N/A
N=95
Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04981223 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology — 38; 50 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ExactVu (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Stanford University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology |
38; 50 | — |
| SECONDARY Prostate Cancer Border Identification Post-Prostatectomy |
— | — |
| SECONDARY Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6) |
22; 25.5 | — |
| SECONDARY Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison |
66; 90; 30; 50 | — |
| SECONDARY Measuring Correlation Between Prostatectomy Pathology and Imaging Correlation |
— | — |
Summary
The goal of this study is to use a clinical micro-ultrasound to systematically image the prostate before biopsy or surgery. The images from the ultrasound system will be saved and compared to other imaging modalities and pathology in order to develop better tools.
Eligibility Criteria
Inclusion Criteria
- Scheduled for MR-US fusion prostate biopsy or radical prostatectomy
- Agree to consent to the study
Exclusion Criteria
- Does not agree to consent.
Data sourced from ClinicalTrials.gov (NCT04981223). 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.