Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy

Not Applicable

• Conditions: Prostate Biopsy
• Interventions: Procedure: Transperineal mpMRI-US Fusion prostate biopsy; Procedure: Transrectal mpMRI-US Fusion prostate biopsy

• Registration Number: NCT03413137
• Lead Sponsor: Rabin Medical Center

Brief 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.

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-15
• Study Start: 2017-12-11
• Study First Submitted QC: 2018-01-21
• Last Update Submitted: 2018-01-28
• Study First Posted: 2018-01-29
• Last Update Posted: 2018-01-30
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 76

Inclusion Criteria

1. Men who are scheduled to undergo, transrectal or transperineal biopsy and have an MRI of the prostate.

   • Either primary biopsy or repeated biopsy

2. Age 18-90.

3. PI-RADS classification of 3-5

Exclusion Criteria

1. Men who do not have an MRI of the prostate.
2. PI-RADS classification of 2 or lower
3. Men who were diagnosed with prostate cancer and have begun treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Transrectal mpMRI-US Fusion prostate biopsy	A Transperineal mpMRI-US Fusion prostate biopsy followed by a Transrectal mpMRI-US Fusion prostate biopsy
Arm B	Transperineal mpMRI-US Fusion prostate biopsy	A Transrectal mpMRI-US Fusion prostate biopsy followed by a Transperineal mpMRI-US Fusion prostate biopsy
Arm B	Transrectal mpMRI-US Fusion prostate biopsy	A Transrectal mpMRI-US Fusion prostate biopsy followed by a Transperineal mpMRI-US Fusion prostate biopsy
Arm A	Transperineal mpMRI-US Fusion prostate biopsy	A Transperineal mpMRI-US Fusion prostate biopsy followed by a Transrectal mpMRI-US Fusion prostate biopsy

Primary Outcome Measures

Name	Time	Method
Detection rate for clinically significant prostate cancer	within 2 years	To compare the detection rate for clinically significant prostate cancer between transperineal vs transrectal mp-MRI-fusion/TRUS biopsies.

Secondary Outcome Measures

Name	Time	Method
Percentage of cores positive per region of interest (ROI)	within 2 years	To determine the accuracy of prostate cancer detection in transperineal vs transrectal mp-MRI-fusion/TRUS biopsies - Percentage of cores positive per region of interest (ROI)
Amount of volume of cores positive per region of interest (ROI)	within 2 years	To determine the accuracy of prostate cancer detection in transperineal vs transrectal mp-MRI-fusion/TRUS biopsies - Amount of volume of cores positive per region of interest (ROI)

Trial Locations

Locations (1)

Rabin Medical Center, Beilinson campus; 🇮🇱 Petach Tikva, Israel