Shear Wave Elastography of Prostate Cancer

Prostate Cancer Clinical Trial

— ElaProC  

Official title:

Shear Wave Elastography of Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425163
• Other study ID #: MD-URO-0047
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2015
• Last updated: April 20, 2015
• Start date: March 2012
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: University of Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: January 2015
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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)

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

Locations

Country	Name	City	State
Germany	Department of Urology University Hospital Otto-von-Guericke-University Magdeburg	Magdeburg	Sachsen-Anhalt

Sponsors (1)

Lead Sponsor	Collaborator
University of Magdeburg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Correas JM, Tissier AM, Khairoune A, Vassiliu V, Méjean A, Hélénon 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shear wave elastography	transrectal shear wave elastography with detection of prostate tissue pressure [kilo-Pascal] in correspondence to biopsy areas	12 Months	No
Secondary	Differentiation of Entity by Elastography	Elasticity and location of benign (normal, benign prostate hyperplasia) or malignant tissue (Prostate Cancer)	12 Months	No
Secondary	Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex)	Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex)	12 Months	No
Secondary	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	12 Months	No
Secondary	Histopathological Analysis	Histopathological Analysis of biopsy specimen: benign prostate hyperplasia	12 Months	No