MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer
Recruitment status was: Recruiting
|Prostate Cancer||Procedure: Core Needle TRUS Needle biopsy (Transrectal ultrasound) Procedure: Core Needle MRI/US image fusion guided needle biopsy|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer. A Phase III Study|
- 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.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|