NCT03413137

Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy

A Prospective Cohort Study Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy

Detailed description

This will be a prospective cohort trial that compares transperineal to transrectal MRI-US fusion prostate biopsy among men. The target population are males that are schedule to undergo MRI-US Fusion prostate biopsy and have an MRI of the prostate. All the pathological samples would be conducted from the area in the prostate that was found as suspicious of malignancy by previous MRI imaging, and defined as region of interest (ROI). First the prostate biopsy will be preformed in a transperineal approach; Then a transrectal approach would be used to sample a few more cores. The primary endpoint will be To compare the detection rate for clinically significant prostate cancer between transperineal vs transrectal mp-MRI-fusion/TRUS biopsies. Additionally, the study aims to determine the accuracy of prostate cancer detection in transperineal vs transrectal mp-MRI-fusion/TRUS biopsies.

Conditions

• Prostate Biopsy

Interventions

Type	Name	Description
PROCEDURE	Transperineal mpMRI-US Fusion prostate biopsy	mpMRI-US Fusion prostate biopsy in a transperineal approach to direct the needles towards an area in the prostate that was found as suspicious of malignancy by previous MRI imaging, defined as region of interest (ROI).
PROCEDURE	Transrectal mpMRI-US Fusion prostate biopsy	using the same system and MRI imaging, a transrectal approach would be used to sample a few more cores from the ROI as defined by the MRI imaging.

Timeline

• Start date: 2017-12-11
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2018-01-29
• Last updated: 2018-01-30

Locations

1 site across 1 country: Israel