Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
Drug: Doxorubicin hydrochloride
Drug: Estramustine Phosphate Sodium
Drug: Therapeutic Hydrocortisone
Procedure: Conventional Surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate|
- Time to Progression [ Time Frame: From baseline to post treatment (minimally 24+ weeks) ] [ Designated as safety issue: No ]
|Study Start Date:||August 1996|
|Study Completion Date:||June 2005|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Arm I: Medical or surgical castration followed by an anti-androgen therapy with either flutamide, bicalutamide, or nilutamide.
Other Name: CasodexDrug: Flutamide
Other Name: EulexinDrug: Nilutamide
Other Names:Procedure: Conventional Surgery
Other Name: Castration
Experimental: Arm II
Arm II: Chemo/hormonal therapy for 3 x 8-week courses, followed by total androgen blockade. Each course consists of 6 weeks of cytotoxic therapy with doxorubicin, ketoconazole, vinblastine, and estramustine followed by 2 weeks rest. Maintained on hydrocortisone both during treatment and during rest.
Drug: Doxorubicin hydrochloride
Other Names:Drug: Estramustine Phosphate Sodium
Other Name: EmcytDrug: Ketoconazole
Other Name: NizoralDrug: Therapeutic Hydrocortisone
Other Names:Drug: Vinblastine
Other Name: Velban
- Determine the clinical benefit, as measured by time to progression and overall survival, of chemo/hormonal therapy compared to androgen ablation alone, when given as the initial systemic treatment in patients with acinar adenocarcinoma of the prostate that is not amenable to local therapy.
- Validate the clinical significance of PSA criteria for progression.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients are treated with medical or surgical castration followed by an anti-androgen therapy with either flutamide, bicalutamide, or nilutamide.
- Arm II: Patients receive chemo/hormonal therapy for 3 eight week courses, followed by total androgen blockade. Each course consists of 6 weeks of cytotoxic therapy with doxorubicin, ketoconazole, vinblastine, and estramustine followed by 2 weeks of rest. These patients are also maintained on hydrocortisone both during treatment and during rest.
Patients in arm II have a long-term central venous access device inserted.
PROJECTED ACCRUAL: A total of 368 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002855
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Randall E. Millikan, MD, PhD||M.D. Anderson Cancer Center|