Clinical trial NCT02454517: Diet and Exercise Program to Promote Weight Loss and Improve Health in Men With Low- or Low-Intermediate-Risk Prostate Cancer
Official title: PALS: Prostate Cancer Active Lifestyle Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Adenocarcinoma
Stage I Prostate Cancer AJCC V7
Stage IIA Prostate Cancer AJCC v7
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-05-27
Enrollment: 117
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Fasting Glucose at 6 Months
timeFrame: Baseline to 6 months
measure: Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months
timeFrame: Baseline to 6 months
measure: Change in Expression of Insulin Receptor (IR), IGF-1R, and Protein Kinase B (AKT) on Prostate Cancer Epithelial Cells
timeFrame: Baseline (6 months prior to randomization) to follow-up surveillance biopsy (6 months post-randomization)
measure: Weight at 12 Months
timeFrame: 12 months (6 months after active intervention)
measure: Change From Baseline in Fasting Insulin at 6 Months
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Health Related Quality of Life (HRQOL) at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jonathan Wright
role: PRINCIPAL_INVESTIGATOR
References: