.
Arm II (control)	Quality-of-Life Assessment	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.

Primary Outcome Measures

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