Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy
- Conditions
- Prostate Cancer
- Registration Number
- NCT00403000
- Lead Sponsor
- Roswell Park Cancer Institute
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 27
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Time to disease progression Every 12 weeks Toxicity Daily while on Treatment
- Secondary Outcome Measures
Name Time Method Objective response (complete and partial) rate and serum prostate-specific antigen levels Every 4 weeks Survival Every 12 weeks
Trial Locations
- Locations (1)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States