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

BJU Int. 2018 Apr;121(4):534-539. doi: 10.1111/bju.13890. Epub 2017 May 21.

Abstract

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 III clinical trial testing the efficacy of a high-vegetable diet to prevent progression in patients with prostate cancer on active surveillance (AS). Participants were randomized to a validated diet counselling intervention or to a control condition. Chi-squared and Kruskal-Wallis analyses were used to assess between-group differences at baseline.

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

Conclusion: The MEAL study shows the feasibility of implementing national, multi-institutional phase III clinical trials of diet for prostate cancer and of testing interventions to prevent disease progression in AS.

Keywords: #PCSM; #ProstateCancer; active surveillance; carotenoids; diet; outcomes; prevention.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Biopsy
  • Diet / methods*
  • Diet / statistics & numerical data*
  • Disease Progression
  • Humans
  • Male
  • Middle Aged
  • Prostate-Specific Antigen / blood
  • Prostatic Neoplasms / diet therapy*
  • Prostatic Neoplasms / epidemiology
  • Prostatic Neoplasms / pathology
  • Prostatic Neoplasms / prevention & control*
  • Vegetables

Substances

  • Prostate-Specific Antigen