Shear Wave Elastography of Prostate Cancer

NCT ID: NCT02425163

Last Updated: 2015-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-01-31

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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Transrectal shear wave elastography of the prostate

Intervention Type 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)

Transrectal random biopsy of the prostate

Intervention Type PROCEDURE

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

Interventions

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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)

Intervention Type DEVICE

Transrectal random biopsy of the prostate

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

Intervention Type PROCEDURE

Other Intervention Names

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SuperSonic Imagine Ultrasound System TRUS-SWE-guided random biopsies of the prostata

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.
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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University of Magdeburg

OTHER

Sponsor Role lead

Responsible Party

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Johann J. Wendler, MD

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Schostak, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Urologische Klinik, Otto-von-Guericke University Magdeburg

Locations

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

Magdeburg, Saxony-Anhalt, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 25599156 (View on PubMed)

Other Identifiers

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MD-URO-0047

Identifier Type: -

Identifier Source: org_study_id

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