Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01238172
First received: November 9, 2010
Last updated: November 12, 2013
Last verified: November 2013

November 9, 2010
November 12, 2013
January 2011
June 2017   (final data collection date for primary outcome measure)
Progression defined by PSA doubling time (PSADT) < 3 years, PSA > 10 at any time, or Gleason sum on repeat biopsy ≥ 7 (for men < 70 years) or ≥ 4+3 = 7 (for men ≥ 70 year) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Progression defined by PSA doubling time (PSADT) < 3 years, PSA > 10 at any time, or Gleason sum on repeat biopsy ≥ 7 (for men < 70 years) or ≥ 4+3 = 7 (for men ≥ 70 year) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01238172 on ClinicalTrials.gov Archive Site
  • Progression defined by PSADT and time to progression [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Time to treatment [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Comparison of quality of life (anxiety and depression, prostate cancer symptom checklist) between the two arms [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Diet as evaluated by three separate 24-hour dietary recalls at baseline and at 12 and 24 months [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Progression defined by PSADT and time to progression [ Designated as safety issue: No ]
  • Time to treatment [ Designated as safety issue: No ]
  • Comparison of quality of life (anxiety and depression, prostate cancer symptom checklist) between the two arms [ Designated as safety issue: No ]
  • Diet as evaluated by three separate 24-hour dietary recalls at baseline and at 12 and 24 months [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance
The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance

RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer.

PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.

OBJECTIVES:

Primary

  • To determine if a telephone-based dietary intervention compared to no intervention will decrease clinical progression in AS patients.

Secondary

  • To compare the incidence of active treatment (surgery, irradiation, local ablation, or androgen deprivation) in AS patients receiving dietary intervention compared to no intervention.
  • To compare prostate cancer-related anxiety in AS patients receiving dietary intervention compared to no intervention.
  • To compare health-related quality of life in AS patients receiving dietary intervention compared to no intervention.

OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 70 years vs > 70 years), race (African American vs other), and time of baseline prostate biopsy (0-12 months before registration vs > 12-24 months before registration). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive the MEAL program intervention with dietary education and telephone counseling sessions for 24 months. Patients receive the "Participant Notebook", which provides written material describing the counseling program. It also outlines the dietary targets, offers supporting information on strategies to achieve these targets, supplies referent tools to help patients accurately estimate servings of target foods, and offers recipes and articles about diet and prostate cancer. The counseling sessions are divided into 4 phases, with the first three phases completed in 7 months and the fourth phase continuing for 17 months. The first phase comprises 6 counseling calls focusing on education and the rapid development of self-efficacy, the second phase comprises 4 calls over a 2-month period focusing on practical and consistent implementation of the dietary pattern, the third phase comprises 4 calls over a 4-month period helping patients habituate to the dietary pattern by providing regular performance reviews, and the fourth phase comprises 8 calls over a 17-month period and is a maintenance phase. Patients are encouraged to achieve 7 servings per day of vegetables (2 cruciferous, 2 tomato products, 3 other vegetables), 2 servings per day of whole grains, 1 serving per day of beans or other legumes, and 2 servings per day of fruit. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters focus on study goals and progress and provide tips on achieving and maintaining diet change. They also include information on diet and cancer, the challenges of diet change, the advances in prostate cancer control, and new recipes.
  • Arm II: Patients receive standard United States Department of Agriculture dietary guidelines for Americans. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters contain general information about diet and healthy lifestyle.

Blood (plasma and serum) and tissue samples are collected at baseline and at 12 and 24 months for biomarker and pharmacogenomic studies.

Patients complete quality-of-life assessments (Personal Habits Questionnaire, Functional Assessment of Cancer Therapy Scale-Prostate (FACT-P), Memorial Anxiety Scare for Prostate Cancer (Max-PC), International Prostate Symptom Score (IPSS), Expanded Prostate Cancer Index Composite 26 (EPIC-26), and Nutrition Self-Efficacy and Satisfaction with the MEAL Program) at baseline and at 6, 12, 18, and 24 months.

After study entry, patients are followed up every 3 months for 2 years.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Behavioral: telephone-based intervention
    Patients undergo telephone counseling
  • Other: counseling intervention
    Patients undergo telephone counseling
  • Other: educational intervention
    Patients receive detailed or general newsletters
  • Procedure: therapeutic dietary intervention
    Patients receive dietary education
  • Experimental: Arm I
    Patients receive the MEAL program intervention with dietary education and telephone counseling sessions of 24 months; the "Participant Notebook", which provides written material describing the counseling program, dietary targets, offers supporting information on strategies to achieve these targets, supplies referent tools to help patients accurately estimate servings of target foods, and recipes and articles about diet and prostate cancer. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters focus on study goals and progress and provide tips on achieving and maintaining diet change and include information on diet and cancer, the challenges of diet change, the advances in prostate cancer control, and new recipes.
    Interventions:
    • Behavioral: telephone-based intervention
    • Other: counseling intervention
    • Other: educational intervention
    • Procedure: therapeutic dietary intervention
  • Active Comparator: Arm II
    Patients receive standard United States Department of Agriculture dietary guidelines for Americans. Patients also receive 8 regularly scheduled newsletters over the course of 24 months. The newsletters contain general information about diet and healthy lifestyle.
    Intervention: Other: educational intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
464
Not Provided
June 2017   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Biopsy-proven (consisting of ≥ 10 tissue cores) adenocarcinoma of the prostate diagnosed within 24 months prior to presentation

    • < 25% of biopsy tissue cores positive for cancer
    • ≤ 50% of any one biopsy tissue core positive for cancer
  • Clinical stage ≤ T2a
  • Patients who have prostate cancer with distant metastases are not eligible
  • For men ≤ 70 years, biopsy Gleason score ≤ 6; for men > 70 years, biopsy Gleason score ≤ (3 + 4) = 7
  • Serum PSA < 10 ng/mL

    • Baseline PSA for determination of eligibility must be measured after discontinuation of any 5-alpha reductase inhibitors
  • Patients are offered registration to the correlative study CALGB-151105

PATIENT CHARACTERISTICS:

  • Life expectancy of at least 3 years
  • Patients must be able to read and comprehend English language text and be able to understand spoken English over the phone
  • Patients who have had a history of non-cutaneous malignancy (other than nonmelanoma skin cancer) in the previous 5 years are not eligible
  • Successful completion of three 24-hour dietary recalls during the run-in period

PRIOR CONCURRENT THERAPY:

  • Patients who have had prior treatment for prostate cancer by surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen-deprivation therapy are not eligible
  • Patients who are currently taking vitamin supplements including lycopene and beta-carotene are eligible
  • Patients who are currently taking coumadin are not eligible
  • Patients consuming ≥ 6 servings per day of fruits and vegetables (not including juices), as measured by the run-in dietary recalls, are not eligible
  • Patients receiving treatment with 5-alpha reductase inhibitors within 90 days prior to preregistration are not eligible
Male
50 Years to 80 Years
No
United States
 
NCT01238172
CDR0000687958, CALGB-70807
Yes
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: J. Kellogg Parsons, MD, MHS University of California, San Diego
Study Chair: James Marshall, PhD Roswell Park Cancer Institute
Alliance for Clinical Trials in Oncology
November 2013

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