PHASE III STUDY OF POST-OPERATIVE EXTERNAL RADIOTHERAPY IN PATHOLOGICAL STAGE T3 N0 PROSTATIC CARCINOMA
- 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
- 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
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.
Primary Purpose: Treatment
Michel Bolla, MD
CHU de Grenoble - Hopital de la Tronche
United States: Federal Government