A PHASE III TRIAL COMPARING WHOLE PELVIC IRRADIATION FOLLOWED BY A CONEDOWN BOOST TO BOOST IRRADIATION ONLY AND COMPARING NEOADJUVANT TO ADJUVANT TOTAL ANDROGEN SUPPRESSION (TAS)
OBJECTIVES: I. Examine whether total androgen suppression (TAS) with flutamide/goserelin and
whole-pelvic irradiation followed by a cone-down boost to the prostate improves
progression-free survival at 5 years by at least 10% compared to TAS and prostate-only
irradiation in patients with adenocarcinoma of the prostate at significant risk of nodal
involvement. II. Examine whether induction and concurrent (neoadjuvant) TAS and radiotherapy
improves the progression-free survival at 5 years by at least 10% compared to adjuvant TAS
and radiotherapy. III. Compare treatments with regard to local control, time to distant
failure, and overall survival.
OUTLINE: Randomized study. Arm I: Neoadjuvant Antiandrogen Therapy with Radiotherapy.
Flutamide, FLUT, NSC-147834; Goserelin, Zoladex, ZDX, NSC-606864; with irradiation of the
whole pelvis followed by a boost to the prostate using photons of at least 6 MV. Arm II:
Neoadjuvant Antiandrogen Therapy with Radiotherapy; FLUT; ZDX; with irradiation of the
prostate using equipment as in Arm I. Arm III: Radiotherapy followed by Adjuvant
Antiandrogen Therapy. Irradiation as in Arm I; followed by FLUT; ZDX. Arm IV: Radiotherapy
followed by Adjuvant Antiandrogen Therapy. Irradiation as in Arm II; followed by FLUT; ZDX.
PROJECTED ACCRUAL: 1,200 patients will be accrued over 2.5 years.
Primary Purpose: Treatment
Mack Roach, MD
University of California, San Francisco
United States: Federal Government