Clinical trial NCT01238172: Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
adenocarcinoma of the prostate
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-11-10
Enrollment: 478
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time to Progression
timeFrame: Up to 2 years
Secondary outcomes:
measure: Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed
timeFrame: Up to 2 years
measure: 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
timeFrame: Up to 2 years
measure: Total Vegetables (Servings Per Day) Evaluated at Baseline and Month 24 Based on Dietary Recall
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Fairbanks
country: United States
facility: Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
state: Alaska
city: Scottsdale
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Bellflower
country: United States
facility: Kaiser Permanente Medical Center - Bellflower
state: California
city: Greenbrae
country: United States
facility: California Cancer Care, Incorporated - Greenbrae
state: California
city: La Jolla
country: United States
facility: Rebecca and John Moores UCSD Cancer Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Cancer Institute at Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Medical Center - Los Angeles
state: California
city: Los Angeles
country: United States
facility: Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
state: California
city: Saint Helena
country: United States
facility: Saint Helena Hospital
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
state: California
city: San Diego
country: United States
facility: Naval Medical Center - San Diego
state: California
city: San Diego
country: United States
facility: Veterans Affairs Medical Center - San Diego
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center at UC Health Sciences Center
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Hospital
state: Colorado
city: Fort Collins
country: United States
facility: Front Range Cancer Specialists
state: Colorado
city: Hartford
country: United States
facility: Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
state: Connecticut
city: Middletown
country: United States
facility: Middlesex Hospital Cancer Center
state: Connecticut
city: Lewes
country: United States
facility: Tunnell Cancer Center at Beebe Medical Center
state: Delaware
city: Newark
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center at Lakeland Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute at Florida Hospital Orlando
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida - Weston
state: Florida
city: 'Aiea
country: United States
facility: Kapiolani Medical Center at Pali Momi
state: Hawaii
city: 'Aiea
country: United States
facility: Oncare Hawaii, Incorporated - Pali Momi
state: Hawaii
city: Honolulu
country: United States
facility: Cancer Research Center of Hawaii
state: Hawaii
city: Honolulu
country: United States
facility: OnCare Hawaii, Incorporated - Lusitana
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Cancer Institute at Queen's Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Straub Clinic and Hospital, Incorporated
state: Hawaii
city: Honolulu
country: United States
facility: OnCare Hawaii, Incorporated - Kuakini
state: Hawaii
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Kailua
country: United States
facility: Castle Medical Center
state: Hawaii
city: Lihue
country: United States
facility: Kauai Medical Clinic
state: Hawaii
city: Boise
country: United States
facility: Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
state: Idaho
city: Lewiston
country: United States
facility: St. Joseph Regional Medical Center
state: Idaho
city: Meridian
country: United States
facility: Idaho Urologic Institute, PA
state: Idaho
city: Chicago
country: United States
facility: Resurrection Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Chicago
country: United States
facility: Louis A. Weiss Memorial Hospital
state: Illinois
city: Hines
country: United States
facility: Veterans Affairs Medical Center - Hines
state: Illinois
city: La Grange
country: United States
facility: La Grange Memorial Hospital
state: Illinois
city: River Forest
country: United States
facility: West Suburban Center for Cancer Care
state: Illinois
city: Bloomington
country: United States
facility: Bloomington Hospital Regional Cancer Institute
state: Indiana
city: Elkhart
country: United States
facility: Elkhart Clinic, LLC
state: Indiana
city: Elkhart
country: United States
facility: Michiana Hematology-Oncology, PC - Elkhart
state: Indiana
city: Elkhart
country: United States
facility: Elkhart General Hospital
state: Indiana
city: Kokomo
country: United States
facility: Howard Community Hospital
state: Indiana
city: La Porte
country: United States
facility: Center for Cancer Therapy at LaPorte Hospital and Health Services
state: Indiana
city: Mishawaka
country: United States
facility: Michiana Hematology-Oncology, PC - South Bend
state: Indiana
city: Mishawaka
country: United States
facility: Saint Joseph Regional Medical Center
state: Indiana
city: Plymouth
country: United States
facility: Michiana Hematology Oncology PC - Plymouth
state: Indiana
city: South Bend
country: United States
facility: CCOP - Northern Indiana CR Consortium
state: Indiana
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: Westville
country: United States
facility: Michiana Hematology Oncology PC - La Porte
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic, PC
state: Iowa
city: Dubuque
country: United States
facility: Wendt Regional Cancer Center at Finley Hospital
state: Iowa
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at University of Iowa
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Associates, LLP
state: Iowa
city: Sioux City
country: United States
facility: Mercy Medical Center - Sioux City
state: Iowa
city: Sioux City
country: United States
facility: St. Luke's Regional Medical Center
state: Iowa
city: Great Bend
country: United States
facility: St. Rose Ambulatory and Surgery Center
state: Kansas
city: Hays
country: United States
facility: Hays Medical Center
state: Kansas
city: Hutchinson
country: United States
facility: Hutchinson Hospital Corporation
state: Kansas
city: Kansas City
country: United States
facility: Kansas City Cancer Centers - West
state: Kansas
city: Kansas City
country: United States
facility: Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Kansas City Cancer Centers - Southwest
state: Kansas
city: Pittsburg
country: United States
facility: Mount Carmel Regional Cancer Center
state: Kansas
city: Salina
country: United States
facility: Tammy Walker Cancer Center at Salina Regional Health Center
state: Kansas
city: Shawnee Mission
country: United States
facility: Kansas City Cancer Center - Shawnee Mission
state: Kansas
city: Topeka
country: United States
facility: St. Francis Comprehensive Cancer Center
state: Kansas
city: Lexington
country: United States
facility: Lucille P. Markey Cancer Center at University of Kentucky
state: Kentucky
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center - Baton Rouge
state: Louisiana
city: New Orleans
country: United States
facility: MBCCOP - LSU Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Medical Center of Louisiana - New Orleans
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center - Bramhall Campus
state: Maine
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine and Blood Disorders - Scarborough
state: Maine
city: York
country: United States
facility: York Hospital's Oncology Treatment Center
state: Maine
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Elkton
country: United States
facility: Union Hospital of Cecil County
state: Maryland
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Cancer Center
state: Michigan
city: Ann Arbor
country: United States
facility: CCOP - Michigan Cancer Research Consortium
state: Michigan
city: Battle Creek
country: United States
facility: Battle Creek Health System Cancer Care Center
state: Michigan
city: Big Rapids
country: United States
facility: Mecosta County Medical Center
state: Michigan
city: Dearborn
country: United States
facility: Oakwood Cancer Center at Oakwood Hospital and Medical Center
state: Michigan
city: Flint
country: United States
facility: Genesys Hurley Cancer Institute
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Butterworth Hospital at Spectrum Health
state: Michigan
city: Grand Rapids
country: United States
facility: CCOP - Grand Rapids
state: Michigan
city: Grand Rapids
country: United States
facility: Lacks Cancer Center at Saint Mary's Health Care
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Van Elslander Cancer Center at St. John Hospital and Medical Center
state: Michigan
city: Jackson
country: United States
facility: Foote Memorial Hospital
state: Michigan
city: Lansing
country: United States
facility: Sparrow Regional Cancer Center
state: Michigan
city: Livonia
country: United States
facility: St. Mary Mercy Hospital
state: Michigan
city: Muskegon
country: United States
facility: Mercy General Health Partners
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy Oakland
state: Michigan
city: Port Huron
country: United States
facility: Mercy Regional Cancer Center at Mercy Hospital
state: Michigan
city: Reed City
country: United States
facility: Spectrum Health Reed City Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital - Royal Oak Campus
state: Michigan
city: Saginaw
country: United States
facility: Seton Cancer Institute at Saint Mary's - Saginaw
state: Michigan
city: Saint Joseph
country: United States
facility: Lakeland Regional Cancer Care Center - St. Joseph
state: Michigan
city: Saint Joseph
country: United States
facility: Lakeside Cancer Specialists, PLLC
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Warren
country: United States
facility: St. John Macomb Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Clinic - River Campus
state: Minnesota
city: Saint Cloud
country: United States
facility: Coborn Cancer Center
state: Minnesota
city: Sartell
country: United States
facility: Adult and Pediatric Urology, PLLP
state: Minnesota
city: Kansas City
country: United States
facility: Truman Medical Center - Hospital Hill
state: Missouri
city: Kansas City
country: United States
facility: Veterans Affairs Medical Center - Kansas City
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Cancer Centers - South
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Cancer Centers - North
state: Missouri
city: Lee's Summit
country: United States
facility: Kansas City Cancer Centers - East
state: Missouri
city: Saint Louis
country: United States
facility: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
state: Missouri
city: Billings
country: United States
facility: CCOP - Montana Cancer Consortium
state: Montana
city: Billings
country: United States
facility: St. Vincent Healthcare Cancer Care Services
state: Montana
city: Billings
country: United States
facility: Hematology-Oncology Centers of the Northern Rockies - Billings
state: Montana
city: Billings
country: United States
facility: Billings Clinic - Downtown
state: Montana
city: Bozeman
country: United States
facility: Bozeman Deaconess Cancer Center
state: Montana
city: Butte
country: United States
facility: St. James Healthcare Cancer Care
state: Montana
city: Great Falls
country: United States
facility: Benefis Sletten Cancer Institute
state: Montana
city: Great Falls
country: United States
facility: Great Falls Clinic - Main Facility
state: Montana
city: Helena
country: United States
facility: St. Peter's Hospital
state: Montana
city: Kalispell
country: United States
facility: Kalispell Regional Medical Center
state: Montana
city: Missoula
country: United States
facility: Montana Cancer Specialists at Montana Cancer Center
state: Montana
city: Missoula
country: United States
facility: Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
state: Montana
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Las Vegas
country: United States
facility: CCOP - Nevada Cancer Research Foundation
state: Nevada
city: Manchester
country: United States
facility: Elliot Regional Cancer Center at Elliot Hospital
state: New Hampshire
city: Nashua
country: United States
facility: Foundation Medical Partners
state: New Hampshire
city: Denville
country: United States
facility: Saint Clare's Hospital
state: New Jersey
city: Englewood
country: United States
facility: Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
state: New Jersey
city: Somerville
country: United States
facility: Somerset Medical Center
state: New Jersey
city: Voorhees
country: United States
facility: Cancer Institute of New Jersey at Cooper - Voorhees
state: New Jersey
city: Buffalo
country: United States
facility: Veterans Affairs Medical Center - Buffalo
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Lake Success
country: United States
facility: Monter Cancer Center of the North Shore-LIJ Health System
state: New York
city: Manhasset
country: United States
facility: CCOP - North Shore University Hospital
state: New York
city: Manhasset
country: United States
facility: Don Monti Comprehensive Cancer Center at North Shore University Hospital
state: New York
city: Mount Kisco
country: United States
facility: Mount Kisco Medical Group, PC
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: New York Weill Cornell Cancer Center at Cornell University
state: New York
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center at University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
state: North Carolina
city: Hendersonville
country: United States
facility: Pardee Memorial Hospital
state: North Carolina
city: High Point
country: United States
facility: High Point Regional Hospital
state: North Carolina
city: Akron
country: United States
facility: McDowell Cancer Center at Akron General Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Cancer Institute
state: Oklahoma
city: Coos Bay
country: United States
facility: Bay Area Hospital
state: Oregon
city: Allentown
country: United States
facility: Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
state: Pennsylvania
city: Phoenixville
country: United States
facility: Cancer Center at Phoenixville Hospital
state: Pennsylvania
city: San Antonio
country: United States
facility: Veterans Affairs Medical Center - San Antonio (Murphy)
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center
state: Texas
city: San Antonio
country: United States
facility: University Hospital - San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at University of Utah
state: Utah
city: Auburn
country: United States
facility: Auburn Regional Center for Cancer Care
state: Washington
city: Bellevue
country: United States
facility: Overlake Cancer Center at Overlake Hospital Medical Center
state: Washington
city: Centralia
country: United States
facility: Providence Centralia Hospital
state: Washington
city: Everett
country: United States
facility: Providence Regional Cancer Partnership
state: Washington
city: Federal Way
country: United States
facility: St. Francis Hospital
state: Washington
city: Kirkland
country: United States
facility: Cascade Cancer Center at Evergreen Hospital Medical Center
state: Washington
city: Kirkland
country: United States
facility: Seattle Cancer Care Alliance at EvergreenHealth
state: Washington
city: Olympia
country: United States
facility: Providence St. Peter Hospital Regional Cancer Center
state: Washington
city: Puyallup
country: United States
facility: Good Samaritan Cancer Center
state: Washington
city: Seattle
country: United States
facility: CCOP - Virginia Mason Research Center
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Pacific Medical Center
state: Washington
city: Tacoma
country: United States
facility: Franciscan Cancer Center at St. Joseph Medical Center
state: Washington
city: Tacoma
country: United States
facility: Allenmore Hospital
state: Washington
city: Tacoma
country: United States
facility: CCOP - Northwest
state: Washington
city: Tacoma
country: United States
facility: MultiCare Regional Cancer Center at Tacoma General Hospital
state: Washington
city: Tacoma
country: United States
facility: Madigan Army Medical Center - Tacoma
state: Washington
city: Tacoma
country: United States
facility: St. Clare Hospital
state: Washington
city: La Crosse
country: United States
facility: Gundersen Lutheran Center for Cancer and Blood
state: Wisconsin
city: Mukwonago
country: United States
facility: D.N. Greenwald Center
state: Wisconsin
city: Oconomowoc
country: United States
facility: Regional Cancer Center at Oconomowoc Memorial Hospital
state: Wisconsin
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital Regional Cancer Center
state: Wisconsin
city: Casper
country: United States
facility: Rocky Mountain Oncology
state: Wyoming
city: Sheridan
country: United States
facility: Welch Cancer Center at Sheridan Memorial Hospital
state: Wyoming
Study officials:
affiliation: University of California, San Diego
name: J. Kellogg Parsons, MD, MHS
role: STUDY_CHAIR
References:
citation: Parsons JK, Zahrieh D, Mohler JL, Paskett E, Hansel DE, Kibel AS, Liu H, Seisler DK, Natarajan L, White M, Hahn O, Taylor J, Hartman SJ, Stroup SP, Van Veldhuizen P, Hall L, Small EJ, Morris MJ, Pierce JP, Marshall J. Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial. JAMA. 2020 Jan 14;323(2):140-148. doi: 10.1001/jama.2019.20207.