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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03413137
Other study ID # 0618-17-RMC
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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