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NCT Number: NCT03013413

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

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.

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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shear Wave Elastography

Procedure

Undergo ultrasound-based elastography imaging using the Aixplorer system

Other names: Transient Elastography

ultrasound elasticity imaging

Procedure

Undergo ultrasound-based elastography imaging using the Aixplorer system

Ultrasound-Guided Prostate Biopsy

Procedure

Undergo standard of care ultrasound-guided prostate biopsy

Primary outcomes

  1. Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner

    Time frame: 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 outcomes

  1. Gleason scores of the cores detected with targeted biopsy versus those of the cores of systematic biopsy

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Registry information

Official study title

Evaluation of the Aixplorer Ultrasound System for Evaluation of the Prostate

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 6, 2017
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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