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

Prostate Adenocarcinoma Clinical Trial

— PALS  

Official title:

PALS: Prostate Cancer Active Lifestyle Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02454517
• Other study ID #: 9369
• Secondary ID: NCI-2015-00686RG
• Status: Terminated
• Phase: N/A
• Start date: May 19, 2016
• Est. completion date: September 30, 2021

Study information

• Verified date: December 2022
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 117
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Behavioral Dietary Intervention
Undergo DPP lifestyle intervention
• Exercise Intervention
Undergo DPP lifestyle intervention

Other:
• Informational Intervention
Receive oral and written guidelines and meet with dietician
• Laboratory Biomarker Analysis
Correlative studies
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Fasting Glucose at 6 Months	Mean and standard deviation of change from baseline.	Baseline to 6 months
Primary	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
Primary	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)
Primary	Weight at 12 Months	Mean and standard deviation of weight at 12 months	12 months (6 months after active intervention)
Primary	Change From Baseline in Fasting Insulin at 6 Months	Mean and standard deviation of change from baseline.	Baseline to 6 months
Secondary	Health Related Quality of Life (HRQOL) at 6 Months	Mean and standard deviation of Quality of Life measures at 6 months.	6 months