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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
overall survival
Time frame: Up to 10 years
disease free survival
Time frame: Up to 10 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St. Vincent Cancer Center
Little Rock, Arkansas, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Walter Reed Army Medical Center
Washington D.C., 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
St Louis, Missouri, United States
...and 26 more locations