Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy

Study Overview
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Brief Summary
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The purpose of this study is to utilize this technology in the early detection and staging of pathologic states within prostate cancer patients using the information obtained on mpMRI and serum biomarkers from the patient's blood (if collected). Ultimately, investigators hope to improve the diagnostic accuracy and treatment selection process for these patients. Applying the fusion software which adds mpMRI to ultrasound images in real time, to an otherwise clinically standard but non-targeted ultrasound-guided prostate biopsy procedure will help with accurate and early diagnosis of prostate cancer.

Official Title
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Improved Detection and Localization Accuracy of Early Aggressive Prostate Adenocarcinoma Using Novel MR-directed Ultrasound-guided (MRdUSg) Prostate Biopsy Technique

Conditions
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Prostate Cancer, Prostate Adenocarcinoma

Intervention / Treatment
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* Diagnostic Test: TRUS biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to give informed consent Male - age > 18 mpMRI within the previous 6 months (PIRADS 3,4,5, all stages of PCa) Scheduled for TRUS biopsy for prostate lesion or mass Exclusion Criteria: Age under 18 years of age. Female Pre-existing blood dyscrasias Inability to perform TRUS due to anal sphincter closure/surgery Patients needing general anesthesia Patients allergic to lidocaine Patients allergic or unable to take antibiotics

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All subjects<br>The experimental conditions will include a standard prostate biopsy using an FDA-approved ultrasound machine with application of the experimental (non-FDA approved) image fusion software. | Diagnostic Test: TRUS biopsy<br>* The biopsy procedure will be completed using an FDA-approved ultrasound machine with the addition of an investigational (non-FDA approved) image fusion software.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate investigational fusion software. | To evaluate the sensitivity of the investigational software to aid in targeted biopsy of prostate lesions seen on pre-biopsy mpMRI. | Through study completion, planned 5 year duration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess accuracy of mpMRI. | To assess the diagnostic accuracy of Multiparametric Magnetic Resonance Imaging (mpMRI) provided Prostate Imaging Reporting and Data System (PIRADS) with pathology as the reference standard. The research-only procedure of collecting blood will be drawn during the scheduled biopsy visit, using no more than 15 minutes when the subject would already be at the visit. TRUS biopsy is standard of care. Experimental software will be added during the TRUS biopsy, at the time of needle localization. The software performs a computation on the ultrasound machine that fuses the pre-biopsy mpMRI images with the real-time ultrasound images. | Through study completion, planned 5 year duration. | 
| Assess sensitivity of software. | To assess the sensitivity of the investigation software in successfully targeting clinically significant prostate cancer, defined as Gleason score of 3+4 or greater. The research-only procedure of collecting blood will be drawn during the scheduled biopsy visit, using no more than 15 minutes when the subject would already be at the visit. TRUS biopsy is standard of care. Experimental software will be added during the TRUS biopsy, at the time of needle localization. The software performs a computation on the ultrasound machine that fuses the pre-biopsy mpMRI images with the real-time ultrasound images. | Through study completion, planned 5 year duration. | 
| Correlation of imaging with biomarkers. | To correlate Prostate Imaging Reporting and Data System (PIRADS) score from Multiparametric Magnetic Resonance Imaging (mpMRI) with cellular/ molecular biomarkers of aggressive cancer in the biopsy tissue samples. The research-only procedure of collecting blood will be drawn during the scheduled biopsy visit, using no more than 15 minutes when the subject would already be at the visit. TRUS biopsy is standard of care. Experimental software will be added during the TRUS biopsy, at the time of needle localization. The software performs a computation on the ultrasound machine that fuses the pre-biopsy mpMRI images with the real-time ultrasound images. | Through study completion, planned 5 year duration. |