Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy

Prostate Biopsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03413137
• Other study ID #: 0618-17-RMC
• Status: Recruiting
• Phase: N/A
• First received: October 15, 2017
• Last updated: January 28, 2018
• Start date: December 11, 2017
• Est. completion date: October 2019

Study information

• Verified date: October 2017
• Source: Rabin Medical Center
• Contact: Sivan Sela, B.Sc
• Phone: +972(0)3-9376553
• Email: Sivanto1[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Biopsy

Intervention

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).
• 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.

Locations

Country	Name	City	State
Israel	Rabin Medical Center, Beilinson campus	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate for clinically significant prostate cancer	To compare the detection rate for clinically significant prostate cancer between transperineal vs transrectal mp-MRI-fusion/TRUS biopsies.	within 2 years
Secondary	Percentage of cores positive per region of interest (ROI)	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)	within 2 years
Secondary	Amount of volume of cores positive per region of interest (ROI)	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)	within 2 years