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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|