Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: dutasteride; Other: placebo

• Registration Number: NCT00398281
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-09
• Study First Submitted QC: 2006-11-09
• Study First Posted: 2006-11-10
• Status Verified: 2009-06
• Primary Completion: 2010-07
• Study Completion: 2012-09
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm I	dutasteride	Patients receive oral dutasteride once daily on days 1-14.
Arm II	placebo	Patients receive oral placebo once daily on days 1-14.

Primary Outcome Measures

Name	Time	Method
Cost effectiveness of contrast-enhanced ultrasound
Efficacy of short-term dutasteride in improving prostate cancer detection
Detection rate of prostate cancer

Trial Locations

Locations (1)

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States