Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy

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

Detailed Description
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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.

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

Conditions
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Prostate Biopsy

Intervention / Treatment
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* Procedure: Transperineal mpMRI-US Fusion prostate biopsy
* Procedure: Transrectal mpMRI-US Fusion prostate biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men who are scheduled to undergo, transrectal or transperineal biopsy and have an MRI of the prostate. • Either primary biopsy or repeated biopsy Age 18-90. PI-RADS classification of 3-5 Exclusion Criteria: Men who do not have an MRI of the prostate. PI-RADS classification of 2 or lower Men who were diagnosed with prostate cancer and have begun treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Using the NaviGo™ system each patient will undergo a biopsy using the transperineal followed by transrectal approach.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>A Transperineal mpMRI-US Fusion prostate biopsy followed by a Transrectal mpMRI-US Fusion prostate biopsy | Procedure: Transperineal mpMRI-US Fusion prostate biopsy<br>* 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).<br>* Other names: MRI-US Fusion TP;Procedure: Transrectal mpMRI-US Fusion prostate biopsy<br>* 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.<br>* Other names: MRI-US Fusion TR;|
| Active Comparator: Arm B<br>A Transrectal mpMRI-US Fusion prostate biopsy followed by a Transperineal mpMRI-US Fusion prostate biopsy | Procedure: Transperineal mpMRI-US Fusion prostate biopsy<br>* 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).<br>* Other names: MRI-US Fusion TP;Procedure: Transrectal mpMRI-US Fusion prostate biopsy<br>* 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.<br>* Other names: MRI-US Fusion TR;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, transperineal mp-MRI-fusion/TRUS biopsies, mp-MRI fusion/TRUS transrectal biopsy