Urology of Virginia Case Series
Condition: Prostate Cancer; Cancer of the PROSTATE; Prostatic Neoplasm
MeSH terms: Prostatic Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Ultrasound guided prostate exam using SOC ultrasound system; mpMRI guided prostate examination using PI-RADS v2; High-resolution micro-ultrasound guided prostate biopsy
Intervention type(s): Device; Device; Device
Intervention description(s): mpMRI guided prostate examination using standard of care MRI system
Other intervention name(s): ExactVu micro-ultrasound imaging system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility