Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398281
Status:
COMPLETED
Last Update Posted:
2014-01-10
First Post:
2006-11-09
Brief Title:
Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TJUH-06F-145 | None | None | None |