Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00002855|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 30, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Bicalutamide Drug: Doxorubicin hydrochloride Drug: Estramustine Phosphate Sodium Drug: Flutamide Drug: Ketoconazole Drug: Nilutamide Drug: Therapeutic Hydrocortisone Drug: Vinblastine Procedure: Conventional Surgery||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||306 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate|
|Study Start Date :||August 1996|
|Primary Completion Date :||June 2005|
|Study Completion Date :||June 2005|
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
- Time to Progression [ Time Frame: From baseline to post treatment (minimally 24+ weeks) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|