Prostate Cancer Clinical Trial
Official title:
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
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bicalutamide and
goserelin may fight prostate cancer by reducing the production of testosterone. It is not
yet known if radiation therapy is more effective with or without bicalutamide and goserelin
in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with
or without bicalutamide and goserelin in treating patients who have localized prostate
cancer.
OBJECTIVES:
- Compare the potential beneficial impact of radiotherapy with or without adjuvant
bicalutamide and goserelin on the long-term outcome of patients with localized prostate
cancer.
- Compare the acute and late radiation-induced side effects of these regimens in these
patients.
- 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
regimens.
- 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
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