Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy

Clalit Health Services

Status: Unknown

Conditions: Prostate Biopsy

Treatments: Procedure: Transperineal mpMRI-US Fusion prostate biopsy; Procedure: Transrectal mpMRI-US Fusion prostate biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT03413137

0618-17-RMC

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Arm A

Active Comparator group

Description:

A Transperineal mpMRI-US Fusion prostate biopsy followed by a Transrectal mpMRI-US Fusion prostate biopsy

Treatment:

Procedure: Transrectal mpMRI-US Fusion prostate biopsy

Procedure: Transperineal mpMRI-US Fusion prostate biopsy

Arm B

Active Comparator group

Description:

A Transrectal mpMRI-US Fusion prostate biopsy followed by a Transperineal mpMRI-US Fusion prostate biopsy

Treatment:

Procedure: Transrectal mpMRI-US Fusion prostate biopsy

Procedure: Transperineal mpMRI-US Fusion prostate biopsy