A European, Multi-Centre Study to Evaluate the Value of Real-Time Elastography in the Diagnosis of Prostate Carcinoma

Elastography is an ultrasound imaging technique based on the concept that
significant differences exist between elastic properties of benign and
malignant tissue. It is able to detect the change in reflection of sound waves
when manual compression is applied to the tissue.

In 2010 Aigner et al. compared elastography guided biopsies with 10 core
systematic biopsies in 94 men with a low PSA (mean 3.2 ng/ml, range 1.3 to
4.0). PCa was found in 27 patients (28.7%). They showed that the detection rate
of PCa per patient was comparable, in the elastography guided (21.3%) and in
the systematic biopsies(19.1%). n the elastography group a sensitivity of 74%
and specificity of 60% was found per patient. However with elastography
significantly less biopsies were taken (158 versus 752).
In 2011 Kapoor et al. performed a similar study in 50 patients with a high PSA
(mean 12.6 ng/ml, range 9.8 to 14.4) 5. PCa was found in 12 patients (24%). Per
patient the sensitivity and specificity were 91.7% and 86.8% respectively. Per
core sensitivity and specificity were 72.5% and 100% respectively.

The unicentric studies carried out so far have shown it is possible to view a
significantly larger number of prostate carcinoma foci by conducting
elastography guided biopsies when compared with TRUS-controlled biopsies.
Furthermore, the increase in the detection rate of PCA cases thanks to the use
of elastography guided biopsies was also demonstrated.

The objective of this study is to record and evaluate an elastography guided
biopsy used in routine clinical procedure and to validate its value with
respect to improved prostate carcinoma visualisation and detection.

The intention is to represent the benefits of this method in terms of an
increased hit rate when compared with a randomised "blind" biopsy. For this
purpose, biopsies taken under conventional conditions using transrectal
ultrasonography will be compared with biopsies which have been obtained using
the elastography method. The aim is to identify to what extent real-time
elastography can not only achieve an in-creased hit rate but also a more
precise tumour classification (tumour stage, aggres-siveness of the tumour).
If it is the case that, due to a diagnosed prostate carcinoma, the prostate
must be removed, then the results from the biopsy will be compared with the
histopathological examination of the specimen.

Hypothesis:
It is assumed that the use of an elastography-controlled biopsy will result in
at least a 5% increase in the diagnosis of prostate carcinomas. This method
should detect more prostate carcinomas than TRUS-controlled biopsies.

The patient has voluntarily opted to have a biopsy.
* During the course of the meeting with the physician, the patient will provide
their consent to participate in the evaluation study (see participant
information and consent).
* The examination will take place blinded and will be carried out by two
examiners. First of all, examiner 1 will proceed with the elastography. and
then leave the room.
* Examiner 2 then comes in and proceeds with the conventional ultrasound and
consecutively the randomised 12 x biopsies.
* Then examiner 1 wil come in again and will perform the targeted sampling
under elastography conditions.
* The elastography guided biopsy includes 4 biopsies: In each case, these are
two biopsies from the two most conspicuous elastography areas.

Ultrasound is considered a safe diagnostic tool because of the use of
non-ionizing radiation.

The risk of side-effects is not increased compared to the standars biopsies
which the patient undergoes for routine clinical diagnosis next to this study.