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

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Device: ExactVu

• Registration Number: NCT04981223
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-07-28
• Study Start: 2022-04-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-22
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

• Does not agree to consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ExactVu Imaging	ExactVu	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

Primary Outcome Measures

Name	Time	Method
Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States