The MEAL study — an update


Back in 2011, what is now the Alliance for Clinical Trials in Oncology (ACTO) but was then CALGB (Cancer and Leukemia Group B) initiated the Men’s Eating and Living (MEAL) study. This trial is, we hope, going to give us some real answers to a very important question: does diet affect risk for the progression of prostate cancer in men on active surveillance?

The details of the MEAL study can be found on the ClinicalTrials.gov web site. Here’s the quick summary:

  • The trial has enrolled some 464 patients with prostate cancer, all being initially managed on active surveillance at study entry.
  • All patients had to have had a diagnosis of adenocarcinoma of the prostate and meet the following additional criteria,
    • A clinical stage of ≤ T2a
    • < 25 percent of all biopsy tissue positive for prostate cancer
    • ≤ 50 percent of any one biopsy tissue core positive for cancer
    • A serum PSA level of < 10 ng/ml
    • A Gleason score of ≤ 3 + 3 = 6 for men of ≤ 70 years
    • A Gleason score of ≤ 3 + 4 = 7 for men of > 70 years
    • Age between 50 and 80 years
  • This is a multi-center study, with patients being enrolled at 180 different study sites (all in the US).
  • The trial participants were enrolled to one or other of two trial arms:
    • Arm A: Initial dietary education with ongoing telephone counseling over 24 months designed to increase the probability of a diet high in vegetables and other healthy foodstuffs and relatively low in red meat, carbohydrates, and dairy products
    • Arm B: Standard care with no dietary counseling beyond a booklet issued by the Prostate Cancer Foundation and regular newsletters with information about diet, nutrition, exercise, and cancer
  • The primary study endpoint is disease progression at up to 2 years after study entry.

We bring this up now because the trial was originally expected to have all data available for study analysis some time in September this year, so maybe we will be able to get the results of this important trial at one of the following meetings next year: the Genitourinary Cancers Symposium in San Francisco (in February); the annual meeting of the American Urology Association, also in San Francisco (in May); or the annual meeting of the American Society for Clinical Oncology, in Chicago (in June).

Update to the initial post above (as of October 27, 2017): We have been advised by the principal investigator for the MEAL study that: (a) yes, all study data have now been collected and are currently being analyzed, and (b) yes, it is hoped that it will be possible to present the results of the study at the AUA meeting in San Francisco in May (but this is not confirmed at the present time).

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