Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I, II, or III Adenocarcinoma of the Prostate
- Compare the survival without recurrence and overall survival of patients with stage I,
II, or III adenocarcinoma of the prostate after receiving radiotherapy to the prostate
with or without radiotherapy to the pelvis.
- Compare the toxic effects of these two regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Determine the prognostic factors of progression in these patients.
- Analyze the site of relapse (prostate, pelvic lymph nodes, metastases) in case of
progression in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating
center and prognostic group (poor vs good prognosis).
Patients are randomized to one of two treatment arms.
- Arm I: Patients receive pelvic irradiation plus local prostate irradiation.
- Arm II: Patients receive local prostate irradiation only. Radiotherapy in both arms is
administered 5 days a week for 7 weeks.
Quality of life is assessed before therapy, 12 months after therapy, and then annually
Patients are followed at 2 and 6 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.
Allocation: Randomized, Primary Purpose: Treatment
Pascal Pommier, MD
Centre Leon Berard
United States: Federal Government