Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy
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|ClinicalTrials.gov Identifier: NCT00403000|
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : May 1, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: dutasteride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Dutasteride in Prostate Cancer Recurrent During Androgen Deprivation Therapy|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||April 2013|
- Drug: dutasteride
- Time to disease progression [ Time Frame: Every 12 weeks ]
- Toxicity [ Time Frame: Daily while on Treatment ]
- Objective response (complete and partial) rate and serum prostate-specific antigen levels [ Time Frame: Every 4 weeks ]
- Survival [ Time Frame: Every 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00403000
|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|