Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy

Not Applicable

Completed

• Conditions: Prostate Carcinoma
• Interventions: Procedure: Shear Wave Elastography; Procedure: Ultrasound Elasticity Imaging; Procedure: Ultrasound-Guided Prostate Biopsy

• Registration Number: NCT03013413
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Brief Summary

This clinical trial studies an ultrasound-based imaging procedure called elastography using the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. Elastography uses ultrasound imaging techniques to examine the stiffness or elasticity of a tissue and may enhance the detection of prostate cancer. It is not yet known whether elastography imaging using the Aixplorer system works better than standard ultrasound imaging in detecting prostate cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the detection of prostate cancer with elastography using the Aixplorer scanner.

SECONDARY OBJECTIVES:

I. To obtain quantitative data on the elastic properties of normal and malignant tissue in the prostate of patients referred for ultrasound guided biopsy.

II. To compare the Gleason grade of prostate cancers detected with elastography to the Gleason grade of tumors detected by conventional systematic biopsy.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 99

Inclusion Criteria

• Be scheduled for a clinically indicated biopsy of the prostate
• Agree to an ultrasound examination using the Aixplorer system
• Sign an institutional review board (IRB) approved informed consent prior to any study procedures

Exclusion Criteria

• Recent prostate biopsy within 90 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (elastography imaging using the Aixplorer system)	Ultrasound Elasticity Imaging	Patients undergo ultrasound-based elastography imaging using the Aixplorer system followed by standard of care ultrasound-guided prostate biopsy over approximately 25 minutes.
Diagnostic (elastography imaging using the Aixplorer system)	Ultrasound-Guided Prostate Biopsy	Patients undergo ultrasound-based elastography imaging using the Aixplorer system followed by standard of care ultrasound-guided prostate biopsy over approximately 25 minutes.
Diagnostic (elastography imaging using the Aixplorer system)	Shear Wave Elastography	Patients undergo ultrasound-based elastography imaging using the Aixplorer system followed by standard of care ultrasound-guided prostate biopsy over approximately 25 minutes.

Primary Outcome Measures

Name	Time	Method
Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner	At the time of prostate biopsy	Will focus on comparing the frequency of diagnosis of prostate cancer between conventional systematic biopsy and targeted biopsy based upon abnormalities in gray scale imaging, Doppler imaging, and elastography. The main parameter of interest will be the ratio of the detection frequency with targeted biopsy versus that with systematic biopsy. The analyses will be based on methods for matched data in cohort studies and will use the appropriate estimate and variance for the relative risk.

Secondary Outcome Measures

Name	Time	Method
Gleason scores of the cores detected with targeted biopsy versus those of the cores of systematic biopsy	At the time of prostate biopsy	Analyses will be carried out via the Generalized Estimating Equations methods to account for clustering within patient (multiple cores per patient).

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States