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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04981223
• Other study ID #: IRB-58101
• Secondary ID: PROS0104
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Ned U Realiza
• Phone: 650-498-8496
• Email: nrealiza[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• ExactVu
clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

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