A Phase III Randomized Prospective Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence
- Determine the effect of one year of adjuvant hormonal ablation on disease-free survival
at 5 years in node-negative radical prostatectomy patients at high risk for
- Determine the effect of this treatment on the incidence of androgen independent
prostate cancer and on disease specific and overall survival.
- Determine the impact of one year of total androgen ablation on quality of life and
serum testosterone levels.
- Assess differences in quality of life between wives of patients in the androgen
ablation condition compared to wives of patients in the control condition.
- Obtain blood samples from patients at high risk for failure post-prostatectomy to
evaluate serum markers of prognosis.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral
flutamide three times daily for 1 year.
- Arm II: Patients receive no initial treatment. Quality of life is assessed every 6
months for 5 years. Quality of life of wives/partners of patients is assessed every 6
months for two years.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 496 patients (248 per treatment arm) will be accrued for this
study within 3.5 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Disease-free Survival at 5 Years
Curtis A. Pettaway, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|University of Texas - MD Anderson Cancer Center
|Houston, Texas 77030-4009