NCT01566045

MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer

MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer. A Phase III Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Philips Healthcare · Industry
• Sex: Male
• Age: 18 Years – 120 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 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2012-03-29
• Last updated: 2021-04-28

Locations

1 site across 1 country: United States