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Clinical Trials/NCT04981223
NCT04981223
Active, not recruiting
Not Applicable

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

Stanford University1 site in 1 country100 target enrollmentApril 1, 2022
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Stanford University
Enrollment
100
Locations
1
Primary Endpoint
Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
December 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Geoffrey Sonn

Associate Professor of Urology

Stanford University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • 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 Sites (1)

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