Know Cancer

forgot password

The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance

50 Years
80 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance



- To determine if a telephone-based dietary intervention compared to no intervention will
decrease clinical progression in AS patients.


- To compare the incidence of active treatment (surgery, irradiation, local ablation, or
androgen deprivation) in AS patients receiving dietary intervention compared to no

- To compare prostate cancer-related anxiety in AS patients receiving dietary
intervention compared to no intervention.

- To compare health-related quality of life in AS patients receiving dietary intervention
compared to no intervention.

OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 70 years
vs > 70 years), race (African American vs other), and time of baseline prostate biopsy (0-12
months before registration vs > 12-24 months before registration). Patients are randomized
to 1 of 2 treatment arms.

- Arm I: Patients receive the MEAL program intervention with dietary education and
telephone counseling sessions for 24 months. Patients receive the "Participant
Notebook", which provides written material describing the counseling program. It also
outlines the dietary targets, offers supporting information on strategies to achieve
these targets, supplies referent tools to help patients accurately estimate servings of
target foods, and offers recipes and articles about diet and prostate cancer. The
counseling sessions are divided into 4 phases, with the first three phases completed in
7 months and the fourth phase continuing for 17 months. The first phase comprises 6
counseling calls focusing on education and the rapid development of self-efficacy, the
second phase comprises 4 calls over a 2-month period focusing on practical and
consistent implementation of the dietary pattern, the third phase comprises 4 calls
over a 4-month period helping patients habituate to the dietary pattern by providing
regular performance reviews, and the fourth phase comprises 8 calls over a 17-month
period and is a maintenance phase. Patients are encouraged to achieve 7 servings per
day of vegetables (2 cruciferous, 2 tomato products, 3 other vegetables), 2 servings
per day of whole grains, 1 serving per day of beans or other legumes, and 2 servings
per day of fruit. Patients also receive 8 regularly scheduled newsletters over the
course of 24 months. The newsletters focus on study goals and progress and provide tips
on achieving and maintaining diet change. They also include information on diet and
cancer, the challenges of diet change, the advances in prostate cancer control, and new

- Arm II: Patients receive standard United States Department of Agriculture dietary
guidelines for Americans. Patients also receive 8 regularly scheduled newsletters over
the course of 24 months. The newsletters contain general information about diet and
healthy lifestyle.

Blood (plasma and serum) and tissue samples are collected at baseline and at 12 and 24
months for biomarker and pharmacogenomic studies.

Patients complete quality-of-life assessments (Personal Habits Questionnaire, Functional
Assessment of Cancer Therapy Scale-Prostate (FACT-P), Memorial Anxiety Scare for Prostate
Cancer (Max-PC), International Prostate Symptom Score (IPSS), Expanded Prostate Cancer Index
Composite 26 (EPIC-26), and Nutrition Self-Efficacy and Satisfaction with the MEAL Program)
at baseline and at 6, 12, 18, and 24 months.

After study entry, patients are followed up every 3 months for 2 years.

Inclusion Criteria


- Biopsy-proven (consisting of ≥ 10 tissue cores) adenocarcinoma of the prostate
diagnosed within 24 months prior to presentation

- < 25% of biopsy tissue cores positive for cancer

- ≤ 50% of any one biopsy tissue core positive for cancer

- Clinical stage ≤ T2a

- Patients who have prostate cancer with distant metastases are not eligible

- For men ≤ 70 years, biopsy Gleason score ≤ 6; for men > 70 years, biopsy Gleason
score ≤ (3 + 4) = 7

- Serum PSA < 10 ng/mL

- Baseline PSA for determination of eligibility must be measured after
discontinuation of any 5-alpha reductase inhibitors

- Patients are offered registration to the correlative study CALGB-151105


- Life expectancy of at least 3 years

- Patients must be able to read and comprehend English language text and be able to
understand spoken English over the phone

- Patients who have had a history of non-cutaneous malignancy (other than nonmelanoma
skin cancer) in the previous 5 years are not eligible

- Successful completion of three 24-hour dietary recalls during the run-in period


- Patients who have had prior treatment for prostate cancer by surgery, irradiation,
local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or
androgen-deprivation therapy are not eligible

- Patients who are currently taking vitamin supplements including lycopene and
beta-carotene are eligible

- Patients who are currently taking coumadin are not eligible

- Patients consuming ≥ 6 servings per day of fruits and vegetables (not including
juices), as measured by the run-in dietary recalls, are not eligible

- Patients receiving treatment with 5-alpha reductase inhibitors within 90 days prior
to preregistration are not eligible

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression defined by PSA doubling time (PSADT) < 3 years, PSA > 10 at any time, or Gleason sum on repeat biopsy ≥ 7 (for men < 70 years) or ≥ 4+3 = 7 (for men ≥ 70 year)

Outcome Time Frame:

Up to 2 years

Safety Issue:


Principal Investigator

J. Kellogg Parsons, MD, MHS

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Diego


United States: Institutional Review Board

Study ID:




Start Date:

January 2011

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms
  • Disease Progression



Roswell Park Cancer Institute Buffalo, New York  14263
Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic Cancer Center Rochester, Minnesota  55905
University of Chicago Cancer Research Center Chicago, Illinois  60637
Hurley Medical Center Flint, Michigan  48503
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - North Shore University Hospital Manhasset, New York  11030
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
Kaiser Permanente Medical Center - Los Angeles Los Angeles, California  90027
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Montana Cancer Consortium Billings, Montana  59101
Virginia Mason Medical Center Seattle, Washington  98111
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma, Washington  98405
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
CCOP - Virginia Mason Research Center Seattle, Washington  98101
CCOP - Northwest Tacoma, Washington  98405-0986
Naval Medical Center - San Diego San Diego, California  92134-3202
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
Veterans Affairs Medical Center - San Diego San Diego, California  92161
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
West Suburban Center for Cancer Care River Forest, Illinois  60305
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Maine Center for Cancer Medicine and Blood Disorders - Scarborough Scarborough, Maine  04074
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
Waukesha Memorial Hospital Regional Cancer Center Waukesha, Wisconsin  53188
Long Island Jewish Medical Center New Hyde Park, New York  11040
Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda, California  92354
Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando, Florida  32803-1273
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Somerset Medical Center Somerville, New Jersey  08876
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
William Beaumont Hospital - Royal Oak Campus Royal Oak, Michigan  48073
Munson Medical Center Traverse City, Michigan  49684
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Veterans Affairs Medical Center - Hines Hines, Illinois  60141
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Los Angeles, California  90048-1865
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset, New York  11030
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Madigan Army Medical Center - Tacoma Tacoma, Washington  98431
Gundersen Lutheran Center for Cancer and Blood La Crosse, Wisconsin  54601
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego San Diego, California  92120
Huntsman Cancer Institute at University of Utah Salt Lake City, Utah  84112
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
Maine Medical Center - Bramhall Campus Portland, Maine  04102
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
Front Range Cancer Specialists Fort Collins, Colorado  80528
Lakeland Regional Cancer Center at Lakeland Regional Medical Center Lakeland, Florida  33805
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Poudre Valley Hospital Fort Collins, Colorado  80524
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise, Idaho  83706
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
St. Francis Comprehensive Cancer Center Topeka, Kansas  66606
Mary Bird Perkins Cancer Center - Baton Rouge Baton Rouge, Louisiana  70809
Medical Center of Louisiana - New Orleans New Orleans, Louisiana  70112
Mecosta County Medical Center Big Rapids, Michigan  49307
Coborn Cancer Center Saint Cloud, Minnesota  56303
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Cancer Therapy and Research Center San Antonio, Texas  78229
University Hospital - San Antonio San Antonio, Texas  78229
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital Fairbanks, Alaska  99701
St. Francis Hospital Federal Way, Washington  98003
Cascade Cancer Center at Evergreen Hospital Medical Center Kirkland, Washington  98034-3013
St. Clare Hospital Lakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer Center Olympia, Washington  98506
Good Samaritan Cancer Center Puyallup, Washington  98371
Allenmore Hospital Tacoma, Washington  98411-0414
Middlesex Hospital Cancer Center Middletown, Connecticut  06457
Wendt Regional Cancer Center at Finley Hospital Dubuque, Iowa  52001
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Michiana Hematology-Oncology, PC - Elkhart Elkhart, Indiana  46514
Elkhart Clinic, LLC Elkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La Porte La Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South Bend Mishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - Plymouth Plymouth, Indiana  46563
McFarland Clinic, PC Ames, Iowa  50010
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Lakeside Cancer Specialists, PLLC Saint Joseph, Michigan  49085
Truman Medical Center - Hospital Hill Kansas City, Missouri  64108
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Monter Cancer Center of the North Shore-LIJ Health System Lake Success, New York  11042
Providence Centralia Hospital Centralia, Washington  98531-9027
Franciscan Cancer Center at St. Joseph Medical Center Tacoma, Washington  98405-3004
Rocky Mountain Oncology Casper, Wyoming  82609
Auburn Regional Center for Cancer Care Auburn, Washington  98002
Genesys Regional Medical Center Grand Blanc, Michigan  48439-8066
Queen's Cancer Institute at Queen's Medical Center Honolulu, Hawaii  96813
Elliot Regional Cancer Center at Elliot Hospital Manchester, New Hampshire  03103
Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center Englewood, New Jersey  07631
Pardee Memorial Hospital Hendersonville, North Carolina  28791
Regional Cancer Center at Oconomowoc Memorial Hospital Oconomowoc, Wisconsin  53066
Union Hospital of Cecil County Elkton MD, Maryland  21921
Kaiser Permanente Medical Center - Bellflower Bellflower, California  90706
Resurrection Medical Center Chicago, Illinois  60631
La Grange Memorial Hospital La Grange, Illinois  60525
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Cancer Center at Phoenixville Hospital Phoenixville, Pennsylvania  19460
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Straub Clinic and Hospital, Incorporated Honolulu, Hawaii  96813
OnCare Hawaii, Incorporated - Kuakini Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Lusitana Honolulu, Hawaii  96813
York Hospital's Oncology Treatment Center York, Maine  03909
Mercy General Health Partners Muskegon, Michigan  49443
Bay Area Hospital Coos Bay, Oregon  97420
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045
Cleveland Clinic Florida - Weston Weston, Florida  33331
High Point Regional Hospital High Point, North Carolina  27261
Mount Carmel Regional Cancer Center Pittsburg, Kansas  66762
California Cancer Care, Incorporated - Greenbrae Greenbrae, California  94904
Foundation Medical Partners Nashua, New Hampshire  03060
Kansas City Cancer Centers - Southwest Overland Park, Kansas  66210
Castle Medical Center Kailua, Hawaii  96734
Kauai Medical Clinic Lihue, Hawaii  96766
Hays Medical Center Hays, Kansas  67601
Hutchinson Hospital Corporation Hutchinson, Kansas  67502
Saint Helena Hospital Saint Helena, California  94574
Pacific Medical Center Seattle, Washington  98104
Overlake Cancer Center at Overlake Hospital Medical Center Bellevue, Washington  98004
Kansas City Cancer Centers - North Kansas City, Missouri  64154
Bloomington Hospital Regional Cancer Institute Bloomington, Indiana  47403
Kansas City Cancer Centers - South Kansas City, Missouri  64131
St. Rose Ambulatory and Surgery Center Great Bend, Kansas  67530
Kansas City Cancer Centers - West Kansas City, Kansas  66112
Kansas City Cancer Center - Shawnee Mission Shawnee Mission, Kansas  66204
Kansas City Cancer Centers - East Lee's Summit, Missouri  64064
Spectrum Health Reed City Hospital Reed City, Michigan  49677
Providence Regional Cancer Partnership Everett, Washington  98201
Adult and Pediatric Urology, PLLP Sartell, Minnesota  56377
Mount Kisco Medical Group, PC Mount Kisco, New York  10549
St. Joseph Regional Medical Center Lewiston, Idaho  83501
Walter Reed National Military Medical Center Bethesda, Maryland  20889
D.N. Greenwald Center Mukwonago, Wisconsin  53149
Idaho Urologic Institute, PA Meridian, Idaho  83642
Oncare Hawaii, Incorporated - Pali Momi Aiea, Hawaii  96701
Benefis Sletten Cancer Institute Great Falls, Montana  59405
Seattle Cancer Care Alliance at EvergreenHealth Kirkland, Washington  98034
Saint Clare's Hospital Denville, New Jersey  07834