Diet, veggies, MEAL, and prostate cancer progression
Posted Mar 18 2011 12:00am
The issue of whether changes in diet and the use of supplements affect risk for and progression of prostate cancer is regular fodder for media coverage. One of the major problems is that there has never been a large, well-controlled clinical trial that could provide definitive (“level 1″) evidence in support of the clinical benefit of any specific diet.
The Men’s Eating and Living (MEAL) trial has been initiated by the Cancer and Leukemia Group B clinical trials consortium in an attempt to gain evidence about the effects of a high-vegetable diet on the progression of prostate cancer. This will be the first-ever, large, randomized controlled, Phase III clinical trial to investigate the impact of a specific diet on progression of prostate cancer.
The full details about this trial can be found on the ClinicalTrials.gov web site, and the trial is expected to start enrolling patients in the relatively near future. However, it is not yet clear how or where patients can enroll in this study; no doubt this information will be available shortly. The lead investigators for this study are at the Moores Cancer Center at the University of California Dan Diego and at Roswell Park Cancer Center in Buffalo, New York, so it’s a pretty safe bet that investigators at those two sites will be interested in recruiting patients.
The basic information is as follows:
MEAL is a randomized, controlled clinical trial.
To be eligible, men must be between 50 and 80 years of age and have biopsy-proven prostate cancer.
They must have relatively low-risk disease.
They must be on either active surveillance or watchful waiting and have had no meaningful local therapy or androgen deprivation therapy.
The enrollees will be randomized to one of two “management” groups:
The men in Group A will receive intensive dietary intervention over a period of 24 months (including diet recommendations, newsletters, telephone counseling, etc.), all designed to encourage a high-vegetable diet
The men in Group B will receive standard dietary guidelines and regularly scheduled newsletters over the same 24 months. (The newsletters will contain established general information about diet and a healthy lifestyle.)
Effectively the trial is designed to test whether a high-vegetable diet will lower risk for prostate cancer progression compared to a “standard” diet.
The trial will enroll 464 men who will be followed for 5 years, with careful and regular assessment of their PSA levels and scheduled and other appropriate repeat biopsies.
Other things that will be studied among the trial participants will include treatment-seeking behaviors, anxiety, health-related quality of life, and levels of a variety of tissue biomarkers.