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Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: July 8, 2003   Last Updated: November 21, 2009   History of Changes
Sponsor: Radiation Therapy Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00063882
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer.


Condition Intervention Phase
Prostate Cancer
 Radiation: iodine I 125
Radiation: palladium Pd 103
Radiation: radiation therapy
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone for Selected Patients With Intermediate Risk Prostatic Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Iodine
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Freedom from progression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical (i.e., prostate-specific antigen) failure for at least 5 years [ Designated as safety issue: No ]
  • Biochemical failure by the Phoenix definition [ Designated as safety issue: No ]
  • Disease-specific survival [ Designated as safety issue: No ]
  • Local progression [ Designated as safety issue: No ]
  • Distant metastases [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Incidence of "acute" toxicities [ Designated as safety issue: Yes ]
  • Time to "late" 3+ toxicities [ Designated as safety issue: Yes ]
  • Health-related quality of life as measured by EPIC, EQ5D, and AUA-SI from baseline to 4 months (early) and then at 2 years (late) after initiation of therapy [ Designated as safety issue: No ]
  • Feasibility of collecting Medicare data in a large RTOG prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and external beam radiotherapy [ Designated as safety issue: No ]

Estimated Enrollment: 586
Study Start Date: June 2003
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
Patients undergo external beam radiotherapy 5 days a week for 5 weeks. Within 2-4 weeks of radiotherapy, patients undergo interstitial brachytherapy with iodine I 125 or palladium Pd 103 seeds.
Radiation: iodine I 125
Given as interstitial seeds
Radiation: palladium Pd 103
Given as interstitial seeds
Radiation: radiation therapy
Given as external beam radiation therapy over 5 weeks
Arm II: Active Comparator
Patients undergo interstitial brachytherapy only, as in arm I.
Radiation: iodine I 125
Given as interstitial seeds
Radiation: palladium Pd 103
Given as interstitial seeds

Detailed Description:

OBJECTIVES:

  • Compare the 5-year freedom from progression in patients with intermediate-risk prostate cancer treated with interstitial brachytherapy with or without external beam radiotherapy (EBRT).
  • Compare biochemical (i.e., prostate-specific antigen) failure, biochemical failure by the Phoenix definition, disease-specific survival, local progression, and distant metastases in patients treated with these regimens.
  • Compare morbidity and quality of life of patients treated with these regimens.
  • Determine the feasibility of collecting Medicare data in a large RTOG prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and EBRT.
  • Prospectively collect diagnostic biopsy samples from these patients for future biomarker analyses.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T1c vs T2a or T2b), Gleason score (≤ 6 vs 7), prostate-specific antigen (< 10 ng/mL vs 10-20 ng/mL), and prior neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo external beam radiotherapy 5 days a week for 5 weeks. Within 2-4 weeks of radiotherapy, patients undergo interstitial brachytherapy with iodine I 125 or palladium Pd 103 seeds.
  • Arm II: Patients undergo interstitial brachytherapy only, as in arm I. Quality of life is assessed at baseline, at 4, 12, and 24 months, and then annually for 3 years.

After completion of study treatment, patients are followed at 3-5 weeks, at 4, 6, 9, and 12 months, every 6 months for 4 years, and then annually thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • T1c-T2b, N0, M0

  • Intermediate-risk disease, as defined by 1 of the following:

    • Gleason score < 7 AND prostate-specific antigen (PSA) 10-20 ng/mL
    • Gleason score 7 AND PSA < 10 ng/mL
  • No evidence of distant metastases
  • Prostate volume ≤ 60 cc by transrectal ultrasonography
  • American Urological Association voiding symptom score no greater than 15 (alpha blockers allowed)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Patients must use effective contraception
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ at any other site
  • No major medical or psychiatric illness that would preclude study therapy
  • No hip prosthesis

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Prior neoadjuvant hormonal therapy allowed provided the following are true:

    • Therapy was initiated within 2-6 months of study enrollment
    • Therapy was no more than 6 months in duration
    • Use of 5-alpha reductase inhibitors (e.g., finasteride) is discontinued before registration
  • No concurrent hormonal therapy

Radiotherapy

  • No prior pelvic radiotherapy

Surgery

  • No prior radical surgery for prostate cancer
  • No prior transurethral resection of the prostate
  • No prior cryosurgery

Other

  • No prior transurethral needle ablation of the prostate
  • No prior transurethral microwave thermotherapy of the prostate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063882

  Hide Study Locations
Locations
United States, Arizona
Arizona Oncology Services Foundation Recruiting
Phoenix, Arizona, United States, 85013
Contact: David G. Brachman, MD, FACRO     602-274-4484        
United States, California
Alta Bates Summit Comprehensive Cancer Center Recruiting
Berkeley, California, United States, 94704
Contact: Clinical Trials Office - Alta Bates Summit Comprehensive Cance     510-204-3428        
Alta Bates Summit Medical Center - Summit Campus Recruiting
Oakland, California, United States, 94609
Contact: Clinical Trials Office - Alta Bates Summit Medical Center - Su     510-204-1414        
Auburn Radiation Oncology Recruiting
Auburn, California, United States, 95603
Contact: Seth A. Rosenthal     916-888-1266        
Bay Area Breast Surgeons, Incorporated Recruiting
Oakland, California, United States, 94609
Contact: James H. Feusner, MD     510-428-3689        
California Cancer Center - Woodward Park Office Recruiting
Fresno, California, United States, 93720
Contact: Brent L. Kane     559-447-4050        
California Pacific Medical Center - California Campus Recruiting
San Francisco, California, United States, 94118
Contact: David H. Irwin, MD     510-204-1591        
CCOP - Bay Area Tumor Institute Recruiting
Oakland, California, United States, 94609
Contact: James H. Feusner, MD     510-428-3689        
Doctors Medical Center - San Pablo Campus Recruiting
San Pablo, California, United States, 94806
Contact: James H. Feusner, MD     510-428-3689        
East Bay Radiation Oncology Center Recruiting
Castro Valley, California, United States, 94546
Contact: James H. Feusner, MD     510-428-3689        
Recruiting
Santa Clara, California, United States, 95051
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Foundation Hospital - San Rafael Recruiting
San Rafael, California, United States, 94903
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente - Division of Research - Oakland Recruiting
Oakland, California, United States, 94611
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Hayward Recruiting
Hayward, California, United States, 94545
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Oakland Recruiting
Oakland, California, United States, 94611
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Rancho Cordova Recruiting
Rancho Cardova, California, United States, 95670
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Redwood City Recruiting
Redwood City, California, United States, 94063
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Richmond Recruiting
Richmond, California, United States, 94801
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Roseville Recruiting
Roseville, California, United States, 95661
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Sacramento Recruiting
Sacramento, California, United States, 95825
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - San Francisco Geary Campus Recruiting
San Francisco, California, United States, 94115
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Santa Clara Kiely Campus Recruiting
Santa Clara, California, United States, 95051
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Santa Rosa Recruiting
Santa Rosa, California, United States, 95403
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Santa Teresa Recruiting
San Jose, California, United States, 95119
Contact: Louis Fehrenbacher, MD     707-651-2577        
Valley Medical Oncology Recruiting
Fremont, California, United States, 94538
Contact: James H. Feusner, MD     510-428-3689        
Kaiser Permanente Medical Center - Walnut Creek Recruiting
Walnut Creek, California, United States, 94596
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Facility - Stockton Recruiting
Stockton, California, United States, 95210
Contact: Louis Fehrenbacher, MD     707-651-2577        
Larry G Strieff MD Medical Corporation Recruiting
Oakland, California, United States, 94609
Contact: James H. Feusner, MD     510-428-3689        
Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center Recruiting
Rancho Mirage, California, United States, 92270
Contact: Paul W. Adams     760-674-3600        
Marin Cancer Institute at Marin General Hospital Recruiting
Greenbrae, California, United States, 94904
Contact: David H. Irwin, MD     510-204-1591        
Mercy Cancer Center at Mercy San Juan Medical Center Recruiting
Carmichael, California, United States, 95608
Contact: Seth A. Rosenthal     916-904-3440        
Mercy General Hospital Recruiting
Sacramento, California, United States, 95819
Contact: Seth A. Rosenthal     916-453-4453        
Peninsula Medical Center Recruiting
Burlingame, California, United States, 94010
Contact: David H. Irwin, MD     510-204-1591        
Providence Saint Joseph Medical Center - Burbank Recruiting
Burbank, California, United States, 91505
Contact: Clinical Trials Office - Providence Saint Joseph Medical Cente     818-847-3220        
Radiation Oncology Center - Roseville Recruiting
Roseville, California, United States, 95661
Contact: Seth A. Rosenthal     916-969-4422        
Radiation Oncology Centers - Cameron Park Recruiting
Cameron Park, California, United States, 95682
Contact: Seth A. Rosenthal     916-622-9700        
Radiological Associates of Sacramento Medical Group, Incorporated Recruiting
Sacramento, California, United States, 95815
Contact: Seth A. Rosenthal     916-646-8300        
Rohnert Park Cancer Center Recruiting
Rohnert Park, California, United States, 94928
Contact: Louis Fehrenbacher, MD     707-651-2577        
Solano Radiation Oncology Center Recruiting
Vacaville, California, United States, 95687
Contact: Seth A. Rosenthal     707-447-0400        
South Sacramento Cancer Center Recruiting
Sacramento, California, United States, 95823
Contact: Louis Fehrenbacher, MD     707-651-2577        
South Sacramento Kaiser-Permanente Medical Center Recruiting
Sacramento, California, United States, 95823
Contact: Louis Fehrenbacher, MD     707-651-2577        
Sutter Health - Western Division Cancer Research Group Recruiting
Greenbrae, California, United States, 94904
Contact: David H. Irwin, MD     510-204-1591        
Sutter Solano Medical Center Recruiting
Vallejo, California, United States, 94589
Contact: David H. Irwin, MD     510-204-1591        
Tom K Lee, Incorporated Recruiting
Oakland, California, United States, 94609
Contact: James H. Feusner, MD     510-428-3689        
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        
Valley Medical Oncology Consultants - Castro Valley Recruiting
Castro Valley, California, United States, 94546
Contact: James H. Feusner, MD     510-428-3689        
Valley Medical Oncology Consultants - Pleasanton Recruiting
Pleasanton, California, United States, 94588
Contact: James H. Feusner, MD     510-428-3689        
Kaiser Permanente Medical Center - South San Francisco Recruiting
South San Francisco, California, United States, 94080
Contact: Louis Fehrenbacher, MD     707-651-2577        
United States, Colorado
Penrose Cancer Center at Penrose Hospital Recruiting
Colorado Springs, Colorado, United States, 80933
Contact: Clinical Trials Office - Penrose Cancer Center     719-776-5275        
St. Mary - Corwin Regional Medical Center Recruiting
Pueblo, Colorado, United States, 81004
Contact: John D. Stageberg     719-557-4000        
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Recruiting
Grand Junction, Colorado, United States, 81502
Contact: Douglas B. Rock, MD     970-244-2442        
United States, Connecticut
Helen and Harry Gray Cancer Center at Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102-5037
Contact: Clinical Trials Office - Helen and Harry Gray Cancer Center     860-545-5363        
Hospital of Saint Raphael Recruiting
New Haven, Connecticut, United States, 06511
Contact: Clinical Trials Office - Hospital of Saint Raphael     203-789-3545        
United States, Delaware
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services     302-733-6227        
United States, Florida
CCOP - Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Michael A. Samuels     305-674-2625        
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Recruiting
Jupiter, Florida, United States, 33458
Contact: Clinical Trials Office - Ella Milbank Foshay Cancer Center     561-745-5768        
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Recruiting
Tampa, Florida, United States, 33612-9497
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese     800-456-7121     canceranswers@moffitt.org    
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Clinical Trials Office - Michael and Dianne Bienes Comprehensi     954-776-3239        
United States, Georgia
Emory Crawford Long Hospital Recruiting
Atlanta, Georgia, United States, 30308
Contact: Peter J. Rossi     404-686-4411        
Georgia Cancer Center for Excellence at Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Peter J. Rossi     404-489-9000        
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: John A. Pablo     912-819-6000        
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Frank G. Lake, MD     770-535-3393        
Winship Cancer Institute of Emory University Recruiting
Altanta, Georgia, United States, 30322
Contact: Peter J. Rossi     404-778-5180        
United States, Illinois
Cancer Institute at St. John's Hospital Recruiting
Springfield, Illinois, United States, 62702
Contact: Bruce E. Shevlin, MD     217-525-5666        
Regional Cancer Center at Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781-0001
Contact: Clinical Trials Office - Regional Cancer Center at Memorial Me     217-788-4233        
Resurrection Medical Center Recruiting
Chicago, Illinois, United States, 60631
Contact: Christopher G. Rose, MD     847-965-3200        
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        
United States, Kansas
Menorah Medical Center Recruiting
Overland Park, Kansas, United States, 66209
Contact: Rakesh Gaur, MD     816-823-0555        
Shawnee Mission Medical Center Recruiting
Shawnee Mission, Kansas, United States, 66204
Contact: Rakesh Gaur, MD     816-823-0555        
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, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit     800-888-8823        
St. Agnes Hospital Cancer Center Recruiting
Baltimore, Maryland, United States, 21229
Contact: Richard S. Hudes, MD     410-368-2965        
United States, Massachusetts
Cape Cod Hospital Recruiting
Hyannis, Massachusetts, United States, 02601
Contact: Daniel J. Canaday     508-771-1800        
MetroWest Medical Center - Framingham Union Hospital Recruiting
Framingham, Massachusetts, United States, 01702
Contact: Lakshmi N. Shanmugham     508-383-1000        
South Suburban Oncology Center Recruiting
Quincy, Massachusetts, United States, 02169
Contact: Harold J. Barthold, MD     617-376-6400        
Winchester Hospital Radiation Oncology Center Recruiting
Winchester, Massachusetts, United States, 01890
Contact: Harold J. Barthold, MD     617-376-6400        
United States, Michigan
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord, MD     269-373-7458        
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center     810-762-8057        
CCOP - Michigan Cancer Research Consortium Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Salam A. Jafar, MD     734-712-3596        
Foote Memorial Hospital Recruiting
Jackson, Michigan, United States, 49201
Contact: Salam A. Jafar, MD     734-712-3596        
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Genesys Hurley Cancer Institute     810-762-8057        
Hickman Cancer Center at Bixby Medical Center Recruiting
Adrian, Michigan, United States, 49221
Contact: Clinical Trials Office - Hickman Cancer Center at Bixby Medica     517-265-0116        
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord, MD     269-373-7458        
Mercy Regional Cancer Center at Mercy Hospital Recruiting
Port Huron, Michigan, United States, 48060
Contact: Salam A. Jafar, MD     734-712-3596        
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        
Saint Joseph Mercy Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Salam A. Jafar, MD     734-712-3596        
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        
Sparrow Regional Cancer Center Recruiting
Lansing, Michigan, United States, 48912-1811
Contact: Clinical Trials Office - Sparrow Regional Cancer Center     517-364-2890        
St. John Macomb Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Salam A. Jafar, MD     734-712-3596        
St. Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Salam A. Jafar, MD     734-712-3596        
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        
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center     269-373-7458        
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Missouri
CCOP - Kansas City Recruiting
Kansas City, Missouri, United States, 64131
Contact: Rakesh Gaur, MD     816-823-0555        
Heartland Regional Medical Center Recruiting
Saint Joseph, Missouri, United States, 64506
Contact: Rakesh Gaur, MD     816-823-0555        
Independence Regional Health Center Recruiting
Independence, Missouri, United States, 64050
Contact: Rakesh Gaur, MD     816-823-0555        
Liberty Hospital Recruiting
Liberty, Missouri, United States, 64068
Contact: Rakesh Gaur, MD     816-823-0555        
North Kansas City Hospital Recruiting
Kansas City, Missouri, United States, 64116
Contact: Rakesh Gaur, MD     816-823-0555        
Parvin Radiation Oncology Recruiting
Kansas City, Missouri, United States, 64116
Contact: Rakesh Gaur, MD     816-823-0555        
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jeff M. Michalski, MD     314-362-8566        
Saint Luke's Cancer Institute at Saint Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Contact: Rakesh Gaur, MD     816-823-0555        
Research Medical Center Recruiting
Kansas City, Missouri, United States, 64132
Contact: Rakesh Gaur, MD     816-823-0555        
St. Joseph Medical Center Recruiting
Kansas City, Missouri, United States, 64114
Contact: Rakesh Gaur, MD     816-823-0555        
Truman Medical Center - Hospital Hill Recruiting
Kansas City, Missouri, United States, 64108
Contact: Rakesh Gaur, MD     816-823-0555        
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital Recruiting
Kearney, Nebraska, United States, 68848-1990
Contact: Clinical Trials Office - Good Samaritan Cancer Center at Good     308-865-7963        
United States, Nevada
CCOP - Nevada Cancer Research Foundation Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton, MD, CM     702-384-0013        
Radiation Oncology Associates - Reno Recruiting
Reno, Nevada, United States, 89509
Contact: Jonathan S. Tay     702-823-1990        
Renown Institute for Cancer at Renown Regional Medical Center Recruiting
Reno, Nevada, United States, 89502
Contact: Lawrence R. Dardick, MD     775-982-5638        
Saint Mary's Regional Medical Center Recruiting
Reno, Nevada, United States, 89503
Contact: Jonathan S. Tay     775-770-3194        
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center     603-650-7609     cancerhelp@dartmouth.edu    
United States, New Jersey
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        
CentraState Medical Center Recruiting
Freehold, New Jersey, United States, 07728
Contact: Edward M. Soffen, MD     609-497-4304        
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Recruiting
Marlton, New Jersey, United States, 08053
Contact: Clinical Trials Office - Fox Chase Virtua Health Cancer Progra     888-847-8823        
Princeton Radiation Oncology Center Recruiting
Jamesburg, New Jersey, United States, 08831
Contact: Douglas A. Fein     609-655-5755        
University Medical Center at Princeton Recruiting
Princeton, New Jersey, United States, 08540-3298
Contact: Douglas A. Fein     609-497-4000        
United States, New Mexico
Lovelace Medical Center - Downtown Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Lisa P. Berle     505-727-8000        
Radiation Oncology Associates, PA Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Lisa P. Berle     505-889-9639        
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-5636
Contact: Clinical Trials Office - University of New Mexico Cancer Cente     505-272-6972        
United States, New York
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital Recruiting
Cooperstown, New York, United States, 13326
Contact: Timothy Campbell     607-547-3336        
Beth Israel Medical Center - Petrie Division Recruiting
New York, New York, United States, 10003-3803
Contact: Clinical Trials Office - Beth Israel Medical Center - Petrie D     212-844-6286        
New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Sameer Rafla-Demetrious, MD, PhD, FRCR, FACR, FRSM     718-780-3677        
Tucker Center for Cancer Care at Orange Regional Medical Center Recruiting
Middletown, New York, United States, 10940-4199
Contact: Clinical Trials Office - Tucker Center for Cancer Care at Oran     845-342-7609        
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28232-2861
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas     704-355-2884        
New Hanover Radiation Oncology, PA Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Michael A. Papagikos     910-251-1839        
Wayne Memorial Hospital, Incorporated Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD     919-580-0000        
Wayne Radiation Oncology Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD     919-580-0000        
United States, Ohio
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 45601
Contact: Clinical Trials Office - Adena Regional Medical Center     877-779-7585        
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service     866-627-7616     osu@emergingmed.com    
Barberton Citizens Hospital Recruiting
Barberton, Ohio, United States, 44203
Contact: William F. Demas, MD     330-375-3557        
Cancer Care Center, Incorporated Recruiting
Salem, Ohio, United States, 44460
Contact: William F. Demas, MD     330-375-3557        
Cancer Treatment Center Recruiting
Wooster, Ohio, United States, 44691
Contact: Clinical Trials Office - Cancer Treatment Center     330-375-4221        
CCOP - Columbus Recruiting
Columbus, Ohio, United States, 43215
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Mount Carmel Health - West Hospital Recruiting
Columbus, Ohio, United States, 43222
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Doctors Hospital at Ohio Health Recruiting
Columbus, Ohio, United States, 43228
Contact: Clinical Trials Office - Doctors Hospital at Ohio Health     614-566-3275        
Flower Hospital Cancer Center Recruiting
Sylvania, Ohio, United States, 43560
Contact: Clinical Trials Office - Flower Hospital Cancer Center     419-824-1842        
Grady Memorial Hospital Recruiting
Delaware, Ohio, United States, 43015
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Grant Medical Center Cancer Care Recruiting
Columbus, Ohio, United States, 43215
Contact: Clinical Trials Office - Grant Medical Center Cancer Care     614-566-4475        
Hematology Oncology Center Recruiting
Elyria, Ohio, United States, 44035
Contact: Paul L. Schaefer, MD     419-479-5605        
Licking Memorial Cancer Care Program at Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Lima Memorial Hospital Recruiting
Lima, Ohio, United States, 45804
Contact: Paul L. Schaefer, MD     419-479-5605        
Medical University of Ohio Cancer Center Recruiting
Toledo, Ohio, United States, 43614
Contact: Clinical Trials Office - Medical University of Ohio Cancer Cen     419-383-6583        
Mercy Hospital of Tiffin Recruiting
Tiffin, Ohio, United States, 44883
Contact: Paul L. Schaefer, MD     419-479-5605        
Mercy Medical Center Recruiting
Springfield, Ohio, United States, 45504
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
CCOP - Toledo Community Hospital Recruiting
Toledo, Ohio, United States, 43617
Contact: Paul L. Schaefer, MD     419-479-5605        
Mount Carmel St. Ann's Cancer Center Recruiting
Westerville, Ohio, United States, 43081
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
North Coast Cancer Care, Incorporated Recruiting
Sandusky, Ohio, United States, 44870
Contact: Paul L. Schaefer, MD     419-479-5605        
Northwest Ohio Oncology Center Recruiting
Maumee, Ohio, United States, 43537-1839
Contact: Paul L. Schaefer, MD     419-479-5605        
Riverside Methodist Hospital Cancer Care Recruiting
Columbus, Ohio, United States, 43214-3998
Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C     614-566-4475        
St. Anne Mercy Hospital Recruiting
Toledo, Ohio, United States, 43623
Contact: Paul L. Schaefer, MD     419-479-5605        
St. Charles Mercy Hospital Recruiting
Oregon, Ohio, United States, 43616
Contact: Paul L. Schaefer, MD     419-479-5605        
Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Clinical Trials Office - Toledo Hospital     419-824-1842        
St. Vincent Mercy Medical Center Recruiting
Toledo, Ohio, United States, 43608
Contact: Paul L. Schaefer, MD     419-479-5605        
Strecker Cancer Center at Marietta Memorial Hospital Recruiting
Marietta, Ohio, United States, 45750
Contact: J. Philip Kuebler, MD, PhD     614-442-3130        
Summa Center for Cancer Care at Akron City Hospital Recruiting
Akron, Ohio, United States, 44309-2090
Contact: Clinical Trials Office - Akron City Hospital     330-375-6101        
Toledo Clinic, Incorporated - Main Clinic Recruiting
Toledo, Ohio, United States, 43623
Contact: Paul L. Schaefer, MD     419-479-5605        
St. Rita's Medical Center Recruiting
Lima, Ohio, United States, 45801
Contact: Clinical Trials Office - St. Rita's Medical Center     419-226-9617        
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Terence S. Herman     405-271-6822        
United States, Pennsylvania
Albert Einstein Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Kenneth L. Zeitzer, MD     215-456-6280        
Fox Chase Cancer Center - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi     215-728-4790        
Frankford Hospital Cancer Center - Torresdale Campus Recruiting
Philadelphia, Pennsylvania, United States, 19114
Contact: Adam P. Dicker, MD, PhD     215-955-6527        
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19107-5541
Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer     215-955-6084        
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Recruiting
Reading, Pennsylvania, United States, 19612-6052
Contact: Clinical Trials Office - McGlinn Family Regional Cancer Center     610-988-9323        
Northeast Radiation Oncology Center Recruiting
Dunmore, Pennsylvania, United States, 18512
Contact: Adam P. Dicker, MD, PhD     215-955-6527        
York Cancer Center at Apple Hill Medical Center Recruiting
York, Pennsylvania, United States, 17405
Contact: Amit B. Shah     717-741-8180        
United States, Texas
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        
United States, Utah
Dixie Regional Medical Center - East Campus Recruiting
Saint George, Utah, United States, 84770
Contact: Clinical Trials Office - Dixie Regional Medical Center - East     435-688-4167        
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: R. Jeffrey Lee, MD     801-408-1146        
LDS Hospital Recruiting
Salt Lake City, Utah, United States, 84143
Contact: R. Jeffrey Lee, MD     801-408-1146        
Sandra L. Maxwell Cancer Center Recruiting
Cedar City, Utah, United States, 84720
Contact: R. Jeffrey Lee, MD     801-408-1146        
Utah Cancer Specialists at UCS Cancer Center Recruiting
Salt Lake City, Utah, United States, 84106
Contact: R. Jeffrey Lee, MD     801-408-1146        
Utah Valley Regional Medical Center - Provo Recruiting
Provo, Utah, United States, 84604
Contact: Clinical Trials Office - Utah Valley Regional Medical Center -     801-357-7965        
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Recruiting
Ogden, Utah, United States, 84403
Contact: Clinical Trials Office - McKay-Dee Hospital Center     801-387-7426        
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus Recruiting
Burlington, Vermont, United States, 05401
Contact: Clinical Trials Office - Fletcher Allen Health Care     802-656-8990        
United States, Virginia
Fredericksburg Oncology, Incorporated Recruiting
Fredericksburg, Virginia, United States, 22401
Contact: Paul L. Schaefer, MD     419-479-5605        
Naval Medical Center - Portsmouth Recruiting
Portsmouth, Virginia, United States, 23708-2197
Contact: Clinical Trials Office - Naval Medical Center - Portsmouth     757-953-5939        
Veterans Affairs Medical Center - Richmond Recruiting
Richmond, Virginia, United States, 23249
Contact: Clinical Trials Office - Veterans Affairs Medical Center - Ric     804-675-5646        
United States, Washington
CCOP - Northwest Recruiting
Tacoma, Washington, United States, 98405
Contact: Lauren K. Colman, MD     253-403-1677        
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        
Good Samaritan Cancer Center Recruiting
Puyallup, Washington, United States, 98372
Contact: Lauren K. Colman, MD     253-403-1677        
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. Francis Hospital Recruiting
Federal Way, Washington, United States, 98003
Contact: Lauren K. Colman, MD     253-403-1677        
United States, Wisconsin
Columbia Saint Mary's Hospital - Ozaukee Recruiting
Mequon, Wisconsin, United States, 53097
Contact: Carl E. Olson, MD     414-291-1556        
Columbia-Saint Mary's Cancer Care Center Recruiting
Milwaukee, Wisconsin, United States, 53211
Contact: Clinical Trials Office - Columbia-St. Mary's Cancer Care Cente     414-326-1739        
Diagnostic and Treatment Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: E. Ann Czyzewski     715-393-3900        
Franciscan Skemp Healthcare - La Crosse Campus Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Kernan J. Minehan, MD     608-791-9510        
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    
Marshfield Clinic - Marshfield Center Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center     800-782-1581 ext. 94457        
Ministry Medical Group at Saint Mary's Hospital Recruiting
Rhinelander, Wisconsin, United States, 54501
Contact: E. Ann Czyzewski     715-361-4700        
University of Wisconcin Cancer Center at Aspirus Wausau Hospital Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Clinical Trials Office - University of Wisconsin Cancer Center     608-262-5223        
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic     414-649-5717        
West Allis Memorial Hospital Recruiting
West Allis, Wisconsin, United States, 53227
Contact: Clinical Trials Office - West Allis Memorial Hospital     414-649-5717        
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Juanita M. Crook     416-946-2811        
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Bradley R. Prestidge, MD Texas Cancer Clinic
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Radiation Therapy Oncology Group ( Walter John Curran, Jr )
Study ID Numbers: CDR0000288823, RTOG-0232, CTSU
Study First Received: July 8, 2003
Last Updated: November 21, 2009
ClinicalTrials.gov Identifier: NCT00063882     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
 Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009



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