Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00398281|
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : January 10, 2014
RATIONALE: Diagnostic procedures, such as ultrasound-guided biopsy, may help find prostate cancer. Dutasteride may improve the ability of ultrasound-guided biopsy to find prostate cancer. It is not yet known whether dutasteride followed by ultrasound-guided biopsy is more effective than a placebo followed by ultrasound-guided biopsy in finding prostate cancer.
PURPOSE: This randomized phase III trial is studying dutasteride and ultrasound-guided biopsy to see how well they find prostate cancer compared with a placebo and ultrasound-guided biopsy.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: dutasteride Other: placebo||Phase 3|
- Determine the efficacy of dutasteride followed by contrast-enhanced, ultrasound-guided targeted biopsy in detecting prostate cancer.
- Determine the detection rate of prostate cancer with targeted biopsy using contrast-enhanced ultrasound combined with dutasteride.
- Determine the efficacy of targeted biopsy using contrast-enhanced ultrasound vs systematic biopsy in diagnosing clinically significant prostate cancer.
- Determine the reduction in post-biopsy bleeding after dutasteride in these patients.
- Determine the cost effectiveness of this regimen in these patients.
OUTLINE: This is a prospective, double-blind, placebo-controlled, randomized study. Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral dutasteride once daily on days 1-14.
- Arm II: Patients receive oral placebo once daily on days 1-14. On day 14, patients in both arms undergo blood collection and contrast-enhanced (perflutren protein-type A microspheres) transrectal ultrasound. Conventional gray-scale imaging, color Doppler imaging, and power Doppler imaging are performed. Biopsies are then performed; first up to 6 targeted ultrasound-guided biopsies and then up to 12 systematic biopsies.
After completion of study procedures, patients are followed at 1 day.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Official Title:||Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||September 2012|
Experimental: Arm I
Patients receive oral dutasteride once daily on days 1-14.
Placebo Comparator: Arm II
Patients receive oral placebo once daily on days 1-14.
- Efficacy of short-term dutasteride in improving prostate cancer detection
- Detection rate of prostate cancer
- Cost effectiveness of contrast-enhanced ultrasound
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): NCT00398281
|United States, Pennsylvania|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19107-5541|
|Principal Investigator:||Ethan J. Halpern, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|