The Men’s Eating and Living (MEAL) Study (CALGB 70807 [Alliance]): Recruitment Feasibility and Baseline Demographics of a Randomized Trial of Diet in Men on Active Surveillance for Prostate Cancer.

OBJECTIVE
To assess the feasibility of performing national, randomized trials of dietary interventions for localized prostate cancer.

METHODS
The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) is a phase 3 clinical trial testing the efficacy of a high-vegetable diet to prevent progression in prostate cancer patients on active surveillance. Participants were randomized to a validated diet counseling intervention or a control condition. Chi-Square and Kruskal Wallis analyses were used to assess between-group differences at baseline.

RESULTS
From 2011 to 2015, 478 (103%) of a targeted 464 patients were randomized at 91 study sites. At baseline, mean (SD) age was 64 (6) years and PSA 4.9 (2.1) ng/mL. Fifty-six (12%) participants were African-American, 17 (4%) Hispanic/Latino, and 16 (3%) Asian-American. There were no significant between-group differences for age (p-value = 0.98), race/ethnicity (p-value = 0.52), geographic region (p-value = 0.60), time since prostate cancer diagnosis (p-value = 0.85), PSA (p-value = 0.96), clinical stage (T1c or T2a, p-value = 0.27), or Gleason sum (Gleason 6 or 3+4 = 7, p-value = 0.76). In a pre-planned analysis, the baseline prostate biopsy samples of the first 50 patients underwent central pathology review to confirm eligibility, with an expectation that <10% would become ineligible. One (2%) of 50 patients became ineligible.

CONCLUSION
The MEAL Study demonstrates the feasibility of implementing national, multi-institutional phase 3 clinical trials of diet for prostate cancer and of testing interventions to prevent disease progression in active surveillance. This article is protected by copyright. All rights reserved.