Multiparametric Ultrasound (mpUS) as Imaging Modality for the Detection and Localization of Prostate Cancer

The current limitations in prostate cancer diagnostics, due to lack of accuracy
of the available techniques, lead to over- and undertreatment for a significant
fraction of patients with prostate cancer. Multiparametric ultrasound (mpUS),
combining different ultrasound parameters, is a new imaging modality with
potential to improve PCa detection and localisation significantly. By
correlating and comparing the parameters of mpUS of the prostate with its
carcinoma to the histology of the resected prostate we can determine the
additional clinical value of mpUS.

Primary objective: To validate mpUS as imaging modality for detection and
localization of prostate cancer by direct correlation of mpUS imaging and its
parameters with histopathology of the resected prostate.
Secondary objective: see Protocol paper, section 2. Objectives, pag 19 of 42.

Prospective, observational study

A participating patient will not benefit from this study. However, the results
of this study may benefit the diagnostic procedure for prostate cacer in the
future. There is litte burden related to study participation and the nature and
extent of the burden and risks associated with participation are considered
minimal. For the purpose of this study, there is one hospital visit necessary.
Patients need to get an intravenous canula for the contrast enhanced mode. An
intravenous canula placement is minimal invasive and without risks, however it
could be seen as a burden for some patients. During diagnosis of the prostate
cancer the patient has already experienced the usage of ultrasound ot the
prostate. It is without any risk but it can be seen as a burden for some
patients. The patient will know what to expect and would probably refuse
participation if the first ultrasound experience was unpleasent. 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%). The results of this study may be important for patients
in the future for PCa detection, localization and grading. If cancer can be
detected and localized reliable using mpUS imaging, this could have a major
impact on prostate cancer health care. In conclusion, we believe that the
burden and risk associated with participation in this study are low.