NCT02425163

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

February 10, 2015

Last Update Submit

April 20, 2015

Conditions

Prostate Cancer

Keywords

Prostate CancerShear Wave ElastographyProstateProstate Biopsy

Outcome Measures

Primary Outcomes (1)

  • Shear wave elastography

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

    12 Months

Secondary Outcomes (4)

  • Differentiation of Entity by Elastography

    12 Months

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

    12 Months

  • Differentiation of Prostate cancer malignity by Elastography

    12 Months

  • Histopathological Analysis

    12 Months

Study Arms (1)

suspicious for Prostate Cancer

ACTIVE COMPARATOR

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 prostateProcedure: Transrectal random biopsy of the prostate

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)

Also known as: SuperSonic Imagine Ultrasound System
suspicious for Prostate Cancer
Transrectal random biopsy of the prostatePROCEDURE

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

Also known as: TRUS-SWE-guided random biopsies of the prostata
suspicious for Prostate Cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25599156RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Martin Schostak, Prof. Dr.

    Urologische Klinik, Otto-von-Guericke University Magdeburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

February 10, 2015

First Posted

April 23, 2015

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

January 1, 2015

Last Updated

April 23, 2015

Record last verified: 2015-04

Locations

DE(1)