NCT02454517

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

PALS: Prostate Cancer Active Lifestyle Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Adenocarcinoma
• Stage I Prostate Cancer AJCC V7
• Stage IIA Prostate Cancer AJCC v7

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Dietary Intervention	Undergo DPP lifestyle intervention
BEHAVIORAL	Exercise Intervention	Undergo DPP lifestyle intervention
OTHER	Informational Intervention	Receive oral and written guidelines and meet with dietician
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2016-05-19
• Primary completion: 2021-09-30
• Completion: 2021-09-30
• First posted: 2015-05-27
• Last updated: 2023-01-04
• Results posted: 2022-12-16

Locations

1 site across 1 country: United States