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

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ClinicalTrials.gov Identifier: NCT02454517
Recruitment Status : Recruiting
First Posted : May 27, 2015
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Prostate Adenocarcinoma Stage I Prostate Cancer AJCC V7 Stage IIA Prostate Cancer AJCC v7 Behavioral: Behavioral Dietary Intervention Behavioral: Exercise Intervention Other: Informational Intervention Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: PALS: Prostate Cancer Active Lifestyle Study
Actual Study Start Date : May 19, 2016
Estimated Primary Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (diet and exercise lifestyle intervention)
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.
Behavioral: Behavioral Dietary Intervention
Undergo DPP lifestyle intervention

Behavioral: Exercise Intervention
Undergo DPP lifestyle intervention

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Arm II (control)
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.
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 Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Change in expression of insulin receptor (IR), IGF-1R, and protein kinase B (AKT) on prostate cancer epithelial cells [ Time Frame: Baseline (6 months prior to randomization) to follow-up surveillance biopsy (6 months post-randomization) ]
    Global assessment of intervention effects will be evaluated using a two-sided t-test (or Wilcoxon rank sum test). Linear regression will be used to assess associations of IR, IGF-1R, and AKT expression with systemic measures of glycemic control at 6 months. Exploratory analyses will also evaluate associations between adverse pathology, biomarkers of glycemic control and IR/IGF-1R/AKT expression.

  2. Change in fasting C-peptide, insulin, IGF-1, IGF-BP3, and adiponectin levels relative to baseline between the intervention and control arms [ Time Frame: Baseline to up to 12 months ]
    Global and subgroup effects based on intention-to-treat analyses will be compared.

  3. Change in fasting glucose levels relative to baseline between the intervention and control arms [ Time Frame: Baseline to up to 12 months ]
    Global assessment of intervention effects will be evaluated using a two-sided t-test or Wilcoxon rank sum test if normality of the measurement is questionable (as determined by QQ-normal plots). Further analysis will quantify effects of patient age, body mass index (BMI) and other body composition measures on change in fasting glucose using linear regression. Differential effects between intervention and control arms will be quantified using interaction terms. All analyses will compare effects based on intention-to-treat.

  4. Sustainability of beneficial changes in weight and glucose regulation [ Time Frame: 6 months after active intervention ]
    The Diabetes Prevention Program (DPP) research group will be followed for characterization of sustained weight loss as maintenance of a 7% reduction in weight and sustained glucose regulation as maintenance within 5% of 6-month levels. The subset of participants who did and did not achieve this goal both separately and combined will be evaluated. A one-sample test of proportions will be used to determine whether the proportion of participants that are able to sustain lifestyle changes differs from zero.


Secondary Outcome Measures :
  1. Change in health related quality of life (HRQOL), namely urinary and sexual quality of life (QOL) and bother [ Time Frame: Baseline to up to 12 months ]
    Intervention effects will be evaluated using a two-sided t-test, and models will be adjusted for age, socioeconomic status (SES), marital status, and baseline BMI. The minimally important difference for the HRQOL instruments will be a mean difference of at least 5 points.

  2. Proportion of participants with adverse pathology (Gleason upgrading, increase in number of positive cores, cores > 50% positive) on follow-up surveillance biopsy [ Time Frame: Up to 6 months ]
    A two-sample test of proportions will be used to determine the difference between the intervention and control arms.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454517


Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Jonathan L. Wright    206-667-7987    jlwright@u.washington.edu   
Principal Investigator: Jonathan L. Wright         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jonathan Wright Fred Hutch/University of Washington Cancer Consortium

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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT02454517     History of Changes
Other Study ID Numbers: 9369
NCI-2015-00686 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9369 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
R01CA184075 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Overweight
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Body Weight
Signs and Symptoms