Value of multiparametric MR and MRI-guided biopsies of the prostate in men with an elevated PSA

Prostate cancer is the most common malignancy in men in the Netherlands. In
2009, 10,166 new cases were seen with a mortality of 2,492. With an increasing
incidence, a growing economic burden presses the community. Furthermore, PSA
testing is not specific and subsequent transrectal ultrasound (TRUS) biopsy
result in over-diagnosis, and subsequent over-treatment. It has been shown that
MRI and MRI-guided biopsy are accurate in localizing aggressive cancer in
selected patient populations. We expect that MRI may also be of additional
value in detecting significant cancers in men with an elevated PSA. If so. it
will result in a more accurate therapy choice (reduction of over-treatment)
with subsequent lower morbidity and lower costs. However, empirical evidence is
lacking.

To investigate the additional value of MRI and MRI-guided biopsy in men with an
elevated PSA in the general practitioners* (GP) practice regarding the
detection of both insignificant and significant cancer, and reduced biopsies.

Clincial trial with a follow-up of 12 months.

All men will undergo an MRI-scan. If suspicious lesions are present, also
MRI-guided biopsies will be taken. If no abnormalities are seen, no MR-guided
biopsies will be performed. Afterwards, all men will undergo regular
TRUS-guided biopsies.

MR imaging may cause some discomfort, such as feelings of claustrophobia and
discomfort due to loud sounds of the MR instrument during the study. Patients
are screened for prior claustrophobic symptoms using a screening form, which is
also used to search for metal device and foreign bodies. Some patients will
undergo biopsies both with MRI and TRUS, which causes inconvenience and takes
more time.