Shear Wave Elastography of Prostate Cancer (ElaProC)

April 20, 2015 updated by: Johann J. Wendler, MD, University of Magdeburg
Evaluation of significant Shear Wave Elastography Parameters for Prostate Biopsy and Prostate Cancer detection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
        • Department of Urology University Hospital Otto-von-Guericke-University Magdeburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: suspicious for Prostate Cancer

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
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
Procedure: Transrectal random biopsy of the prostate
TRUS-SWE-guided random biopsies of the Prostata with 18G-gun
Other Names:
  • TRUS-SWE-guided random biopsies of the prostata

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shear wave elastography
Time Frame: 12 Months
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
Time Frame: 12 Months
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)
Time Frame: 12 Months
Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex)
12 Months
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
12 Months
Histopathological Analysis
Time Frame: 12 Months
Histopathological Analysis of biopsy specimen: benign prostate hyperplasia
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Magdeburg

Investigators

  • Principal Investigator: Martin Schostak, Prof. Dr., Urologische Klinik, Otto-von-Guericke University Magdeburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (Estimate)

April 23, 2015

Study Record Updates

Last Update Posted (Estimate)

April 23, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-URO-0047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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