N/A
N=120
Urology San Antonio MRI/MicroUS Comparison
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03762616 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants With Clinically Significant Cancer — 38; 31 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Micro-ultrasound targeted biopsy (Diagnostic_test); mpMRI targeted biopsy (Diagnostic_test)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- Exact Imaging
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Significant Cancer |
38; 31 | — |
Summary
This study compares micro-ultrasound image targeted prostate biopsy with multi-parametric MRI targeted biopsy in men indicated for prostate biopsy due to suspicion of prostate cancer. Both imaging techniques will be applied to each subject and compared, along with systematic biopsy.
Eligibility Criteria
Inclusion Criteria
- Men presenting for prostate biopsy due to clinical suspicion of prostate cancer
- 40-75 years old
- Available mpMRI images and report, performed according to the PI-RADS v2 standard
Exclusion Criteria
- Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
- Men who are unable to provide their own informed consent
- Prostate volume on MRI > 100cc
Data sourced from ClinicalTrials.gov (NCT03762616). 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.