N/A
Completed N=95
Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
Source: ClinicalTrials.gov NCT04981223 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology — 38; 50 participants
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.
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 |
— | — |
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. Informational only — not medical advice.