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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.

  • Parsons, J Kellogg1, 2, 3
  • Pierce, John P4
  • Mohler, James5
  • Paskett, Electra6
  • Jung, Sin-Ho7
  • Morris, Michael J8
  • Small, Eric9
  • Hahn, Olwen10
  • Humphrey, Peter11
  • Taylor, John12
  • Marshall, James12
  • 1 Division of Urologic Oncology, UC San Diego Moores Comprehensive Cancer Center, La Jolla, CA, USA.
  • 2 Department of Urology, UC San Diego Health System, La Jolla, CA, USA.
  • 3 VA San Diego Healthcare System, La Jolla, CA, USA.
  • 4 Department of Family Medicine and Public Health and Moores Cancer Center, University of California, San Diego, La Jolla, CA, USA.
  • 5 Department of Urology, Roswell Park Cancer Institute, Buffalo, NY, USA.
  • 6 Department of Medicine, College of Medicine, Comprehensive Cancer Center, Ohio State University, Columbus, OH, USA.
  • 7 Alliance Statistics and Data Center, Duke University, Durham, NC, USA.
  • 8 Memorial Sloan Kettering Cancer Center, New York, NY, USA.
  • 9 UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.
  • 10 Alliance Central Protocol Operations, University of Chicago, Chicago, IL, USA.
  • 11 Department of Pathology, Yale University Medical School, New Haven, CT, USA.
  • 12 Department of Prevention and Population Sciences, Roswell Park Cancer Institute, Buffalo, NY, USA.
Published Article
British Journal of Urology
Wiley (Blackwell Publishing)
Publication Date
Apr 01, 2018
DOI: 10.1111/bju.13890
PMID: 28437029


To assess the feasibility of performing national, randomized trials of dietary interventions for localized prostate cancer. 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. 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. 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. © 2017 The Authors BJU International © 2017 BJU International Published by John Wiley & Sons Ltd.

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