Urology of Virginia Case Series
Urology of Virginia Case Series
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.
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.
Inclusion Criteria:

 1. 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.

 2. PSA<50

 3. Clinical stage < cT2c

 Exclusion Criteria:

 Patients will be excluded from being included in the investigation if any of the following
 is true:

 1. Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia

 2. Men with known prostate volume (from prior imaging) of > 60cc

 3. Men with anorectal abnormalities preventing TRUS-guided prostate biopsy

 4. Men who are unable to provide their own informed consent

 5. Men who have contraindications to MRI or gadolinium chelate contrast