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

Fred Hutchinson Cancer Center (FHCC)

Status: Terminated

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02454517

9369

RG1001233 (Other Identifier)

R01CA184075 (U.S. NIH Grant/Contract)

NCI-2015-00686 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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117 participants in 2 patient groups

Arm I (diet and exercise lifestyle intervention)

Experimental group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Behavioral: Behavioral Dietary Intervention

Behavioral: Exercise Intervention

Other: Laboratory Biomarker Analysis

Arm II (control)

Active Comparator group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Other: Laboratory Biomarker Analysis

Other: Informational Intervention