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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.

Authors
  • 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.
Type
Published Article
Journal
British Journal of Urology
Publisher
Wiley (Blackwell Publishing)
Publication Date
Apr 01, 2018
Volume
121
Issue
4
Pages
534–539
Identifiers
DOI: 10.1111/bju.13890
PMID: 28437029
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

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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