N/A
N=9
Urology of Virginia Case Series
Prostate Cancer · Cancer of the PROSTATE · Prostatic Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT03035487 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Keyword Description of Each Biopsy Sample — 89 percentage significant cancers detected
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- Exact Imaging
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Keyword Description of Each Biopsy Sample |
89 | — |
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.
Eligibility Criteria
Inclusion Criteria
- All men ≥ 40 years age and 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
Data sourced from ClinicalTrials.gov (NCT03035487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.