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Sponsors and Collaborators: |
American College of Surgeons National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00023686 |
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery is more effective than internal radiation in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with that of internal radiation in treating patients who have stage II prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Procedure: conventional surgery Radiation: brachytherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Trial of Radical Prostatectomy Versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer |
Study Start Date: | October 2001 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
PROJECTED ACCRUAL: A total of 1,980 patients (990 per treatment arm) will be accrued for this study within 5.5 years.
Ages Eligible for Study: | up to 75 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate within the past 120 days
Prostate-specific antigen (PSA) no greater than 10 ng/mL
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
At least 90 days since prior NHT
Radiotherapy:
Surgery:
No prior surgery for prostate cancer or benign disease, including:
United States, Arkansas | |
St. Vincent Cancer Center | |
Little Rock, Arkansas, United States, 72205-5499 | |
United States, California | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94143-0128 | |
United States, District of Columbia | |
Walter Reed Army Medical Center | |
Washington, District of Columbia, United States, 20307-5000 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | |
Tampa, Florida, United States, 33612-9497 | |
United States, Georgia | |
Winship Cancer Institute of Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Southern Illinois University School of Medicine | |
Springfield, Illinois, United States, 62794-9230 | |
United States, Iowa | |
Holden Comprehensive Cancer Center at University of Iowa | |
Iowa City, Iowa, United States, 52242-1062 | |
United States, Kansas | |
Kansas Cancer Institute at the University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160-7357 | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63110 | |
United States, New Mexico | |
Northeast Heights Cancer Center | |
Albuquerque, New Mexico, United States, 87109 | |
United States, New York | |
James P. Wilmot Cancer Center at University of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
Comprehensive Cancer Center at Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157-1082 | |
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Wellspan Health - York Cancer Center | |
York, Pennsylvania, United States, 17403 | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | |
Nashville, Tennessee, United States, 37232-6838 | |
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030-4009 | |
Wilford Hall Medical Center | |
Lackland Air Force Base, Texas, United States, 78236-5300 | |
United States, Utah | |
American Fork Hospital | |
American Fork, Utah, United States, 84003 | |
Dixie Regional Medical Center | |
Saint George, Utah, United States, 84770 | |
LDS Hospital | |
Salt Lake City, Utah, United States, 84143 | |
McKay-Dee Hospital Center | |
Ogden, Utah, United States, 84403 | |
Utah Valley Regional Medical Center - Provo | |
Provo, Utah, United States, 84604 | |
United States, Vermont | |
Fletcher Allen Health Care - Medical Center Campus | |
Burlington, Vermont, United States, 05401 | |
United States, Virginia | |
Sentara Norfolk General Hospital | |
Norfolk, Virginia, United States, 23507 | |
Veterans Affairs Medical Center - Richmond | |
Richmond, Virginia, United States, 23249 | |
United States, Washington | |
Madigan Army Medical Center | |
Tacoma, Washington, United States, 98431-5048 | |
University Cancer Center at University of Washington Medical Center | |
Seattle, Washington, United States, 98195-6043 | |
Veterans Affairs Medical Center - Seattle | |
Seattle, Washington, United States, 98108 | |
Canada, British Columbia | |
Vancouver General Hospital | |
Vancouver, British Columbia, Canada, V5Z 355 | |
Canada, Ontario | |
Cancer Care Ontario-London Regional Cancer Centre | |
London, Ontario, Canada, N6A 4L6 | |
Margaret and Charles Juravinski Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Toronto Sunnybrook Regional Cancer Centre | |
Toronto, Ontario, Canada, M4N 3M5 | |
Canada, Quebec | |
Centre Hospitalier Universitaire de Quebec | |
Quebec City, Quebec, Canada, G1R 2J6 |
Study Chair: | Paul H. Lange, MD | University of Washington |
Study ID Numbers: | CDR0000068851, ACOSOG-Z0070 |
Study First Received: | September 13, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00023686 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage II prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |