Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer
Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride
Sponsor: National Cancer Institute (NCI)
A PHASE3 clinical study on Prostate Cancer, this trial is completed. The trial is conducted by National Cancer Institute (NCI) and has accumulated 7 data snapshots since 2006. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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.
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.
Status Flow
Change History
7 versions recorded-
Feb 2026 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Feb 2026 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 2 earlier versions
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE3
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Nov 2006
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Cancer Institute (NCI)
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
For direct contact, visit the study record on ClinicalTrials.gov .