A randomized trial of diet in men with early stage prostate cancer on active surveillance: rationale and design of the Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]).
BACKGROUND
Diet may substantially alter prostate cancer initiation and progression. However, large-scale clinical trials of diet modification have yet to be performed for prostate cancer. The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) is investigating the effect of increased vegetable consumption on clinical progression in men with localized prostate cancer.


METHODS
MEAL is a randomized, phase III clinical trial designed to test whether an intervention that increases vegetable intake will decrease the incidence of clinical progression in men with clinically localized prostate cancer on active surveillance. We are randomizing 464 patients to either a validated telephone-based diet counseling intervention or a control condition in which patients receive a published diet guideline. The intervention will continue for two years. The primary outcome variable is clinical progression defined by serum prostate-specific antigen (PSA) and pathological findings on follow-up prostate biopsy. Secondary outcome variables include incidence of surgical and non-surgical treatments for prostate cancer, prostate-cancer related patient anxiety and health-related quality of life.


CONCLUSIONS
The MEAL Study is assessing the effectiveness of a high-vegetable diet intervention for preventing clinical progression in men with localized prostate cancer on active surveillance.
Division of Urologic Oncology, UC San Diego Moores Cancer Center, La Jolla, CA, United States; Department of Urology, UC San Diego Health System, La Jolla, CA, United States; VA San Diego Healthcare System, La Jolla, CA, United States. Electronic address: jkparsons@ucsd.edu.
J Kellogg
JK
Parsons
Department of Family and Preventive Medicine, University of California, San Diego School of Medicine, La Jolla, CA, United States.
John P
JP
Pierce
Department of Urology, Roswell Park Cancer Institute, Buffalo, NY, United States.
James
J
Mohler
Department of Medicine, College of Medicine, Comprehensive Cancer Center, Ohio State University, Columbus, OH, United States.
Electra
E
Paskett
Alliance Statistics and Data Center, Duke University Medical Center, Durham, NC, United States.
Sin-Ho
SH
Jung
Department of Pathology, Washington University Medical School, St. Louis, MO, United States.
Peter
P
Humphrey
Alliance Central Protocol Operations, University of Chicago, Chicago, IL, United States.
John R
JR
Taylor
Department of Family and Preventive Medicine, University of California, San Diego School of Medicine, La Jolla, CA, United States.
Vicky A
VA
Newman
Department of Family and Preventive Medicine, University of California, San Diego School of Medicine, La Jolla, CA, United States.
Leslie
L
Barbier
Department of Family and Preventive Medicine, University of California, San Diego School of Medicine, La Jolla, CA, United States.
Cheryl L
CL
Rock
Department of Prevention and Population Sciences, Roswell Park Cancer Institute, Buffalo, NY, United States.
James
J
Marshall
D000368:Aged; D000369:Aged, 80 and over; D003376:Counseling / Q000379:methods*; D004035:Diet Therapy / Q000379:methods*; D018450:Disease Progression; D006801:Humans; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen; D011471:Prostatic Neoplasms / Q000628:therapy*; D011788:Quality of Life; D012107:Research Design; D013689:Telephone; D014675:Vegetables
D017430:Prostate-Specific Antigen
Active surveillance; Carotenoids; Diet; Nutrition; Outcomes; Prostate cancer