Shear Wave Elastography of Prostate Cancer

University of Magdeburg73 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Transrectal shear wave elastography of the prostateDEVICE

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)

Transrectal random biopsy of the prostatePROCEDURE

TRUS-SWE-guided random biopsies of the Prostata with 18G-gun

Eligibility

Medical Language ↔ Plain English

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.

Locations (1)

Department of Urology University Hospital Otto-von-Guericke-University Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Outcomes

Primary Outcomes

Shear wave elastography

transrectal shear wave elastography with detection of prostate tissue pressure \[kilo-Pascal\] in correspondence to biopsy areas

Time frame: 12 Months

Secondary Outcomes

Differentiation of Entity by Elastography

Elasticity and location of benign (normal, benign prostate hyperplasia) or malignant tissue (Prostate Cancer)

Time frame: 12 Months

Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex)

Time frame: 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

Time frame: 12 Months

Histopathological Analysis

Histopathological Analysis of biopsy specimen: benign prostate hyperplasia

Time frame: 12 Months

Data from ClinicalTrials.gov

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