Shear Wave Elastography of Prostate Cancer

Study Overview
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Brief Summary
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Evaluation of significant Shear Wave Elastography Parameters for Prostate Biopsy and Prostate Cancer detection.

Detailed Description
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This Study will evaluate the Shear Wave Elastography (SWE) Parameters for Prostate Biopsy and Prostate Cancer detection.

Official Title
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Shear Wave Elastography of Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Transrectal shear wave elastography of the prostate
* Procedure: Transrectal random biopsy of the prostate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspicious for prostate cancer with no pretreatment and Prostata specific Antigen (PSA) >4ng/ml or PSA velocity > 0.75 ng/ml per year or suspicious transrectal digital examination Status after external beam radiotherapy of the prostate in localized prostate cancer and suspicious for local prostate cancer recurrence Exclusion Criteria: None.

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: suspicious for Prostate Cancer<br>PSA >4ng/ml or PSA-Velocity >0.75ng/ml/a or suspicious rectal examination or Status after external beam therapy of the prostate in prostate cancer. Patients who are able for transrectal ultrasound examination. Transrectal shear wave elastography of the prostate for Transrectal random biopsy of the prostate. | Device: Transrectal shear wave elastography of the prostate<br>* Transrectal shear wave elastography of the prostate with SuperSonic Imagine Ultrasound System AIXPLORER and an endocavity sonic head SE12-3 (SuperSonic Imagine, Aix-en-Provence, France)<br>* Other names: SuperSonic Imagine Ultrasound System;Procedure: Transrectal random biopsy of the prostate<br>* TRUS-SWE-guided random biopsies of the Prostata with 18G-gun<br>* Other names: TRUS-SWE-guided random biopsies of the prostata;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shear wave elastography | transrectal shear wave elastography with detection of prostate tissue pressure [kilo-Pascal] in correspondence to biopsy areas | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differentiation of Entity by Elastography | Elasticity and location of benign (normal, benign prostate hyperplasia) or malignant tissue (Prostate Cancer) | 12 Months | 
| Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex) | Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex) | 12 Months | 
| Differentiation of Prostate cancer malignity by Elastography | Differentiation of low-risk versus intermediate and high-risk Prostate cancer malignity (Gleason score 6 vs. 7-10) by Elastography | 12 Months | 
| Histopathological Analysis | Histopathological Analysis of biopsy specimen: benign prostate hyperplasia | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Shear Wave Elastography, Prostate, Prostate Biopsy