Quantification of Contrast Enhanced Ultrasound (CEUS) in 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 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 by the Technical University in Eindhoven (TU/e) and BRACCO,
Geneva.

2.1 Primary objective:
To improve PCa detection rate with quantification, compared with subjective
CEUS interpretation and known numbers in literature.

2.2 Secondary objective:
To compare quantification results with tumour differentiation grade (Gleason
score)

2.3 Presentation of the question:
- What is the difference in, for malignancy suspicious, areas between CEUS
quantification and subjective interpretation in relation to the histological
biopsy results?
- Is there a relation between Gleason score and quantification results?
- Is there an additional value for use of CEUS quantification in clinical
practice?

This study is a prospective in-vivo study in humans in which we perform a CEUS
before taking systematic prostate biopsies. These patients are already
scheduled for biopsy because of a raised Prostate-Specific Antigen (PSA) or
abnormal Digital Rectal Examination (DRE). Afterwards a quantitative analysis
of all CEUS data will be performed.

Benefits:
Normally, if no cancer is detected by systematic biopsies, when a suspicion
for prostate cancer is still raised, the biopsies are repeated. Based on the
quantification results determined after the first systematic biopsies, in this
second session, the systematic biopsies can be optimal targeted in for
malignancy suspicious lesions. In this way, cancer detection during the
repeated biopsy session could increase.
If the results of the study show a correlation between quantification and the
biopsy results, in the future this could open the way for targeted biopsies
based on quantification techniques and therefore could decrease the number of
biopsies with a better cancer detection. Therefore, this could decrease the
burden for the patient and might improve prostate cancer treatment selection.

Risk assessment:
There is a small anticipated risk for participants. After use in thousands of
patients, adverse events 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 of general flush. In rare cases allergic reaction to
the contrast agent is described. (see 6).
Patients will be informed of the risk during intake, and it will be described
in the study information.