N/A
Completed N=9
Urology of Virginia Case Series
Prostate Cancer · Cancer of the PROSTATE
Source: ClinicalTrials.gov NCT03035487 ↗
Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Keyword Description of Each Biopsy Sample — 89 percentage significant cancers detected
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Keyword Description of Each Biopsy Sample |
89 | — |
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. Informational only — not medical advice.