NCT04026763

MR/TRUS Fusion Guided Prostate Biopsy

MR/TRUS Fusion Guided Prostate Biopsy- An Improved Way To Detect And Quantify Prostate Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will determine if targeted (Magnetic Resonance (MR) / Ultrasound (US) fusion biopsy) plus conventional biopsy is superior to conventional biopsy alone in diagnosing subjects with prostate cancer.

Detailed description

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.

Conditions

• Prostate Disease
• Elevated Prostate Specific Antigen
• Family History of Prostate Cancer
• Positive Digital Rectal Exam

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2018-05-11
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2019-07-19
• Last updated: 2019-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study