Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01238172
First received: November 9, 2010
Last updated: August 20, 2015
Last verified: August 2015
  Purpose

RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer.

PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.


Condition Intervention
Prostate Cancer
Other: dietary education and counseling
Other: prostate cancer foundation booklet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Men's Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer Patients on Active Surveillance

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • disease progression [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to progression [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • time to treatment [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • dietary recall evaluated at baseline, month 12 and month 24 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 464
Study Start Date: January 2011
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A - MEAL Program Intervention
Patients will receive dietary education and telephone counseling sessions over 24 months.
Other: dietary education and counseling
Experimental: Arm B - Prostate Cancer Foundation Booklet
Patients receive information about diet, nutrition, exercise and cancer. Patients also receive regularly scheduled newsletters.
Other: prostate cancer foundation booklet

Detailed Description:

CALGB 70807 is a randomized, phase III clinical trial designed to test this practical, diet-based intervention for prostate cancer in a broader clinical setting. Patients on AS will be randomized either to an intervention of centralized, telephone-based dietary counseling and structured dietary education or to a comparison control condition in which they receive the Prostate Cancer Foundation booklet. Study endpoints will include disease progression, incidence of treatment, and health-related quality of life.

OBJECTIVES:

Primary

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

Secondary

  • To compare the incidence of active treatment (surgery, irradiation, local ablation, or androgen deprivation) in AS patients receiving dietary intervention compared to no intervention.
  • 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 (black or african american vs other), and baseline prostate biopsy (0-12 months before registration vs > 12-24 months before registration). Patients are randomized to 1 of 2 treatment arms. Please see the arms section for more information.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Preregistration Eligibility:

  1. Histologic Documentation:

    • The initial biopsy showing diagnosis of prostate cancer should be used for the purposes of determining eligibility.
    • However, if a subsequent biopsy performed before patient enrollment shows that the patient is ineligible, he may not be enrolled to the study.
    • Eligible patients must meet all of the following criteria:

      • Biopsy-proven (consisting of ≥ 10 tissue cores) adenocarcinoma of the prostate diagnosed within 24 months prior to pre-registration
      • < 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
    • NOTE: If a patient undergoes a transurethral resection of the prostate (TURP) for benign prostatic hyperplasia (BPH), and prostate cancer is diagnosed incidentally from the TURP specimen, eligibility for CALGB 70807 cannot be determined from the TURP specimen. However, if the patient subsequently undergoes a minimum 10-core prostate biopsy within 2 years of prostate cancer diagnosis from the TURP, and prostate cancer is detected in the biopsy specimen and meets the requirements above, the patient is eligible for this study. If prostate cancer is not detected in the biopsy specimen, the patient is not eligible.
  2. Prior Treatment: 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.
  3. Patients who have had a history of non-cutaneous malignancy (other than nonmelanoma skin cancer) in the previous 5 years are not eligible.
  4. Language: Patients must be able to read and comprehend English language text and be able to understand spoken English over the phone.
  5. Life expectancy of at least 3 years
  6. Patients who are currently taking vitamin supplements including lycopene and beta-carotene are eligible.
  7. Patients receiving treatment with 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) within 90 days prior to preregistration are not eligible. Treatment with these agents during the protocol intervention is not permitted.
  8. Patients who are currently taking coumadin are not eligible.
  9. Participants will be men aged 50 to 80 years.
  10. For men ≤ 70 years, biopsy Gleason score ≤ 6; for men > 70 years, biopsy Gleason score ≤ (3 + 4) = 7.
  11. Required Initial Laboratory Values:

    • Serum PSA < 10 ng/mL
    • NOTE: Baseline PSA for determination of eligibility must be measured after discontinuation of any 5-alpha reductase inhibitors.

Registration Eligibility:

  1. Successful completion of three 24-hour dietary recalls during the run-in period.
  2. Patients consuming ≥ 6 servings per day of fruits and vegetables (not including juices), as determined by the run-in dietary recalls are not eligible.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238172

  Hide Study Locations
Locations
United States, Alaska
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, California
Kaiser Permanente Medical Center - Bellflower
Bellflower, California, United States, 90706
California Cancer Care, Incorporated - Greenbrae
Greenbrae, California, United States, 94904
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States, 90027
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Saint Helena Hospital
Saint Helena, California, United States, 94574
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
San Diego, California, United States, 92120
Naval Medical Center - San Diego
San Diego, California, United States, 92134
Veterans Affairs Medical Center - San Diego
San Diego, California, United States, 92161
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
United States, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Middlesex Hospital Cancer Center
Middletown, Connecticut, United States, 06457
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States, 33805
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
Cleveland Clinic Florida - Weston
Weston, Florida, United States, 33331
United States, Hawaii
Kapiolani Medical Center at Pali Momi
Aiea, Hawaii, United States, 96701
Oncare Hawaii, Incorporated - Pali Momi
Aiea, Hawaii, United States, 96701
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, United States, 96813
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, United States, 96817-3169
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii, United States, 96813
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Castle Medical Center
Kailua, Hawaii, United States, 96734
Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
St. Joseph Regional Medical Center
Lewiston, Idaho, United States, 83501
Idaho Urologic Institute, PA
Meridian, Idaho, United States, 83642
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Resurrection Medical Center
Chicago, Illinois, United States, 60631
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Veterans Affairs Medical Center - Hines
Hines, Illinois, United States, 60141
La Grange Memorial Hospital
La Grange, Illinois, United States, 60525
West Suburban Center for Cancer Care
River Forest, Illinois, United States, 60305
United States, Indiana
Bloomington Hospital Regional Cancer Institute
Bloomington, Indiana, United States, 47403
Elkhart Clinic, LLC
Elkhart, Indiana, United States, 46514-2098
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States, 46514
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States, 46563
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States, 46391
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Wendt Regional Cancer Center at Finley Hospital
Dubuque, Iowa, United States, 52001
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51102
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
St. Rose Ambulatory and Surgery Center
Great Bend, Kansas, United States, 67530
Hays Medical Center
Hays, Kansas, United States, 67601
Hutchinson Hospital Corporation
Hutchinson, Kansas, United States, 67502
Kansas City Cancer Centers - West
Kansas City, Kansas, United States, 66112
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, United States, 66210
Mount Carmel Regional Cancer Center
Pittsburg, Kansas, United States, 66762
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States, 67401
Kansas City Cancer Center - Shawnee Mission
Shawnee Mission, Kansas, United States, 66204
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States, 66606
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
United States, Louisiana
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States, 70112
United States, Maine
Maine Medical Center - Bramhall Campus
Portland, Maine, United States, 04102
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States, 04074
York Hospital's Oncology Treatment Center
York, Maine, United States, 03909
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy General Health Partners
Muskegon, Michigan, United States, 49444
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States, 56303
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
Adult and Pediatric Urology, PLLP
Sartell, Minnesota, United States, 56377
United States, Missouri
Kansas City Cancer Centers - South
Kansas City, Missouri, United States, 64131
Kansas City Cancer Centers - North
Kansas City, Missouri, United States, 64154
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States, 64108
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States, 64128
Kansas City Cancer Centers - East
Lee's Summit, Missouri, United States, 64064
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, Montana
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59102
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
St. Peter's Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States, 03103
Foundation Medical Partners
Nashua, New Hampshire, United States, 03060
United States, New Jersey
Saint Clare's Hospital
Denville, New Jersey, United States, 07834
Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
Somerset Medical Center
Somerville, New Jersey, United States, 08876
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
Monter Cancer Center of the North Shore-LIJ Health System
Lake Success, New York, United States, 11042
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States, 11030
Mount Kisco Medical Group, PC
Mount Kisco, New York, United States, 10549-3417
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
High Point Regional Hospital
High Point, North Carolina, United States, 27261
United States, Ohio
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Bay Area Hospital
Coos Bay, Oregon, United States, 97420
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
Cancer Center at Phoenixville Hospital
Phoenixville, Pennsylvania, United States, 19460
United States, Texas
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
University Hospital - San Antonio
San Antonio, Texas, United States, 78229
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78209
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Auburn Regional Center for Cancer Care
Auburn, Washington, United States, 98002
Overlake Cancer Center at Overlake Hospital Medical Center
Bellevue, Washington, United States, 98004
Providence Centralia Hospital
Centralia, Washington, United States, 98531-9027
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
St. Francis Hospital
Federal Way, Washington, United States, 98003
Cascade Cancer Center at Evergreen Hospital Medical Center
Kirkland, Washington, United States, 98033
Seattle Cancer Care Alliance at EvergreenHealth
Kirkland, Washington, United States, 98034
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States, 98506-5166
Good Samaritan Cancer Center
Puyallup, Washington, United States, 98372
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Pacific Medical Center
Seattle, Washington, United States, 98104
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Allenmore Hospital
Tacoma, Washington, United States, 98405
CCOP - Northwest
Tacoma, Washington, United States, 98405
Franciscan Cancer Center at St. Joseph Medical Center
Tacoma, Washington, United States, 98405-3004
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States, 98431
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States, 98405
St. Clare Hospital
Tacoma, Washington, United States, 98499
United States, Wisconsin
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
D.N. Greenwald Center
Mukwonago, Wisconsin, United States, 53149
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: J. Kellogg Parsons, MD, MHS University of California, San Diego
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01238172     History of Changes
Other Study ID Numbers: CALGB-70807, CALGB-70807, CDR0000687958
Study First Received: November 9, 2010
Last Updated: August 20, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Disease Progression
Prostatic Neoplasms
Disease Attributes
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on August 27, 2015