Trial record 1 of 1 for:    CALGB 70807
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Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01238172
First received: November 9, 2010
Last updated: November 12, 2013
Last verified: November 2013
  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
Behavioral: telephone-based intervention
Other: counseling intervention
Other: educational intervention
Procedure: therapeutic dietary intervention

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:
  • 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) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression defined by PSADT and 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 ]
  • Comparison of quality of life (anxiety and depression, prostate cancer symptom checklist) between the two arms [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Diet as evaluated by three separate 24-hour dietary recalls at baseline and at 12 and 24 months [ 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 I
Patients receive the MEAL program intervention with dietary education and telephone counseling sessions of 24 months; the "Participant Notebook", which provides written material describing the counseling program, dietary targets, offers supporting information on strategies to achieve these targets, supplies referent tools to help patients accurately estimate servings of target foods, and recipes and articles about diet and prostate cancer. 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 and include information on diet and cancer, the challenges of diet change, the advances in prostate cancer control, and new recipes.
Behavioral: telephone-based intervention
Patients undergo telephone counseling
Other: counseling intervention
Patients undergo telephone counseling
Other: educational intervention
Patients receive detailed or general newsletters
Procedure: therapeutic dietary intervention
Patients receive dietary education
Active Comparator: 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.
Other: educational intervention
Patients receive detailed or general newsletters

Detailed Description:

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 (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 recipes.
  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  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 Recruiting
Fairbanks, Alaska, United States, 99701
Contact: Craig R. Nichols, MD    503-494-6346      
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
United States, California
Kaiser Permanente Medical Center - Bellflower Recruiting
Bellflower, California, United States, 90706
Contact: Han A. Koh    562-461-3000      
California Cancer Care, Incorporated - Greenbrae Recruiting
Greenbrae, California, United States, 94904
Contact: Peter D. Eisenberg, MD    415-925-5000      
Rebecca and John Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92093-0658
Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer    858-822-5354    cancercto@ucsd.edu   
Loma Linda University Cancer Institute at Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Clinical Trials Office - Loma Linda University Cancer Institut    909-558-3375      
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Hyung L. Kim    310-423-3277      
Kaiser Permanente Medical Center - Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Han A. Koh    323-667-4011      
Saint Helena Hospital Recruiting
Saint Helena, California, United States, 94574
Contact: David J. Tate    707-963-3611      
Naval Medical Center - San Diego Recruiting
San Diego, California, United States, 92134
Contact: Sean P. Stroup    619-532-7303      
Veterans Affairs Medical Center - San Diego Recruiting
San Diego, California, United States, 92161
Contact: John K. Parsons    858-552-8585 ext 5483      
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego Recruiting
San Diego, California, United States, 92120
Contact: Han A. Koh    619-528-5000      
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi    877-827-3222      
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical Trials Office - University of Colorado Cancer Center    720-848-0650      
Front Range Cancer Specialists Recruiting
Fort Collins, Colorado, United States, 80528
Contact: Diana C. Medgyesy, MD    970-212-7600      
Poudre Valley Hospital Recruiting
Fort Collins, Colorado, United States, 80524
Contact: Clinical Trials Office - Poudre Valley Hospital    970-495-8226      
United States, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Philip J. Stella, MD    734-712-1000      
Middlesex Hospital Cancer Center Recruiting
Middletown, Connecticut, United States, 06457
Contact: Susanna Hong    860-358-2050      
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Clinical Trials Office - Tunnell Cancer Center    302-645-3171      
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services    302-623-4450      
United States, Florida
Lakeland Regional Cancer Center at Lakeland Regional Medical Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Gameel B. Hodge, Jr.    863-603-6565      
Florida Hospital Cancer Institute at Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803-1273
Contact: Clinical Trials Office - Florida Hospital Cancer Institute    407-303-5623      
Cleveland Clinic Florida - Weston Recruiting
Weston, Florida, United States, 33331
Contact: Clinical Trials Office - Cleveland Clinic Florida - Weston    954-659-5705      
United States, Hawaii
Kapiolani Medical Center at Pali Momi Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Oncare Hawaii, Incorporated - Pali Momi Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Cancer Research Center of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Clinical Trials Office - Cancer Research Center of Hawaii    808-586-2979      
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
OnCare Hawaii, Incorporated - Kuakini Recruiting
Honolulu, Hawaii, United States, 96817-3169
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
OnCare Hawaii, Incorporated - Lusitana Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Queen's Cancer Institute at Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Straub Clinic and Hospital, Incorporated Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Castle Medical Center Recruiting
Kailua, Hawaii, United States, 96734
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Kauai Medical Clinic Recruiting
Lihue, Hawaii, United States, 96766
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Clinical Trials Office - Saint Alphonsus Cancer Care Center    208-367-7954      
St. Joseph Regional Medical Center Recruiting
Lewiston, Idaho, United States, 83501
Contact: Yoshio Inoue    208-743-2511      
Idaho Urologic Institute, PA Recruiting
Meridian, Idaho, United States, 83642
Contact: Philip J. Stella, MD    734-712-1000      
United States, Illinois
Louis A. Weiss Memorial Hospital Recruiting
Chicago, Illinois, United States, 60640
Contact: Clinical Trials Office - Louis A. Weiss Memorial Hospital    773-564-5044      
Resurrection Medical Center Recruiting
Chicago, Illinois, United States, 60631
Contact: James P. Brown    773-792-5116      
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research    773-834-7424      
Veterans Affairs Medical Center - Hines Recruiting
Hines, Illinois, United States, 60141
Contact: Nirmala Bhoopalam, MD    708-202-2782      
La Grange Memorial Hospital Recruiting
La Grange, Illinois, United States, 60525
Contact: Clinical Trials Office - La Grange Memorial Hospital    630-856-7526      
West Suburban Center for Cancer Care Recruiting
River Forest, Illinois, United States, 60305
Contact: Isoken Koko    708-763-2700      
United States, Indiana
Bloomington Hospital Regional Cancer Institute Recruiting
Bloomington, Indiana, United States, 47403
Contact: David Y. Lee, MD    812-353-2800      
Elkhart Clinic, LLC Recruiting
Elkhart, Indiana, United States, 46514-2098
Contact: Rafat H. Ansari, MD, FACP    574-234-5123      
Elkhart General Hospital Recruiting
Elkhart, Indiana, United States, 46515
Contact: Rafat H. Ansari, MD, FACP    574-234-5123      
Michiana Hematology-Oncology, PC - Elkhart Recruiting
Elkhart, Indiana, United States, 46514
Contact: Rafat H. Ansari, MD, FACP    574-234-5123      
Howard Community Hospital Recruiting
Kokomo, Indiana, United States, 46904
Contact: Rafat H. Ansari, MD, FACP    574-234-5123      
Center for Cancer Therapy at LaPorte Hospital and Health Services Recruiting
La Porte, Indiana, United States, 46350
Contact: Rafat H. Ansari, MD, FACP    574-234-5123      
Michiana Hematology-Oncology, PC - South Bend Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Rafat H. Ansari, MD, FACP    574-234-5123      
Saint Joseph Regional Medical Center Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Rafat H. Ansari, MD, FACP    574-234-5123      
Michiana Hematology Oncology PC - Plymouth Recruiting
Plymouth, Indiana, United States, 46563
Contact: Rafat H. Ansari, MD, FACP    574-234-5123      
CCOP - Northern Indiana CR Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: Rafat H. Ansari, MD, FACP    574-234-5123      
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Clinical Trials Office - Memorial Hospital of South Bend    800-284-7370      
Michiana Hematology Oncology PC - La Porte Recruiting
Westville, Indiana, United States, 46391
Contact: Rafat H. Ansari, MD, FACP    574-234-5123      
United States, Iowa
McFarland Clinic, PC Recruiting
Ames, Iowa, United States, 50010
Contact: Clinical Trials Office - McFarland Clinic, PC    515-239-2621      
Wendt Regional Cancer Center at Finley Hospital Recruiting
Dubuque, Iowa, United States, 52001
Contact: Nagendra (Bobby) S. Koneru    563-589-2468      
Holden Comprehensive Cancer Center at University of Iowa Recruiting
Iowa City, Iowa, United States, 52242-1002
Contact: Cancer Information Service    800-237-1225      
Mercy Medical Center - Sioux City Recruiting
Sioux City, Iowa, United States, 51102
Contact: Donald B. Wender, MD, PhD    712-252-0088      
Siouxland Hematology-Oncology Associates, LLP Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender, MD, PhD    712-252-0088      
St. Luke's Regional Medical Center Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender, MD, PhD    712-252-0088      
United States, Kansas
St. Rose Ambulatory and Surgery Center Recruiting
Great Bend, Kansas, United States, 67530
Contact: Peter J. VanVeldhuizen, MD    816-861-4700 ext 56775      
Hays Medical Center Recruiting
Hays, Kansas, United States, 67601
Contact: Peter J. VanVeldhuizen, MD    816-861-4700 ext 56775      
Hutchinson Hospital Corporation Recruiting
Hutchinson, Kansas, United States, 67502
Contact: Peter J. VanVeldhuizen, MD    816-861-4700 ext 56775      
Kansas City Cancer Centers - West Recruiting
Kansas City, Kansas, United States, 66112
Contact: Peter J. VanVeldhuizen, MD    816-861-4700 ext 56775      
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160-7357
Contact: Clinical Trials Office - Kansas Masonic Cancer Research Instit    913-588-4709      
Kansas City Cancer Centers - Southwest Recruiting
Overland Park, Kansas, United States, 66210
Contact: Peter J. VanVeldhuizen, MD    816-861-4700 ext 56775      
Mount Carmel Regional Cancer Center Recruiting
Pittsburg, Kansas, United States, 66762
Contact: Peter J. VanVeldhuizen, MD    816-861-4700 ext 56775      
Tammy Walker Cancer Center at Salina Regional Health Center Recruiting
Salina, Kansas, United States, 67401
Contact: Peter J. VanVeldhuizen, MD    816-861-4700 ext 56775      
Kansas City Cancer Center - Shawnee Mission Recruiting
Shawnee Mission, Kansas, United States, 66204
Contact: Peter J. VanVeldhuizen, MD    816-861-4700 ext 56775      
St. Francis Comprehensive Cancer Center Recruiting
Topeka, Kansas, United States, 66606
Contact: Peter J. VanVeldhuizen, MD    816-861-4700 ext 56775      
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of    859-257-3379      
United States, Louisiana
Mary Bird Perkins Cancer Center - Baton Rouge Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Robert W. Veith    225-767-0847      
MBCCOP - LSU Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Robert W. Veith    504-568-5151      
Medical Center of Louisiana - New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Robert W. Veith    504-903-2311      
United States, Maine
Maine Medical Center - Bramhall Campus Recruiting
Portland, Maine, United States, 04102
Contact: Clinical Trials Office - Maine Medical Center - Bramhall Camp    207-885-7565      
Maine Center for Cancer Medicine and Blood Disorders - Scarborough Recruiting
Scarborough, Maine, United States, 04074
Contact: Matthew H. Hayn    207-885-7600      
York Hospital's Oncology Treatment Center Recruiting
York, Maine, United States, 03909
Contact: John P. Mongan    207-351-3777      
United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: David C. Van Echo    301-295-5706      
Union Hospital of Cecil County Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Stephen S. Grubbs, MD    302-366-1200      
United States, Michigan
CCOP - Michigan Cancer Research Consortium Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip J. Stella, MD    734-712-1000      
Saint Joseph Mercy Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Philip J. Stella, MD    734-712-1000      
Battle Creek Health System Cancer Care Center Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Gilbert D.A. Padula    616-966-8000      
Mecosta County Medical Center Recruiting
Big Rapids, Michigan, United States, 49307
Contact: Gilbert D.A. Padula    231-796-8691      
Oakwood Cancer Center at Oakwood Hospital and Medical Center Recruiting
Dearborn, Michigan, United States, 48123-2500
Contact: Clinical Trials Office - Oakwood Cancer Center at Oakwood Hosp    313-593-8090      
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Genesys Hurley Cancer Institute    810-762-8057      
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center    810-762-8057      
Genesys Regional Medical Center Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Philip J. Stella, MD    734-712-1000      
Butterworth Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D.A. Padula    616-391-2799      
CCOP - Grand Rapids Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D.A. Padula    616-391-1230      
Lacks Cancer Center at Saint Mary's Health Care Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D.A. Padula    616-752-5222      
Van Elslander Cancer Center at St. John Hospital and Medical Center Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo    313-343-3166      
Foote Memorial Hospital Recruiting
Jackson, Michigan, United States, 49201
Contact: Philip J. Stella, MD    734-712-1000      
Sparrow Regional Cancer Center Recruiting
Lansing, Michigan, United States, 48912-1811
Contact: Clinical Trials Office - Sparrow Regional Cancer Center    517-364-2890      
St. Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip J. Stella, MD    734-712-1000      
Mercy General Health Partners Recruiting
Muskegon, Michigan, United States, 49444
Contact: Gilbert D.A. Padula    231-672-2000      
St. Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341-2985
Contact: Philip J. Stella, MD    734-712-1000      
Mercy Regional Cancer Center at Mercy Hospital Recruiting
Port Huron, Michigan, United States, 48060
Contact: Philip J. Stella, MD    734-712-1000      
Spectrum Health Reed City Hospital Recruiting
Reed City, Michigan, United States, 49677
Contact: Gilbert D.A. Padula    231-832-3271      
William Beaumont Hospital - Royal Oak Campus Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Clinical Trials Office - William Beaumont Hospital - Royal Oak    248-551-7695      
Seton Cancer Institute at Saint Mary's - Saginaw Recruiting
Saginaw, Michigan, United States, 48601
Contact: Clinical Trials Office - Seton Cancer Institute - Saginaw    989-776-8411      
Lakeland Regional Cancer Care Center - St. Joseph Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Rafat H. Ansari, MD, FACP    574-234-5123      
Lakeside Cancer Specialists, PLLC Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Rafat H. Ansari, MD, FACP    574-234-5123      
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Gilbert D.A. Padula    231-935-6202      
St. John Macomb Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Philip J. Stella, MD    734-712-1000      
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
CentraCare Clinic - River Campus Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Donald J. Jurgens    320-252-5131      
Coborn Cancer Center Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Donald J. Jurgens    320-229-4907      
Adult and Pediatric Urology, PLLP Recruiting
Sartell, Minnesota, United States, 56377
Contact: Donald J. Jurgens    320-259-1411      
United States, Missouri
Kansas City Cancer Centers - North Recruiting
Kansas City, Missouri, United States, 64154
Contact: Peter J. VanVeldhuizen, MD    816-861-4700 ext 56775      
Kansas City Cancer Centers - South Recruiting
Kansas City, Missouri, United States, 64131
Contact: Peter J. VanVeldhuizen, MD    816-861-4700 ext 56775      
Truman Medical Center - Hospital Hill Recruiting
Kansas City, Missouri, United States, 64108
Contact: Peter J. VanVeldhuizen, MD    816-861-4700 ext 56775      
Veterans Affairs Medical Center - Kansas City Recruiting
Kansas City, Missouri, United States, 64128
Contact: Peter J. VanVeldhuizen, MD    816-861-4700 ext 56775      
Kansas City Cancer Centers - East Recruiting
Lee's Summit, Missouri, United States, 64064
Contact: Peter J. VanVeldhuizen, MD    816-861-4700 ext 56775      
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Seth A. Strope    314-747-7222      
United States, Montana
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown    800-996-2663    research@billingsclinic.org   
CCOP - Montana Cancer Consortium Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD    406-238-6290      
Hematology-Oncology Centers of the Northern Rockies - Billings Recruiting
Billings, Montana, United States, 59102
Contact: Benjamin T. Marchello, MD    406-238-6290      
St. Vincent Healthcare Cancer Care Services Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD    406-238-6290      
Bozeman Deaconess Cancer Center Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello, MD    406-238-6290      
St. James Healthcare Cancer Care Recruiting
Butte, Montana, United States, 59701
Contact: Benjamin T. Marchello, MD    406-238-6290      
Benefis Sletten Cancer Institute Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD    406-238-6290      
Great Falls Clinic - Main Facility Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD    406-238-6290      
St. Peter's Hospital Recruiting
Helena, Montana, United States, 59601
Contact: Benjamin T. Marchello, MD    406-238-6290      
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD    406-238-6290      
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Recruiting
Missoula, Montana, United States, 59807
Contact: Clinical Trials Office - Montana Cancer Center at St. Patrick    406-329-7029      
Montana Cancer Specialists at Montana Cancer Center Recruiting
Missoula, Montana, United States, 59807-7877
Contact: Clinical Trials Office - Montana Cancer Specialists at Montana    406-238-6962      
United States, Nevada
CCOP - Nevada Cancer Research Foundation Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton, MD, CM    702-384-0013      
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: John A. Ellerton, MD, CM    702-384-0013      
United States, New Hampshire
Elliot Regional Cancer Center at Elliot Hospital Recruiting
Manchester, New Hampshire, United States, 03103
Contact: Brian R. Knab    603-663-4201      
Foundation Medical Partners Recruiting
Nashua, New Hampshire, United States, 03060
Contact: Roger R. Hakimian    603-886-7900      
United States, New Jersey
Saint Clare's Hospital Recruiting
Denville, New Jersey, United States, 07834
Contact: Donald F. Cann    973-983-2233      
Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Contact: Clinical Trials Office - Dizzy Gillespie Cancer Institute at E    201-894-3456      
Somerset Medical Center Recruiting
Somerville, New Jersey, United States, 08876
Contact: Clinical Trials Office - Somerset Medical Center    908-685-2481      
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo    856-325-6757      
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Clinical Trials Office - Roswell Park Cancer Institute    877-275-7724      
Veterans Affairs Medical Center - Buffalo Recruiting
Buffalo, New York, United States, 14215
Contact: Lynn M. Steinbrenner, MD    716-862-3191      
Monter Cancer Center of the North Shore-LIJ Health System Recruiting
Lake Success, New York, United States, 11042
Contact: Manish A Vira    516-734-8959      
CCOP - North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Manish A Vira    516-734-8954      
Don Monti Comprehensive Cancer Center at North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Clinical Trials Office - Don Monti Comprehensive Cancer Center    516-734-8900      
Mount Kisco Medical Group, PC Recruiting
Mount Kisco, New York, United States, 10549-3417
Contact: Jonathan S. Goldberg    914-241-1050      
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Manish A Vira    718-470-7000      
New York Weill Cornell Cancer Center at Cornell University Recruiting
New York, New York, United States, 10021
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center    212-746-1848      
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Jonathan W. Friedberg    585-275-5345      
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente    877-668-0683      
Pardee Memorial Hospital Recruiting
Hendersonville, North Carolina, United States, 28791
Contact: James E. Radford, MD    828-692-8045      
High Point Regional Hospital Recruiting
High Point, North Carolina, United States, 27261
Contact: Clinical Trials Office - High Point Regional Hospital    336-878-6107      
United States, Ohio
McDowell Cancer Center at Akron General Medical Center Recruiting
Akron, Ohio, United States, 44307
Contact: Esther H. Rehmus, MD    330-344-6505      
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Carla Kurkjian    405-271-6822      
United States, Oregon
Bay Area Hospital Recruiting
Coos Bay, Oregon, United States, 97420
Contact: Bret A. Cook, MD    541-267-5151      
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Recruiting
Allentown, Pennsylvania, United States, 18105
Contact: Eliot L. Friedman, MD    610-402-0512      
Cancer Center at Phoenixville Hospital Recruiting
Phoenixville, Pennsylvania, United States, 19460
Contact: Carl W. Sharer, DO    610-983-1800      
United States, Texas
Cancer Therapy and Research Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Clinical Trials Office - Cancer Therapy and Research Center    210-616-5798      
University Hospital - San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Joseph W. Basler    210-358-4000      
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Joseph W. Basler    210-567-4777      
Veterans Affairs Medical Center - San Antonio (Murphy) Recruiting
San Antonio, Texas, United States, 78209
Contact: Joseph W. Basler    210-617-5300      
United States, Utah
Huntsman Cancer Institute at University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Clinical Trials Office - Huntsman Cancer Institute at Universi    801-581-4477    clinical.trials@hci.utah.edu   
United States, Washington
Auburn Regional Center for Cancer Care Recruiting
Auburn, Washington, United States, 98002
Contact: Yoshio Inoue    253-333-2737      
Overlake Cancer Center at Overlake Hospital Medical Center Recruiting
Bellevue, Washington, United States, 98004
Contact: Yoshio Inoue    425-454-2148      
Providence Centralia Hospital Recruiting
Centralia, Washington, United States, 98531-9027
Contact: Clinical Trials Office - Providence Centralia H    360-493-4300      
Providence Regional Cancer Partnership Recruiting
Everett, Washington, United States, 98201
Contact: Yoshio Inoue    425-297-5500      
St. Francis Hospital Recruiting
Federal Way, Washington, United States, 98003
Contact: Yoshio Inoue    253-944-7997      
Cascade Cancer Center at Evergreen Hospital Medical Center Recruiting
Kirkland, Washington, United States, 98033
Contact: Craig R. Nichols, MD    503-494-6346      
Seattle Cancer Care Alliance at EvergreenHealth Recruiting
Kirkland, Washington, United States, 98034
Contact: Craig R. Nichols, MD    503-494-6346      
Providence St. Peter Hospital Regional Cancer Center Recruiting
Olympia, Washington, United States, 98506-5166
Contact: Yoshio Inoue    360-493-7514      
Good Samaritan Cancer Center Recruiting
Puyallup, Washington, United States, 98372
Contact: Yoshio Inoue    253-697-4000      
CCOP - Virginia Mason Research Center Recruiting
Seattle, Washington, United States, 98101
Contact: Craig R. Nichols, MD    503-494-6346      
Pacific Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Craig R. Nichols, MD    503-494-6346      
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Craig R. Nichols, MD    503-494-6346      
Allenmore Hospital Recruiting
Tacoma, Washington, United States, 98405
Contact: Yoshio Inoue    253-459-6446      
CCOP - Northwest Recruiting
Tacoma, Washington, United States, 98405
Contact: Yoshio Inoue    253-403-1461      
Franciscan Cancer Center at St. Joseph Medical Center Recruiting
Tacoma, Washington, United States, 98405-3004
Contact: Clinical Trials Office - Franciscan Cancer Center    253-426-6914      
Madigan Army Medical Center - Tacoma Recruiting
Tacoma, Washington, United States, 98431
Contact: Timothy C. Brand    206-968-1110      
MultiCare Regional Cancer Center at Tacoma General Hospital Recruiting
Tacoma, Washington, United States, 98405
Contact: Clinical Trials Office - MultiCare Regional Cancer Center    253-403-3229      
St. Clare Hospital Recruiting
Tacoma, Washington, United States, 98499
Contact: Yoshio Inoue    253-588-1711      
United States, Wisconsin
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center    608-775-2385    cancerctr@gundluth.org   
D.N. Greenwald Center Recruiting
Mukwonago, Wisconsin, United States, 53149
Contact: Michael A. Thompson    262-363-1916      
Regional Cancer Center at Oconomowoc Memorial Hospital Recruiting
Oconomowoc, Wisconsin, United States, 53066
Contact: Clinical Trials Office - Regional Cancer Center at Oconomowoc    262-928-7878      
Waukesha Memorial Hospital Regional Cancer Center Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Clinical Trials Office - Waukesha Memorial Hospital Regional C    262-928-7632      
United States, Wyoming
Rocky Mountain Oncology Recruiting
Casper, Wyoming, United States, 82609
Contact: Benjamin T. Marchello, MD    406-238-6290      
Welch Cancer Center at Sheridan Memorial Hospital Recruiting
Sheridan, Wyoming, United States, 82801
Contact: Benjamin T. Marchello, MD    406-238-6290      
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: J. Kellogg Parsons, MD, MHS University of California, San Diego
Study Chair: James Marshall, PhD Roswell Park Cancer Institute
  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: CDR0000687958, CALGB-70807
Study First Received: November 9, 2010
Last Updated: November 12, 2013
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:
Prostatic Neoplasms
Disease Progression
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014