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Completed

NCT Number: NCT02425163

Shear Wave Elastography of Prostate Cancer

Evaluation of significant Shear Wave Elastography Parameters for Prostate Biopsy and Prostate Cancer detection.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Study type

Interventional

Phase

Phase 2

Primary location

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

Magdeburg, Saxony-Anhalt, 39120, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Other names: SuperSonic Imagine Ultrasound System

Transrectal random biopsy of the prostate

Procedure

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

Other names: TRUS-SWE-guided random biopsies of the prostata

Primary outcomes

  1. Shear wave elastography

    Time frame: 12 Months

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

Secondary outcomes

  1. Differentiation of Entity by Elastography

    Time frame: 12 Months

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

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

    Time frame: 12 Months

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

  3. Differentiation of Prostate cancer malignity by Elastography

    Time frame: 12 Months

    Differentiation of low-risk versus intermediate and high-risk Prostate cancer malignity (Gleason score 6 vs. 7-10) by Elastography

  4. Histopathological Analysis

    Time frame: 12 Months

    Histopathological Analysis of biopsy specimen: benign prostate hyperplasia

Sponsors and collaborators

Lead sponsor

University of Magdeburg

Other

Registry information

Acronym: ElaProC

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Apr 23, 2015
Registry last updated
Apr 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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