Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence
RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III Randomized Prospective Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence|
- Number of Patients with Disease-free Survival at 5 Years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 1999|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Experimental: Arm I - Leuprolide + Flutamide
Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year.
10.8 mg intramuscularly once every 3 months for 12 months
Other Names:Drug: Leuprolide Acetate
50 mg tablet orally daily for 12 months
No Intervention: Arm II - No Treatment
Arm II: Patients receive no initial treatment.
- 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 progression.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003645
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Curtis A. Pettaway, MD||M.D. Anderson Cancer Center|
|Study Chair:||Michael O. Koch, MD||Indiana University Melvin and Bren Simon Cancer Center|