Trial Information

The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients 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.