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

Last Updated: 2025-04-20

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

ACTIVE_NOT_RECRUITING

Study phase

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

2025-04-20

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=93 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=93 Participants
Age, Categorical >=65 years	50 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	95 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	85 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	13 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants
Race (NIH/OMB) White	62 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=93 Participants
Region of Enrollment United States	95 participants n=93 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

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) Positive Percent Agreement for Low-Grade Cancers (Gleason Score 6)	25.5 percentage of agreement
Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6) Inter-Reader Agreement	22 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

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

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place