Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer
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.
Procedure: conventional surgery
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|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)|
- 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.