Long Term Adjuvant Hormonal Treatment With LHRH Analogue Versus No Further Treatment in Locally Advanced Prostatic Carcinoma Treated by External Irradiation and a Six Months Combined Androgen Blockade - A Phase III Study
- Determine the best hormonal scheme to be associated with pelvic radiotherapy in the
curative management of prostatic carcinoma for hormonal treatment with regards to
treatment outcome (overall survival, clinical disease free survival, local regional
control), quality of life (treatment side effects, sexual function), and health economy
(cost effectiveness ratio).
OUTLINE: This is a randomized, multicenter study.
Patients receive external radiation for 5 weeks, followed by a pelvic boost given for 2
weeks and a 6 month combined androgen blockage initiated at the onset of external
irradiation. Flutamide (Eulexin) or bicalutamide (Casodex) may be used as the antiandrogens.
Antiandrogen treatment starts 1 week before the first injection of triptorelin.
Patients are then randomized to one of two treatment arms.
- Arm I: Patients receive no further treatment.
- Arm II: Patients receive antiandrogen for 2.5 years plus and LHRH analogue
(triptorelin) administered every 3 months. Patients then continue the LHRH analogue
alone for an additional 2.5 years in the absence of disease progression.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 966 patients will be accrued over 5 years.
Allocation: Randomized, Primary Purpose: Treatment
Michel Bolla, MD
CHU de Grenoble - Hopital de la Tronche
United States: Federal Government