Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03413137

Enrollment

Registered

2018-01-29

Start date

2017-12-11

Completion date

2019-10-31

Last updated

2018-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Biopsy

Keywords

Prostate cancer, transperineal mp-MRI-fusion/TRUS biopsies, mp-MRI fusion/TRUS transrectal biopsy

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.

Interventions

PROCEDURETransperineal 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).

PROCEDURETransrectal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Using the NaviGo™ system each patient will undergo a biopsy using the transperineal followed by transrectal approach.

Eligibility

Sex/Gender

MALE

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Israel

Contacts

Primary ContactSivan Sela, B.Sc

Sivanto1@clalit.org.il+972(0)3-9376553

Backup ContactTzlil Tabachnik, M.Sc

Tzlilta1@clalit.org.il+972(0)3-9376553

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026