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Randomized Controlled Trial
. 2020 Jan 14;323(2):140-148.
doi: 10.1001/jama.2019.20207.

Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial

J Kellogg Parsons  1 , David Zahrieh  2 , James L Mohler  3 , Electra Paskett  4 , Donna E Hansel  5 , Adam S Kibel  6 , Heshan Liu  2 , Drew K Seisler  2 , Loki Natarajan  7 , Martha White  7 , Olwen Hahn  8 , John Taylor  8 , Sheri J Hartman  9 , Sean P Stroup  10 , Peter Van Veldhuizen  11 , Lannis Hall  12 , Eric J Small  13 , Michael J Morris  14 , John P Pierce  9 , James Marshall  15
Affiliations
Randomized Controlled Trial

Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial

J Kellogg Parsons et al. JAMA. .

Abstract

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 <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level less than 10 ng/mL. Enrollment occurred from January 2011 to August 2015; 24-month follow-up occurred from January 2013 to August 2017.

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Parsons reported receiving grants from the National Cancer Institute (NCI) and personal fees from Endocare and INSIGHTEC outside the submitted work and owning stock in Pfizer and Johnson & Johnson. Dr Mohler reported receiving grants from the NCI, US Department of Defense, and the Prostate Cancer Foundation during the conduct of the study and grants from the NCI, Department of Defense, and the National Institute of Diabetes and Digestive and Kidney Diseases and personal fees from the National Comprehensive Cancer Network outside the submitted work. Dr Paskett reported receiving grants from the NCI during the conduct of the study and grants from the Merck Foundation outside the submitted work, and owning stock in Pfizer. Dr Kibel reported receiving personal fees from Janssen, Bristol-Myers Squibb, Merck, INSIGHTEC, and Profound outside the submitted work. Dr Hahn reported receiving personal fees from Via Oncology outside the submitted work. Dr Stroup reported receiving CALGB 70807 funding paid through the Henry Jackson Foundation. Dr Small reported receiving personal fees from Janssen Pharmaceuticals, Harpoon Therapeutics, Fortis Therapeutics, and BeiGene Therapeutics outside the submitted work. Dr Morris reported receiving personal fees from Blue Earth Diagnostics, Advanced Accelerator Applications, Tokai Pharmaceuticals, and ORIC Pharmaceuticals outside the submitted work and travel funding from Bayer, Endocyte, and Fujifilm, as well as funding paid to his institution for his participation in clinical trials for Bayer, Endocyte, Progenics Pharmaceuticals, Corcept Therapeutics, Roche, and Janssen. Dr Pierce reported receiving grants from the NCI and Alliance Cooperative Group during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Recruitment, Randomization, and Patient Flow
aThe unmet eligibility criteria were not captured as part of the protocol. bCentralized pathology review was conducted by a single pathologist on tissue specimens collected at diagnosis to determine tumor volume and Gleason scores. cThe unmet inclusion criteria included baseline prostate-specific antigen level greater than 10 ng/mL (n = 1) and more than 25% biopsy tissue cores positive for cancer (n = 1). dThe unmet inclusion criteria included baseline prostate-specific antigen level greater than 10 ng/mL (n = 1), more than 25% biopsy tissue cores positive for cancer (n = 2), Gleason score of 7 for men aged 70 years or younger (n = 1), and consumed 6 or more servings per day of fruits and vegetables (n = 1).
Figure 2.
Figure 2.. Time to Progression Where Progression Was Defined as Prostate-Specific Antigen Level ≥10 ng/mL, Prostate-Specific Antigen Doubling Time <3 Years, or Upgrading on Follow-up Prostate Biopsy (A) and Upgrading on Follow-up Prostate Biopsy (B)
A, The median follow-up time was 24.1 months (interquartile range [IQR], 22.7-24.7) for the MEAL intervention group and 24.0 months (IQR, 22.9-24.6) for the control group. B, The median follow-up time was 23.9 months (IQR, 22.4-24.5) for the MEAL intervention group and 23.9 months (IQR, 22.1-24.6) for the control group.
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