Diet in Altering Disease Progression in Patients With Prostate Cancer 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.
|Prostate Cancer||Other: dietary education and counseling Other: prostate cancer foundation booklet|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance|
- disease progression [ Time Frame: Up to 2 years ]
- time to progression [ Time Frame: Up to 2 years ]
- time to treatment [ Time Frame: Up to 2 years ]
- quality of life [ Time Frame: Up to 2 years ]
- dietary recall evaluated at baseline, month 12 and month 24 [ Time Frame: Up to 2 years ]
|Study Start Date:||January 2011|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Experimental: Arm A - MEAL Program Intervention
Patients will receive dietary education and telephone counseling sessions over 24 months.
|Other: dietary education and counseling|
Experimental: Arm B - Prostate Cancer Foundation Booklet
Patients receive information about diet, nutrition, exercise and cancer. Patients also receive regularly scheduled newsletters.
|Other: prostate cancer foundation booklet|
CALGB 70807 is a randomized, phase III clinical trial designed to test this practical, diet-based intervention for prostate cancer in a broader clinical setting. Patients on AS will be randomized either to an intervention of centralized, telephone-based dietary counseling and structured dietary education or to a comparison control condition in which they receive the Prostate Cancer Foundation booklet. Study endpoints will include disease progression, incidence of treatment, and health-related quality of life.
- To determine if a telephone-based dietary intervention compared to no intervention will decrease clinical progression in AS patients.
- 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 (black or african american vs other), and baseline prostate biopsy (0-12 months before registration vs > 12-24 months before registration). Patients are randomized to 1 of 2 treatment arms. Please see the arms section for more information.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238172
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|Study Chair:||J. Kellogg Parsons, MD, MHS||University of California, San Diego|