Radiation Therapy Compared With No Further Treatment Following Surgery in Treating Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00002511
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1005
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium