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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 : July 31, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Tracking Information
First Submitted Date  ICMJE May 22, 2015
First Posted Date  ICMJE May 27, 2015
Last Update Posted Date July 31, 2020
Actual Study Start Date  ICMJE May 19, 2016
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2015)
  • 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.
  • 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.
  • 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, 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.
  • Sustainability of beneficial changes in weight and glucose regulation [ Time Frame: 6 months after active intervention ]
    The 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2015)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diet and Exercise Program to Promote Weight Loss and Improve Health in Men With Low- or Low-Intermediate-Risk Prostate Cancer
Official Title  ICMJE PALS: Prostate Cancer Active Lifestyle Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Prostate Adenocarcinoma
  • Stage I Prostate Cancer AJCC V7
  • Stage IIA Prostate Cancer AJCC v7
Intervention  ICMJE
  • 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 Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Behavioral Dietary Intervention
    • Behavioral: Exercise Intervention
    • Other: Laboratory Biomarker Analysis
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • 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.
    Interventions:
    • Other: Informational Intervention
    • Other: Laboratory Biomarker Analysis
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2015)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02454517
Other Study ID Numbers  ICMJE 9369
NCI-2015-00686 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RG1001233 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
R01CA184075 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fred Hutchinson Cancer Research Center
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jonathan Wright Fred Hutch/University of Washington Cancer Consortium
PRS Account Fred Hutchinson Cancer Research Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP