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

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer

• 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

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
• Primary Completion: 2024-01-26
• Results First Submitted: 2025-01-25
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Results First Posted: 2025-04-20
• Last Update Posted: 2025-04-20
• Study Completion: 2025-12

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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
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.
Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6)	1 year and 10 months	Evaluate the ability of micro-ultrasound to detect low grade prostate cancer foci (Gleason score 6)
Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison	1 year and 10 months	Comparison of prostate cancer detection between micro-ultrasound and multiparametric magnetic resonance imaging (mpMRI).
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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States