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

NCT04981223 | Active Not Recruiting Results DMC FDA Device

• 2 other identifiers: IRB-58101NCI-2022-05158
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

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

Secondary Outcomes (4)

• Prostate Cancer Border Identification Post-Prostatectomy

  3 years

• Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6)

  1 year and 10 months

• Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison

  1 year and 10 months

• Measuring Correlation Between Prostatectomy Pathology and Imaging Correlation

  3 years

Study Arms (1)

ExactVu Imaging

EXPERIMENTAL

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

Interventions

ExactVu DEVICE

clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging

ExactVu Imaging

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for MR-US fusion prostate biopsy or radical prostatectomy
• Agree to consent to the study

You may not qualify if:

• Does not agree to consent.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 95304, United States

Location

Related Publications (1)

• Zhou SR, Choi MH, Vesal S, Kinnaird A, Brisbane WG, Lughezzani G, Maffei D, Fasulo V, Albers P, Zhang L, Kornberg Z, Fan RE, Shao W, Rusu M, Sonn GA. Inter-reader Agreement for Prostate Cancer Detection Using Micro-ultrasound: A Multi-institutional Study. Eur Urol Open Sci. 2024 Jul 13;66:93-100. doi: 10.1016/j.euros.2024.06.017. eCollection 2024 Aug.

  PMID: 39076245 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Geoffrey Sonn
• Organization: Stanford University

gsonn@stanford.edu

(650) 498-6000

Study Officials

• Geoffrey Sonn

  Stanford Universiy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 28, 2021
• Study Start: April 1, 2022
• Primary Completion: January 26, 2024
• Study Completion: December 1, 2025
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)