A Phase 3 Trial of Androgen Ablation Alone vs. Chemo/Hormonal Therapy as Initial Treatment of Unresectable/Metastatic Adenocarcinoma of the Prostate
- 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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Progression
From baseline to post treatment (minimally 24+ weeks)
Randall E. Millikan, MD, PhD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|