Prostate Carcinoma
Conditions
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.
Interventions
PROCEDUREShear Wave Elastography
Undergo ultrasound-based elastography imaging using the Aixplorer system
PROCEDUREUltrasound Elasticity Imaging
Undergo ultrasound-based elastography imaging using the Aixplorer system
PROCEDUREUltrasound-Guided Prostate Biopsy
Undergo standard of care ultrasound-guided prostate biopsy
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed