Three Dimensional Conformal Radiotherapy / Intensity Modulated Radiotherapy Alone Vs Three Dimensional Conformal Therapy / Intensity Modulated Radiotherapy Plus Adjuvant Hormonal Therapy In Localized T1b-c, T2a, N0, M0 Prostatic Carcinoma. A Phase III Randomized Study
- Compare the potential beneficial impact of radiotherapy with or without adjuvant
bicalutamide and goserelin on the long-term outcome of patients with localized prostate
- Compare the acute and late radiation-induced side effects of these regimens in these
- Compare the biochemical/clinical disease-free survival, overall survival, and time to
local progression in patients treated with these regimens.
- Compare the time to clinical biological failure or death in patients treated with these
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor
class (T1b-c vs T2a), initial prostate-specific antigen level (10 ng/mL vs 10-20 ng/mL vs
greater than 20 ng/mL), Gleason score (2-6 vs 7-10) and participating center. Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo 3-dimensional conformal radiotherapy or intensity-modulated
radiotherapy once daily 5 days a week for 7-7.5 weeks.
- Arm II: Patients receive adjuvant oral bicalutamide once daily on days 1-30 and
goserelin subcutaneously on days 8 and 98. Beginning on day 8, patients undergo
radiotherapy as in arm I.
Quality of life is assessed at baseline and then at months 6, 12, 24, and 36.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this
study within 5 years.
Allocation: Randomized, Primary Purpose: Treatment
Biochemical and clinical disease-free survival as measured by Logrank prostate-specific antigen progression every 6 months until year 5, and annually thereafter
Michel Bolla, MD
CHU de Grenoble - Hopital de la Tronche
United States: Federal Government