Determination of the additional clinical value of contrast enhanced ultrasound imaging for the diagnosis of prostate cancer

The sensititvity and specificity of grayscale ultrasound concerning the
diagnosis of prostate cancer is low. Based on this it is hard to interpret
anomalies seen during the ultrasound. We believe that contrast enhanced
ultrasound can improve both sensitivity and specificity. By correlating and
comparing the parameters of contrast enhanced ultrasound of the prostate with
its carcinoma to the histology of the resected prostate we can determine the
additional clinical value of contrast enhanced ultrasound.

see page 5 of the protocol: presentation of the question

observational research

Giving the patient an iv-line could be uncomfortable for the patient. However
doing the research during the hospitalization before operation means that the
patient already has an iv-line and so this will not be an extra burden for the
patient.

An ultrasound of the prostate can be experienced as uncomfortable by some
patients. However during diagnosing the prostate cancer, the patient already
had an ultrasound of the prostate at least once. So the patient will know what
to expect and would not participate when he experienced the investigation as
very unpleasent. The investigation itself will not take longer than 5 minutes.

The risk of contrast agent sonovue is minimal. Literature mentions 1 case of an
allergic reaction (0,01%). The most frequently mentioned minor side-effects of
microbubble contrast agents are alteration of taste, local pain at the
injection site and facial or general flush. These side-effects are transient,
mild and rare (1-5%).