MR/TRUS Fusion Guided Prostate Biopsy
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|ClinicalTrials.gov Identifier: NCT04026763|
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Disease Elevated Prostate Specific Antigen Family History of Prostate Cancer Positive Digital Rectal Exam||Procedure: prostate biopsy Procedure: MR US Fusion Guided Prostate Biopsy Device: MR/TRUS Fusion Guided Prostate 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 at 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 prostate biopsies.
This study will consist of comparison of the standard of care prostate biopsy with the protocol biopsy which consists of a US 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 :||520 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MR/TRUS Fusion Guided Prostate Biopsy- An Improved Way To Detect And Quantify Prostate Cancer|
|Actual Study Start Date :||May 11, 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Males with Prostate Cancer
Each participant will receive standard of care prostate biopsy as well as a US guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy guided prostate biopsy.
Procedure: prostate biopsy
standard of care
Procedure: MR US Fusion Guided Prostate Biopsy
Trans-rectal ultrasound (TRUS) guided fusion prostate biopsy, Transperineal Ultrasound guided fusion prostate biopsy
Other Name: Fusion Biopsy
Device: MR/TRUS Fusion Guided Prostate Biopsy
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 prostate biopsies.
- Incidence of Prostate Cancer [ Time Frame: Day 0 - day of procedure ]Incidence of diagnosing subjects with prostate cancer with MR visible lesions
- Incidence of adverse events [ Time Frame: 1 month ]the incidence of adverse events occurring after a targeted and ultrasound guided prostate biopsy
- Pirads score [ Time Frame: 1 month ]The Prostate Imaging Reporting and Data System (PIRADS) score classifies MRI lesions on a scale from 1 to 5, which reflects their level of suspicion from least to most. Higher score indicates more suspicion.
- Gleason score [ Time Frame: 1 month ]The Gleason Score ranges from 1-5 and describes how much the cancer from a biopsy looks like healthy tissue (lower score) or abnormal tissue (higher score). Sum of the gleason grade of the most predominant tumor pattern and a second gleason grade of the second most predominant pattern. Full score from 2 to 10, with higher score indicating more clinically significance.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026763
|Contact: Ardeshir Rastinehad, DOfirstname.lastname@example.org|
|Contact: Cynthia Knauer, RN, MSemail@example.com|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 11101|
|Principal Investigator: Ardeshir Rastinehad|
|Principal Investigator:||Ardeshir Rastinehad, DO||Icahn School of Medicine at Mount Sinai|