CEUS targeted biopsies compared to mpMRI targeted and systematic biopsies for the detection of Prostate Cancer.

With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can
be visualised with the potential to improve ultrasound imaging for prostate
cancer (PCa) detection and localisation significantly. The past years numerous
studies have been performed with CEUS, all basing their results on subjective
judgement of the investigator. CEUS image interpretation is difficult and
requires a well-trained expert. To overcome these difficulties CEUS
quantification techniques can be of use. The techniques used in this protocol
have been developed in cooperation with the Eindhoven University of Technology
(TU/e).

Primary objective:

To compare the cancer detection rate of CEUS targeted biopsies with the cancer
detection rate of mpMRI targeted and systematic biopsies.

Secondary objective:

To characterize the tumors detected by the different biopsy schemes in terms of
Gleason score.

This study is a prospective in-vivo study in human patients. These patients are
scheduled for prostate biopsy with systematic biopsies and mpMRI targeted
biopsies as standard of care due to elevated serum Prostate Specific Antigen
(PSA) and/or abnormal digital rectal examination (DRE). For the purpose of this
study, patients will undergo a CEUS imaging procedure through an additional
infusion of a contrast agent next to the mpMRI imaging procedure. During the
biopsy session, for the purpose of this study a maximum of 4 targeted CEUS
biopsies will be taken from a max of 2 CEUS suspicious lesions by an
experienced investigator blinded to mpMRI results and next to the mpMRI
targeted biopsies and systematic biopsies. Afterwards the cancer detection rate
and tumor differentiation grade of targeted biopsies will be compared with
those of the systematic biopsies.

Benefits

Normally, if no cancer is detected by systematic biopsies and the suspicion for
prostate cancer persists, biopsies are repeated. If cancer missed by these
systematic biopsies is detected using CEUS dispersion imaging targeted biopsies
the patients would benefit from it. Furthermore, an improved determination of
the Gleason score by targeted biopsies might improve the selection of prostate
cancer treatment.
If this study is successful in the future all patients undergoing biopsies will
benefit from these results.


Risk assessment

There is a small anticipated risk for participants. After use in thousands of
patients, adverse events to the ultrasound contrast agent appear to be
transient, mild and rare. The side effects mostly consist of transient
alteration of taste, local pain at the injection site and facial or general
flush. In rare cases allergic reaction to the contrast agent is described.
Patients will be informed of the risk during intake, and it will be described
in the study information.