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Trial Outcomes & Findings for Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging (NCT NCT04981223)

NCT ID: NCT04981223

Last Updated: 2026-05-28

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

95 participants

Primary outcome timeframe

From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days)

Results posted on

2026-05-28

Participant Flow

Participant milestones

Participant milestones
Measure
ExactVu Imaging
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 ExactVu: clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging
Overall Study
STARTED
95
Overall Study
COMPLETED
95
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
ExactVu Imaging
n=95 Participants
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 ExactVu: clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging
Age, Categorical
<=18 years
0 Participants
n=51 Participants
Age, Categorical
Between 18 and 65 years
45 Participants
n=51 Participants
Age, Categorical
>=65 years
50 Participants
n=51 Participants
Sex: Female, Male
Female
0 Participants
n=51 Participants
Sex: Female, Male
Male
95 Participants
n=51 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
n=51 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
85 Participants
n=51 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants
n=51 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=51 Participants
Race (NIH/OMB)
Asian
13 Participants
n=51 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=51 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=51 Participants
Race (NIH/OMB)
White
62 Participants
n=51 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=51 Participants
Race (NIH/OMB)
Unknown or Not Reported
14 Participants
n=51 Participants
Region of Enrollment
United States
95 participants
n=51 Participants

PRIMARY outcome

Timeframe: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days)

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)

Outcome measures

Outcome measures
Measure
ExactVu Imaging
n=57 Participants
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 ExactVu: clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging
Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology
Sensitivity (All Lesions)
38 participants
Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology
Sensitivity (Excluding Anterior Lesions)
50 participants

SECONDARY outcome

Timeframe: 3 years

Population: No participants were analyzed for this outcome. The slide scanning platform was deprecated during the study period, and specimens were collected during the transition between platforms. As a result, slides were not digitized and tumor border correlation with imaging could not be performed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year and 10 months

Evaluate the ability of micro-ultrasound to detect low grade prostate cancer foci (Gleason score 6)

Outcome measures

Outcome measures
Measure
ExactVu Imaging
n=57 Participants
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 ExactVu: clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging
Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6)
Inter-Reader Agreement
22 percentage of agreement
Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6)
Positive Percent Agreement for Low-Grade Cancers (Gleason Score 6)
25.5 percentage of agreement

SECONDARY outcome

Timeframe: 1 year and 10 months

Population: This analysis includes all participants evaluated for prostate cancer detection using micro-ultrasound (MUS) and multiparametric MRI (mpMRI). Metrics include sensitivity and inter-reader agreement (κ values), reported as percentages for consistency

Comparison of prostate cancer detection between micro-ultrasound and multiparametric magnetic resonance imaging (mpMRI).

Outcome measures

Outcome measures
Measure
ExactVu Imaging
n=57 Participants
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 ExactVu: clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging
Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison
Average Micro-Ultrasound Sensitivity
66 percentage of agreement
Standard Error 6.25
Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison
Average mpMRI Sensitivity
90 percentage of agreement
Standard Error 3.97
Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison
Average Micro-Ultrasound Inter-Reader Agreement (κ)
30 percentage of agreement
Standard Error 6.08
Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison
Average mpMRI Inter-Reader Agreement (κ)
50 percentage of agreement
Standard Error 6.63

SECONDARY outcome

Timeframe: 3 years

Population: No participants were analyzed for this outcome. The slide scanning platform was deprecated during the study period, and specimens were collected during the transition between platforms. As a result, slides were not digitized and imaging-pathology correlation could not be performed.

Perform a detailed pathologic and imaging correlation between findings on micro-ultrasound, MRI and final surgical histopathology in men who undergo prostatectomy

Outcome measures

Outcome data not reported

Adverse Events

ExactVu Imaging

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Geoffrey Sonn

Stanford University

Phone: (650) 498-6000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place