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| ID | Type | Description | Link |
|---|---|---|---|
| JT 1614 | Other Identifier | JeffTrial Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (elastography imaging using the Aixplorer system) | Experimental | Patients undergo ultrasound-based elastography imaging using the Aixplorer system followed by standard of care ultrasound-guided prostate biopsy over approximately 25 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shear Wave Elastography | Procedure | Undergo ultrasound-based elastography imaging using the Aixplorer system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner | 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. | At the time of prostate biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Gleason scores of the cores detected with targeted biopsy versus those of the cores of systematic biopsy | Analyses will be carried out via the Generalized Estimating Equations methods to account for clustering within patient (multiple cores per patient). | At the time of prostate biopsy |
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Inclusion Criteria:
Exclusion Criteria:
• Recent prostate biopsy within 90 days
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| Name | Affiliation | Role |
|---|---|---|
| Ethan Halpern, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Sidney Kimmel Cancer Center | View source |
| Thomas Jefferson University Hospital | View source |
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|
| 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 |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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