Phase II Study of Dutasteride in Prostate Cancer Recurrent During Androgen Deprivation Therapy
- Evaluate the time to disease progression in patients with recurrent prostate cancer
that progressed during androgen-deprivation therapy who are treated with dutasteride.
- Evaluate the toxicity of dutasteride in these patients.
- Evaluate the serum prostate-specific antigen (PSA) level and objective radiographic
response rate in patients treated with dutasteride.
- Determine the survival of patients treated with dutasteride.
- Determine the quality of life of patients treated with dutasteride.
OUTLINE: Patients receive oral dutasteride once daily until disease progression or
Quality of life is assessed at baseline and then every 3 months thereafter.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to disease progression
Every 12 weeks
James L. Mohler, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|