Radiation Therapy Compared With No Further Treatment Following Surgery in Treating Patients With Prostate Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer.
PURPOSE: Randomized phase III trial to compare radiation therapy with no further treatment in treating patients with stage III prostate cancer following radical prostatectomy.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||PHASE III STUDY OF POST-OPERATIVE EXTERNAL RADIOTHERAPY IN PATHOLOGICAL STAGE T3 N0 PROSTATIC CARCINOMA|
|Study Start Date:||December 1992|
|Primary Completion Date:||December 2001 (Final data collection date for primary outcome measure)|
- Compare local recurrence rates, acute and late morbidity, overall survival, disease-free survival, and cancer-related survival of patients with pT3 pN0 adenocarcinoma of the prostate randomized following radical prostatectomy to postoperative conventional pelvic irradiation (60 Gy) vs no further treatment until relapse.
- Better define the selective pathologic indications for radiotherapy in patients with pT3 pN0 disease.
OUTLINE: This is a randomized study.
- Arm I: Patients undergo radiotherapy daily, 5 days a week, for 5 weeks, followed by boost radiotherapy for 1-1.4 weeks.
- Arm II: Patients are observed. Local relapse is treated with conventional pelvic radiotherapy.
Patients are followed every 3 months during the first postoperative year, every 6 months until the fifth year, and annually thereafter.
PROJECTED ACCRUAL: A total of 1000 patients will be accrued for this study within 7.5 years.
|Leuven, Belgium, B-3000|
|Study Chair:||Michel Bolla, MD||CHU de Grenoble - Hopital de la Tronche|
|Study Chair:||Hein van Poppel, MD, PhD||U.Z. Gasthuisberg|