MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01566045|
Recruitment Status : Unknown
Verified May 2013 by Philips Healthcare.
Recruitment status was: Recruiting
First Posted : March 29, 2012
Last Update Posted : May 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: Core Needle TRUS Needle biopsy (Transrectal ultrasound) Procedure: Core Needle MRI/US image fusion guided needle biopsy||Not Applicable|
The efficacy of targeting lesions for surgery may be limited by the visibility of a target during the procedure. The successful outcome of surgical intervention depends upon accurate device placement, which may be very challenging in certain settings, such as when a kidney tumor only is visible for a brief moment during the transient arterial phase of a contrast injection, and soon disappearing on dynamic imaging.
Historically, prostate cancer was diagnosed by digitally guided trans-rectal prostate biopsies. With PSA (Prostate SPecific Antigen) screening and improvements in ultrasonography, trans-rectal ultrasound (TRUS) guided prostate biopsy have become the standard of care to screen and diagnose localized prostate cancer. Standard US 12-14 core prostate biopsy is now common practice, detecting cancer in 27% to 44% of patients.
Prostate MR imaging with the addition of an endorectal-coil probe and a 3 Tesla magnet dramatically improves diagnostic utility dramatically but biopsies are difficult, time-consuming, and require specialized equipment, which increases the cost significantly.
To meet this challenge TRUS images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system. The urologist then performs directed prostate biopsies at MR-identified targets in addition to the standard 12-14 core biopsies.
This study will consist of comparison of the standard of care (TRUS guided prostate biopsy) with the protocol biopsy which consists of a TRUS guided prostate biopsy and a MR/US fusion tracked prostate biopsy. Each patient will act as their own control.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||980 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer. A Phase III Study|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||April 2015|
Active Comparator: Core Needle TRUS biopsy (Transrectal ultrasound)
Patient receiving core needle TRUS biopsy (Standard of care biopsy)
Procedure: Core Needle TRUS Needle biopsy (Transrectal ultrasound)
Standard of care 12-core TRUS sextant needle biopsy of the medial and lateral margins of the right and left apex, mid-gland and base of the prostate
Experimental: Core Needle MRI/US fusion guided biopsy
Patients receiving Standard of Care core needle TRUS biopsy will then receive the MRI / Ultrasound fusion core needle guided biopsy
Procedure: Core Needle MRI/US image fusion guided needle biopsy
Directed prostate needle biopsies at MR-image identified targets in addition to the standard ultrasound 12-14 core biopsies
- Number of prostate lesions [ Time Frame: Day 1 ]To determine if the number of prostate lesions identified by targeted (MR / US fusion biopsy) plus conventional biopsy is statitically greater than the number of lesions identified conventional biopsy alone. The number of positive lesions identified by both techniques will be compared.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566045
|United States, New York|
|The Arthur Smith Institute for Urology||Recruiting|
|New Hyde Park, New York, United States, 11040|
|Contact: Art Rastinehad, MD 516-734-8500 firstname.lastname@example.org|
|Principal Investigator: Ardeshir R Rastinehad, DO|
|Sub-Investigator: David N Siegel, MD|
|Sub-Investigator: Eran Ben-Levi, MD|