Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Procedure: surgeryRadiation: radiation
- Registration Number
- NCT00023686
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* Compare overall survival in patients with stage II prostate cancer treated with radical prostatectomy vs brachytherapy.
* Compare metastasis-free survival and probability of survival without symptoms of patients treated with these regimens.
* Compare the side effects of these treatment regimens in these patients.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
* Arm I: Patients undergo radical prostatectomy.
* Arm II: Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,980 patients (990 per treatment arm) will be accrued for this study within 5.5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 190
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description surgery surgery Patients undergo radical prostatectomy. Patients are followed every 6 months for 5 years and then annually thereafter. radiation radiation Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds. Patients are followed every 6 months for 5 years and then annually thereafter.
- Primary Outcome Measures
Name Time Method overall survival Up to 10 years
- Secondary Outcome Measures
Name Time Method disease free survival Up to 10 years
Trial Locations
- Locations (36)
Wellspan Health - York Cancer Center
πΊπΈYork, Pennsylvania, United States
Winship Cancer Institute of Emory University
πΊπΈAtlanta, Georgia, United States
Beth Israel Deaconess Medical Center
πΊπΈBoston, Massachusetts, United States
Cleveland Clinic Taussig Cancer Center
πΊπΈCleveland, Ohio, United States
Veterans Affairs Medical Center - Seattle
πΊπΈSeattle, Washington, United States
University of Texas - MD Anderson Cancer Center
πΊπΈHouston, Texas, United States
University Cancer Center at University of Washington Medical Center
πΊπΈSeattle, Washington, United States
Washington University School of Medicine
πΊπΈSaint Louis, Missouri, United States
UCSF Comprehensive Cancer Center
πΊπΈSan Francisco, California, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
πΊπΈNashville, Tennessee, United States
LDS Hospital
πΊπΈSalt Lake City, Utah, United States
St. Vincent Cancer Center
πΊπΈLittle Rock, Arkansas, United States
Walter Reed Army Medical Center
πΊπΈWashington, District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute
πΊπΈTampa, Florida, United States
Southern Illinois University School of Medicine
πΊπΈSpringfield, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
πΊπΈIowa City, Iowa, United States
Northeast Heights Cancer Center
πΊπΈAlbuquerque, New Mexico, United States
Kansas Cancer Institute at the University of Kansas Medical Center
πΊπΈKansas City, Kansas, United States
Memorial Sloan-Kettering Cancer Center
πΊπΈNew York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
πΊπΈRochester, New York, United States
Comprehensive Cancer Center at Wake Forest University
πΊπΈWinston-Salem, North Carolina, United States
American Fork Hospital
πΊπΈAmerican Fork, Utah, United States
Utah Valley Regional Medical Center - Provo
πΊπΈProvo, Utah, United States
Wilford Hall Medical Center
πΊπΈLackland Air Force Base, Texas, United States
McKay-Dee Hospital Center
πΊπΈOgden, Utah, United States
Dixie Regional Medical Center
πΊπΈSaint George, Utah, United States
Fletcher Allen Health Care - Medical Center Campus
πΊπΈBurlington, Vermont, United States
Veterans Affairs Medical Center - Richmond
πΊπΈRichmond, Virginia, United States
Sentara Norfolk General Hospital
πΊπΈNorfolk, Virginia, United States
Madigan Army Medical Center
πΊπΈTacoma, Washington, United States
Margaret and Charles Juravinski Cancer Centre
π¨π¦Hamilton, Ontario, Canada
Vancouver General Hospital
π¨π¦Vancouver, British Columbia, Canada
Cancer Care Ontario-London Regional Cancer Centre
π¨π¦London, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
π¨π¦Toronto, Ontario, Canada
Princess Margaret Hospital
π¨π¦Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Quebec
π¨π¦Quebec City, Quebec, Canada