Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride
Overview
- Phase
- Phase 3
- Intervention
- dutasteride
- Conditions
- Prostate Cancer
- Sponsor
- Sidney Kimmel Cancer Center at Thomas Jefferson University
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Cost effectiveness of contrast-enhanced ultrasound
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
OBJECTIVES: * 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Patients receive oral dutasteride once daily on days 1-14.
Intervention: dutasteride
Arm II
Patients receive oral placebo once daily on days 1-14.
Intervention: placebo
Outcomes
Primary Outcomes
Cost effectiveness of contrast-enhanced ultrasound
Efficacy of short-term dutasteride in improving prostate cancer detection
Detection rate of prostate cancer