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Shear Wave Elastography of Prostate Cancer (ElaProC)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Transrectal shear wave elastography of the prostate
Transrectal random biopsy of the prostate
Sponsored by
University of Magdeburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, Shear Wave Elastography, Prostate, Prostate Biopsy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

suspicious for Prostate Cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Differentiation of Entity by Elastography
Elasticity and location of benign (normal, benign prostate hyperplasia) or malignant tissue (Prostate Cancer)
Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex)
Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex)
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
Histopathological Analysis
Histopathological Analysis of biopsy specimen: benign prostate hyperplasia

Full Information

First Posted
February 10, 2015
Last Updated
April 20, 2015
Sponsor
University of Magdeburg
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1. Study Identification

Unique Protocol Identification Number
NCT02425163
Brief Title
Shear Wave Elastography of Prostate Cancer
Acronym
ElaProC
Official Title
Shear Wave Elastography of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Magdeburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of significant Shear Wave Elastography Parameters for Prostate Biopsy and Prostate Cancer detection.
Detailed Description
This Study will evaluate the Shear Wave Elastography (SWE) Parameters for Prostate Biopsy and Prostate Cancer detection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Shear Wave Elastography, Prostate, Prostate Biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
suspicious for Prostate Cancer
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transrectal shear wave elastography of the prostate
Other Intervention Name(s)
SuperSonic Imagine Ultrasound System
Intervention Description
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
Procedure
Intervention Name(s)
Transrectal random biopsy of the prostate
Other Intervention Name(s)
TRUS-SWE-guided random biopsies of the prostata
Intervention Description
TRUS-SWE-guided random biopsies of the Prostata with 18G-gun
Primary Outcome Measure Information:
Title
Shear wave elastography
Description
transrectal shear wave elastography with detection of prostate tissue pressure [kilo-Pascal] in correspondence to biopsy areas
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Differentiation of Entity by Elastography
Description
Elasticity and location of benign (normal, benign prostate hyperplasia) or malignant tissue (Prostate Cancer)
Time Frame
12 Months
Title
Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex)
Description
Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex)
Time Frame
12 Months
Title
Differentiation of Prostate cancer malignity by Elastography
Description
Differentiation of low-risk versus intermediate and high-risk Prostate cancer malignity (Gleason score 6 vs. 7-10) by Elastography
Time Frame
12 Months
Title
Histopathological Analysis
Description
Histopathological Analysis of biopsy specimen: benign prostate hyperplasia
Time Frame
12 Months

10. Eligibility

Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Schostak, Prof. Dr.
Organizational Affiliation
Urologische Klinik, Otto-von-Guericke University Magdeburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology University Hospital Otto-von-Guericke-University Magdeburg
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25599156
Citation
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.
Results Reference
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Shear Wave Elastography of Prostate Cancer

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