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

May 5, 2026 updated by: Geoffrey Sonn, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 95304
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: ExactVu
clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology
Time Frame: 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)
From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate Cancer Border Identification Post-Prostatectomy
Time Frame: 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.
3 years
Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6)
Time Frame: 1 year and 10 months
Evaluate the ability of micro-ultrasound to detect low grade prostate cancer foci (Gleason score 6)
1 year and 10 months
Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison
Time Frame: 1 year and 10 months
Comparison of prostate cancer detection between micro-ultrasound and multiparametric magnetic resonance imaging (mpMRI).
1 year and 10 months
Measuring Correlation Between Prostatectomy Pathology and Imaging Correlation
Time Frame: 3 years
Perform a detailed pathologic and imaging correlation between findings on micro-ultrasound, MRI and final surgical histopathology in men who undergo prostatectomy
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Geoffrey Sonn, Stanford Universiy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

January 26, 2024

Study Completion (Actual)

January 26, 2024

Study Registration Dates

First Submitted

July 9, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-58101
  • NCI-2022-05158 (Registry Identifier: National Cancer Institute: Clinical Trials Reporting Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe