Shear Wave Elastography of Prostate Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02425163

Acronym

ElaProC

Enrollment

Registered

2015-04-23

Start date

2012-03-31

Completion date

2015-01-31

Last updated

2015-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate Cancer, Shear Wave Elastography, Prostate, Prostate Biopsy

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.

Interventions

DEVICETransrectal 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)

PROCEDURETransrectal random biopsy of the prostate

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Differentiation of Entity by Elastography	12 Months	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)	12 Months	Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex)
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
Histopathological Analysis	12 Months	Histopathological Analysis of biopsy specimen: benign prostate hyperplasia

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026