Urology San Antonio MRI/MicroUS Comparison

Study Overview
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Brief Summary
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This study compares micro-ultrasound image targeted prostate biopsy with multi-parametric MRI targeted biopsy in men indicated for prostate biopsy due to suspicion of prostate cancer. Both imaging techniques will be applied to each subject and compared, along with systematic biopsy.

Detailed Description
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The investigational protocol describes a study designed to compare ultra-high resolution transrectal micro-ultrasound (micro-US), and multi-parametric MRI (mpMRI). These modalities are both used clinically to identify targets for prostate biopsy, however little data is available to compare their sensitivity. While mpMRI is used clinically to identify targets for biopsy, it is not used for real-time biopsy guidance due to challenges performing the biopsy procedure within the MRI gantry. Instead, targets identified on mpMRI are sampled during transrectal ultrasound guided biopsy as part of the prostate biopsy procedure, often using software assisted fusion products. For this investigation, the biopsy procedure will be guided by transrectal micro-US (current standard of care at Urology San Antonio), and will include systematic (standard, random, extended sextant) plus image-guided prostate biopsies among men with clinical suspicion of prostate cancer and an indication for prostate biopsy.

Official Title
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Urology San Antonio MRI/MicroUS Comparison

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: Micro-ultrasound targeted biopsy
* Diagnostic Test: mpMRI targeted biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men presenting for prostate biopsy due to clinical suspicion of prostate cancer 40-75 years old Available mpMRI images and report, performed according to the PI-RADS v2 standard Exclusion Criteria: Men with anorectal abnormalities preventing TRUS-guided prostate biopsy Men who are unable to provide their own informed consent Prostate volume on MRI > 100cc

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micro-Ultrasound Biopsy<br> | Diagnostic Test: Micro-ultrasound targeted biopsy<br>* Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system<br>|
| Experimental: MRI Targeted Biopsy<br> | Diagnostic Test: mpMRI targeted biopsy<br>* Multiparametric MRI targeted biopsy using software assisted MRI/US fusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinically Significant Cancer | Comparison of subject-level detection rate of clinically significant cancer (csPCa, defined as Grade Group 2 or higher) between micro-ultrasound targeted biopsy and mpMRI targeted biopsy. | At time of biopsy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiparametric MRI, micro-ultrasound, prostate biopsy