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

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

Sponsors

Lead Sponsor: Alliance for Clinical Trials in Oncology

Collaborator: National Cancer Institute (NCI)

Source Alliance for Clinical Trials in Oncology
Brief Summary

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.

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.

Overall Status Completed
Start Date January 2011
Completion Date January 15, 2019
Primary Completion Date November 18, 2017
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Time to Progression Up to 2 years
Secondary Outcome
Measure Time Frame
Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed Up to 2 years
Quality of Life (QOL) Was Measured Using Change From Baseline in Total Summary Score of Memorial Anxiety Scale for Prostate Cancer (MAX-PC) at Month 24 Up to 2 years
Total Vegetables (Servings Per Day) Evaluated at Baseline and Month 24 Based on Dietary Recall Up to 2 years
Enrollment 478
Condition
Intervention

Intervention Type: Other

Intervention Name: dietary education and counseling

Arm Group Label: Arm A - MEAL Program Intervention

Intervention Type: Other

Intervention Name: prostate cancer foundation booklet

Arm Group Label: Arm B - Prostate Cancer Foundation Booklet

Eligibility

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.

Gender: Male

Minimum Age: 50 Years

Maximum Age: 80 Years

Healthy Volunteers: No

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

United States

Verification Date

February 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Arm A - MEAL Program Intervention

Type: Experimental

Description: Patients will receive dietary education and telephone counseling sessions over 24 months.

Label: Arm B - Prostate Cancer Foundation Booklet

Type: Experimental

Description: Patients receive information about diet, nutrition, exercise and cancer. Patients also receive regularly scheduled newsletters.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov