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Importance Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data. Objective To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression in men with early-stage prostate cancer. Design, Setting, and Participants The Men’s Eating and Living (MEAL) Study (CALGB 70807 Alliance) was a randomized clinical trial conducted at 91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group = 1 in those Interventions Patients were randomized to a counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n = 237) or a control group, which received written information about diet and prostate cancer (n = 241). Main Outcomes and Measures The primary outcome was time to progression; progression was defined as PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade) on follow-up prostate biopsy. Results Among 478 patients randomized (mean SD age, 64 7 years; mean SD PSA level, 4.9 2.1 ng/mL), 443 eligible patients (93%) were included in the primary analysis. There were 245 progression events (intervention: 124; control: 121). There were no significant differences in time to progression (unadjusted hazards ratio, 0.96 95% CI, 0.75 to 1.24; adjusted hazard ratio, 0.97 95% CI, 0.76 to 1.25). The 24-month Kaplan-Meier progression-free percentages were 43.5% 95% CI, 36.5% to 50.6% and 41.4% 95% CI, 34.3% to 48.7% for the intervention and control groups, respectively (difference, 2.1% 95% CI, −8.1% to 12.2%). Conclusions and Relevance Among men with early-stage prostate cancer managed with active surveillance, a behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression. The findings do not support use of this intervention to decrease prostate cancer progression in this population, although the study may have been underpowered to identify a clinically important difference. Trial Registration ClinicalTrials.gov Identifier:NCT01238172
Parsons et al. (Tue,) studied this question.