Study Stopped
Terminated due to insufficient funding
Diet and Exercise Program to Promote Weight Loss and Improve Health in Men With Low- or Low-Intermediate-Risk Prostate Cancer
PALS
PALS: Prostate Cancer Active Lifestyle Study
4 other identifiers
interventional
117
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedStudy Start
First participant enrolled
May 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedResults Posted
Study results publicly available
December 16, 2022
CompletedJanuary 4, 2023
December 1, 2022
5.4 years
May 22, 2015
September 28, 2022
December 28, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (1)
Health Related Quality of Life (HRQOL) at 6 Months
6 months
Study Arms (2)
Arm I (diet and exercise lifestyle intervention)
EXPERIMENTALThe 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)
ACTIVE COMPARATORPatients 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.
Interventions
Undergo DPP lifestyle intervention
Undergo DPP lifestyle intervention
Receive oral and written guidelines and meet with dietician
Correlative studies
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fred Hutchinson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeannette M. Schenk, PhD
- Organization
- Fred Hutchinson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Wright
Fred Hutch/University of Washington Cancer Consortium
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 22, 2015
First Posted
May 27, 2015
Study Start
May 19, 2016
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
January 4, 2023
Results First Posted
December 16, 2022
Record last verified: 2022-12