Treatment of Metastatic Prostate Cancer That is Hormone-Independent: Evaluation of the Role of Chemotherapy on the Quality of Life of Patients. Phase II Study
OBJECTIVES: I. Determine the effect of weekly doxorubicin on the quality of life of patients
with metastatic, hormone-refractory, symptomatic prostate cancer. II. Determine the
contribution of this treatment on control of pain in these patients. III. Determine the
toxicity of this regimen in these patients. IV. Determine the objective response and
biological observations in these patients after this treatment. V. Determine the effect of
this regimen on survival of these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms. Arm I: Patients receive methylprednisolone IV weekly for 3 months. Arm II:
Patients receive methylprednisolone IV and doxorubicin IV weekly for 3 months. Quality of
life is assessed before treatment, every 4 weeks during treatment, and then every 3 months.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study within 3 years.
Allocation: Randomized, Primary Purpose: Treatment
Stephane Culine, MD
Centre Val d'Aurelle - Paul Lamarque
United States: Federal Government