MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy

Study Overview
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Brief Summary
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The purpose of this study is to find out how best to detect clinically significant lesions of prostate cancer by using micro-ultrasound technology (ExactVu) and by multiparametric magnetic-resonance imaging (mpMRI).

Detailed Description
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This is a pilot clinical trial with 30 patients with either: 1) suspected prostate cancer (based on elevated PSA or abnormal digital rectal exam (DRE), or 2) known low-risk prostate cancer being managed with active surveillance. Enrolled patients will undergo MRI fusion biopsy and standard-template 12 core TRUS biopsy as the standard-of-care. Patients will also undergo micro-ultrasound evaluation and targeted biopsy if lesions are identified. Detection rates of clinically significant lesions by ExactVu and by MRI will be compared.

Official Title
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MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy for the Detection of Clinically Significant Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Standard of Care Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to undergo biopsy and with one of the following: Men with suspicion of prostate cancer Men on active surveillance Age ≥18 [30] Have available multiparametric prostate MRI Able to provide written, informed consent No significant medical illness which in the opinion of the Investigator would preclude entry to study procedures Be willing and able to comply with scheduled visits Exclusion Criteria: Previously confirmed prostate cancer diagnosis with Grade Group >= 2 Unable to undergo prostate biopsy Prostate MRI unable to be evaluated using the PI-RADS v2 criteria Men with contraindication for MRI or a prostate biopsy Prostate biopsy within 8 weeks prior to mpMRI. Any history of prostate treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Standard of Care Biopsy|Patients will be evaluated with multiparametric MRI prostate followed by ExactVu micro-ultrasound to identify target lesions all of which will be biopsied by the examiner|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection Rate | To compare the detection rates of clinically significant prostate cancer lesions by ExactVu micro-ultrasound and by MRI-fusion | 2 years | 
| Feasibility of ExactVu | To determine the feasibility of using ExactVu micro-ultrasounds to screen for prostate cancer in socioeconomically disadvantaged populations with limited access to care. Feasibility is measured by the percentage of patients that successfully undergo the study procedures. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive Performance Measures | To evaluate the sensitivity of ExactVu micro-ultrasound method and MRI-fusion method in detection of prostate cancer | 2 years | 
| Predictive Performance Measures | To evaluate the negative predictive value of ExactVu micro-ultrasound method and MRI-fusion method in detection of prostate cancer | 2 years |