The value of additional MR-Ultrasound fusion guided biopsies to standard Navigo*-based biopsies in the diagnosis of prostate cancer

In spite of the fact that we normally take 12 biopsies in patients in whom we
suspect prostate cancer, very often no tumor can be found since the majority of
the tumors cannot be visualized in grey-scale ultrasound. On MRI tumors are
more often visible and we hope to increase the number of tumors found when we
add to the standard biopsy session 1 or 2 extra biopsy in regions of interest
assigned by the radiologist. With help of image fusion we can navigate the
ultrasound guided biopsies to the ROI found on MRI. This may lead to better and
quicker diagnosis of prostate cancer, leading to reduced number of biopsy
sessions and number of biopsies per session. Furthermore there will be less
delay in definitive treatment of people who are diagnosed with prostate cancer
earlier. Possibly a more accurate Gleason grading can be obtained resulting in
more accurate work-up and leading to a more tailored treatment advise.

Primary objective
To determine whether adding the MRI/US fusion technique using mpMRI images for
directed biopsy of a ROI leads to a higher detection rate of PCa per patient
compared to a systematic 12-core biopsy protocol including directed biopsy of
ROI on grey scale TRUS images, using the 3D Navigo* system.
Secondary objective
To determine in how many patients adding the MRI/US fusion technique using
mpMRI images for directed biopsy of a ROI leads to a different Gleason score
compared to a systematic 12-core biopsy protocol including directed biopsy of
ROI on grey scale TRUS images, using the 3D Navigo* system.

Prospective in-patient blinded controlled study

There will be no intervention group, it will be an in-patient control study.

Patients will have to undergo an MRI before the biopsies. Normally, patients do
not have an MRI before biopsies, but many have one after the diagnosis prostate
cancer is made. In those cases it is only the timing that is different.
The number of biopsies in participating patients will be 13 or 14 instead of
12. We do not expect the addition of 1 or 2 biopsies to give significant extra
morbidity. On the other hand we expect that in a number of patients the tumor
will be discovered with the extra biopsy only, thus preventing a second series
of biopsies at a later stage. Overall the total number of biopsies in the whole
group could be even less than without the protocol.
Since it is an in-patient control study there*s no group bondage.