Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy

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

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

Study Overview

• Status: Unknown
• Conditions: Prostate Biopsy
• Intervention / Treatment: Procedure: Transperineal mpMRI-US Fusion prostate biopsy; Procedure: Transrectal mpMRI-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 Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petach Tikva, Israel, 4941492
    • Recruiting
    • Rabin Medical Center, Beilinson campus
    • Contact: Sivan Sela, B.Sc; Phone Number: +972-3-9376553; Email: Sivanto1@clalit.org.il
    • Contact: Tzlil Tabachnik, M.Sc; Phone Number: +972-3-9376553; Email: Tzlilba1@clalit.org.il
    • Sub-Investigator: Daniel Halstuch, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A; A Transperineal mpMRI-US Fusion prostate biopsy followed by a Transrectal mpMRI-US Fusion prostate biopsy	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).; Other Names: MRI-US Fusion TP; 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.; Other Names: MRI-US Fusion TR
Active Comparator: Arm B; A Transrectal mpMRI-US Fusion prostate biopsy followed by a Transperineal mpMRI-US Fusion prostate biopsy	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).; Other Names: MRI-US Fusion TP; 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.; Other Names: MRI-US Fusion TR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: David Margel, MD PhD, Rabn Medical Center, Beilinson Campus

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2017
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: October 15, 2017
• First Submitted That Met QC Criteria: January 21, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 28, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Prostate cancer; transperineal mp-MRI-fusion/TRUS biopsies; mp-MRI fusion/TRUS transrectal biopsy
• Other Study ID Numbers: 0618-17-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No