Urology of Virginia Case Series

Study Overview
=================
Brief Summary
-----------------
The investigational protocol describes a small case series designed to compare three imaging modalities for use in visualizing prostate cancer. The three modalities to be tested are: transrectal micro-ultrasound , and conventional resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI (mpMRI). These modalities will be used for guiding systematic (standard, random, extended sextant) plus image-guided targeted prostate biopsies among men with known cancer and an indication for prostate biopsy. In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the radiology report used for targeting.

Detailed Description
-----------------
This trial will enroll nine men with an indication for a prostate biopsy. The primary objective of the study is to provide guidance to clinicians who will be using the ExactVu system on the appearance of suspicious foci, and the difference between the appearance of these foci in LR-TRUS, mpMRI and transrectal micro-ultrasound images. The study is being conducted based on the hypothesis that a series of same-subject comparisons will clearly demonstrate the differences in appearance between the modalities. Procedures in the study are: obtain informed consent for the subject image the subject using mpMRI according to the PI-RADS v2 protocol, and obtain radiologist's report perform biopsy procedure using micro-ultrasound (this may be conducted in a separate subject visit) prepare biopsy specimens for pathology record all procedure details in a case report form, including pathology and mpMRI reports The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Secondary endpoints are the pathological result of each biopsy sample (Gleason Score and percentage of cancer in sample), and risk score identified on imaging. Both of these values are per-sample, with 12 systematic samples per subject plus any additional targeted samples warranted by standard of care.

Official Title
-----------------
Urology of Virginia Case Series

Conditions
-----------------
Prostate Cancer, Cancer of the PROSTATE, Prostatic Neoplasm

Intervention / Treatment
-----------------
* Device: Ultrasound guided prostate exam using SOC ultrasound system
* Device: mpMRI guided prostate examination using PI-RADS v2
* Device: High-resolution micro-ultrasound guided prostate biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All men ≥ 40 years age and <80 years of age with a history of prostate cancer and an indication for a prostate biopsy will be offered inclusion in the study. Typical indications for biopsy include abnormal PSA (prostate specific antigen) and/or abnormal DRE (digital rectal exam) and/or history of prostate cancer. PSA<50 Clinical stage < cT2c Exclusion Criteria: Patients will be excluded from being included in the investigation if any of the following is true: Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia Men with known prostate volume (from prior imaging) of > 60cc Men with anorectal abnormalities preventing TRUS-guided prostate biopsy Men who are unable to provide their own informed consent Men who have contraindications to MRI or gadolinium chelate contrast

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micro-ultrasound<br>Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities: Low resolution transrectal ultrasound examination (LR-TRUS) Multi-parametric MRI (mpMRI) examination performed according to the PI-RADS v2 protocol | Device: Ultrasound guided prostate exam using SOC ultrasound system<br> <br> Device: mpMRI guided prostate examination using PI-RADS v2<br>* mpMRI guided prostate examination using standard of care MRI system<br>Device: High-resolution micro-ultrasound guided prostate biopsy<br> <br> * Other names: ExactVu micro-ultrasound imaging system;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keyword Description of Each Biopsy Sample | The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound. | For each patient, keywords will be assigned within one week following the patient's procedure. |