Shear Wave Elastography of Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Device: Transrectal shear wave elastography of the prostate; Procedure: Transrectal random biopsy of the prostate

• Registration Number: NCT02425163
• Lead Sponsor: University of Magdeburg

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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-03
• Study Completion: 2015-01
• Study First Submitted: 2015-02-10
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-20
• Last Update Submitted: 2015-04-20
• Study First Posted: 2015-04-23
• Last Update Posted: 2015-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
suspicious for Prostate Cancer	Transrectal shear wave elastography of the prostate	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.
suspicious for Prostate Cancer	Transrectal random biopsy of the prostate	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.

Primary Outcome Measures

Name	Time	Method
Shear wave elastography	12 Months	transrectal shear wave elastography with detection of prostate tissue pressure \[kilo-Pascal\] in correspondence to biopsy areas

Secondary Outcome Measures

Name	Time	Method
Differentiation of Entity by Elastography	12 Months	Elasticity and location of benign (normal, benign prostate hyperplasia) or malignant tissue (Prostate Cancer)
Differentiation of Prostate cancer malignity by Elastography	12 Months	Differentiation of low-risk versus intermediate and high-risk Prostate cancer malignity (Gleason score 6 vs. 7-10) by Elastography
Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex)	12 Months	Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex)
Histopathological Analysis	12 Months	Histopathological Analysis of biopsy specimen: benign prostate hyperplasia

Trial Locations

Locations (1)

Department of Urology University Hospital Otto-von-Guericke-University Magdeburg; 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany