Phase III Randomized Comparison of Pelvic Radiotherapy Alone vs Pelvic Radiotherapy Plus the LHRH Analogue Goserelin and Cyproterone Acetate in Carcinoma of the Prostate at High Risk for Metastasis
OBJECTIVES: I. Evaluate the ability of adjuvant hormone therapy with an LHRH agonist
(Goserelin depot) to produce an increased disease-free survival and to prolong overall
survival when initiated during the first week of radiotherapy in prostatic cancer patients
with a high risk of developing metastatic disease.
OUTLINE: Randomized study. Arm I: Radiotherapy. Whole-pelvic irradiation using photons with
a recommended energy of at least 10 MV (Co60 therapy is acceptable if higher energy
unavailable). Arm II: Radiotherapy plus 2-Drug Combination Hormonal Therapy. Whole-pelvic
irradiation as in Arm I; plus Goserelin, ZDX, NSC-606864; Cyproterone acetate, CPTR,
PROJECTED ACCRUAL: 400 patients will be entered over 5 years. At least 75 patients on each
arm should be followed until relapse.
Primary Purpose: Treatment
Michel Bolla, MD
CHU de Grenoble - Hopital de la Tronche
United States: Federal Government