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Evaluation of significant Shear Wave Elastography Parameters for Prostate Biopsy and Prostate Cancer detection.
This Study will evaluate the Shear Wave Elastography (SWE) Parameters for Prostate Biopsy and Prostate Cancer detection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| suspicious for Prostate Cancer | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transrectal shear wave elastography of the prostate | Device | 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) |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Schostak, Prof. Dr. | Urologische Klinik, Otto-von-Guericke University Magdeburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology University Hospital Otto-von-Guericke-University Magdeburg | Magdeburg | Saxony-Anhalt | 39120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25599156 | Result | Correas JM, Tissier AM, Khairoune A, Vassiliu V, Mejean A, Helenon O, Memo R, Barr RG. Prostate cancer: diagnostic performance of real-time shear-wave elastography. Radiology. 2015 Apr;275(1):280-9. doi: 10.1148/radiol.14140567. Epub 2014 Nov 19. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Transrectal random biopsy of the prostate | Procedure | TRUS-SWE-guided random biopsies of the Prostata with 18G-gun |
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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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |