An interventional study of ExactVu in Prostate Cancer, sponsored by Stanford University. Completed at 1 site in United States. Open to male participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Stanford University · Not applicable, Interventional, and Diagnostic
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 95 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
EV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of: 1. The entire prostate from posterior to anterior (may require 2 sweeps to cover base and apex) 2. The peripheral zone using the highest zoom setting (30mm depth) on the system (may require 2 sweeps to cover base and apex). Analysis of these images will be performed after surgery but before prostatectomy
Device: ExactVu
clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging
Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology
Evaluate the ability of micro-ultrasound to identify high grade prostate cancer foci (Gleason score ≥7) in comparison to final surgical pathology result (prostatectomy or biopsy)
Time frame: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days)
Prostate Cancer Border Identification Post-Prostatectomy
Evaluate the ability of micro-ultrasound to identify the borders of prostate cancer foci in comparison to final surgical pathology result in men after prostatectomy.
Time frame: 3 years
Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6)
Evaluate the ability of micro-ultrasound to detect low grade prostate cancer foci (Gleason score 6)
Time frame: 1 year and 10 months
Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison
Comparison of prostate cancer detection between micro-ultrasound and multiparametric magnetic resonance imaging (mpMRI).
Time frame: 1 year and 10 months
Measuring Correlation Between Prostatectomy Pathology and Imaging Correlation
Perform a detailed pathologic and imaging correlation between findings on micro-ultrasound, MRI and final surgical histopathology in men who undergo prostatectomy
Time frame: 3 years
| Milestone | ExactVu Imaging |
|---|---|
| Started | 95 |
| Completed | 95 |
| Not completed | 0 |
Evaluate the ability of micro-ultrasound to identify high grade prostate cancer foci (Gleason score ≥7) in comparison to final surgical pathology result (prostatectomy or biopsy)
| participants | ExactVu Imaging |
|---|---|
| Sensitivity (All Lesions) | 38 |
| Sensitivity (Excluding Anterior Lesions) | 50 |
Evaluate the ability of micro-ultrasound to identify the borders of prostate cancer foci in comparison to final surgical pathology result in men after prostatectomy.
No measurements were reported for this outcome.
Evaluate the ability of micro-ultrasound to detect low grade prostate cancer foci (Gleason score 6)
| percentage of agreement | ExactVu Imaging |
|---|---|
| Inter-Reader Agreement | 22 |
| Positive Percent Agreement for Low-Grade Cancers (Gleason Score 6) | 25.5 |
Comparison of prostate cancer detection between micro-ultrasound and multiparametric magnetic resonance imaging (mpMRI).
| percentage of agreement | ExactVu Imaging |
|---|---|
| Average Micro-Ultrasound Sensitivity | 66 ± 6.25 |
| Average mpMRI Sensitivity | 90 ± 3.97 |
| Average Micro-Ultrasound Inter-Reader Agreement (κ) | 30 ± 6.08 |
| Average mpMRI Inter-Reader Agreement (κ) | 50 ± 6.63 |
Perform a detailed pathologic and imaging correlation between findings on micro-ultrasound, MRI and final surgical histopathology in men who undergo prostatectomy
No measurements were reported for this outcome.
Collected over up to 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ExactVu Imaging | 0/95 (0%) | 0/95 (0%) | 0/95 (0%) |
| Age, Categorical(Participants) | ExactVu Imaging |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 45 |
| >=65 years | 50 |
| Sex: Female, Male(Participants) | ExactVu Imaging |
|---|---|
| Female | 0 |
| Male | 95 |
| Ethnicity (NIH/OMB)(Participants) | ExactVu Imaging |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 85 |
| Unknown or Not Reported | 5 |
| Race (NIH/OMB)(Participants) | ExactVu Imaging |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 13 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 5 |
| White | 62 |
| More than one race | 0 |
| Unknown or Not Reported | 14 |
| Region of Enrollment(participants) | ExactVu Imaging |
|---|---|
| United States | 95 |
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