The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients 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.
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.
OBJECTIVES:
Primary
Secondary
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.
Preregistration Eligibility:
Histologic Documentation:
The initial biopsy showing diagnosis of prostate cancer should be used for the purposes of determining eligibility.
However, if a subsequent biopsy performed before patient enrollment shows that the patient is ineligible, he may not be enrolled to the study.
Eligible patients must meet all of the following criteria:
NOTE: If a patient undergoes a transurethral resection of the prostate (TURP) for benign prostatic hyperplasia (BPH), and prostate cancer is diagnosed incidentally from the TURP specimen, eligibility for CALGB 70807 cannot be determined from the TURP specimen. However, if the patient subsequently undergoes a minimum 10-core prostate biopsy within 2 years of prostate cancer diagnosis from the TURP, and prostate cancer is detected in the biopsy specimen and meets the requirements above, the patient is eligible for this study. If prostate cancer is not detected in the biopsy specimen, the patient is not eligible.
Prior Treatment: 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 have had a history of non-cutaneous malignancy (other than nonmelanoma skin cancer) in the previous 5 years are not eligible.
Language: Patients must be able to read and comprehend English language text and be able to understand spoken English over the phone.
Life expectancy of at least 3 years
Patients who are currently taking vitamin supplements including lycopene and beta-carotene are eligible.
Patients receiving treatment with 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) within 90 days prior to preregistration are not eligible. Treatment with these agents during the protocol intervention is not permitted.
Patients who are currently taking coumadin are not eligible.
Participants will be men aged 50 to 80 years.
For men ≤ 70 years, biopsy Gleason score ≤ 6; for men > 70 years, biopsy Gleason score ≤ (3 + 4) = 7.
Required Initial Laboratory Values:
Registration Eligibility:
Fairbanks, Alaska 99701, United States
Loma Linda, California 92354, United States
Los Angeles, California 90048, United States
San Diego, California 92120, United States
Aurora, Colorado 80045, United States
Hartford, Connecticut 06105, United States
Lakeland, Florida 33805, United States
Orlando, Florida 32803-1273, United States
Boise, Idaho 83706, United States
La Porte, Indiana 46350, United States
Kansas City, Kansas 66160-7357, United States
Lexington, Kentucky 40536-0093, United States
Scarborough, Maine 04074, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
St Louis, Missouri 63110, United States
Billings, Montana 59102, United States
Missoula, Montana 59807, United States
Englewood, New Jersey 07631, United States
Voorhees Township, New Jersey 08043, United States
Lake Success, New York 11042, United States
Manhasset, New York 11030, United States
Rochester, New York 14642, United States
Chapel Hill, North Carolina 27599-7295, United States
Allentown, Pennsylvania 18105, United States
San Antonio, Texas 78229-3900, United States