Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy
RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dutasteride works in treating patients with recurrent prostate cancer that did not respond to androgen-deprivation therapy.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Dutasteride in Prostate Cancer Recurrent During Androgen Deprivation Therapy|
- Time to disease progression [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: Daily while on Treatment ] [ Designated as safety issue: Yes ]
- Objective response (complete and partial) rate and serum prostate-specific antigen levels [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
- Survival [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2004|
|Study Completion Date:||April 2013|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
- 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 unacceptable toxicity.
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.
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||James L. Mohler, MD||Roswell Park Cancer Institute|