Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer
- Conditions
- Prostate Cancer
- 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
- 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)
St. Vincent Cancer Center
🇺🇸Little Rock, Arkansas, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Kansas Cancer Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Scroll for more (26 remaining)St. Vincent Cancer Center🇺🇸Little Rock, Arkansas, United States