Trial Information

Clinical Impact of MR Imaging in Patients With Prostate Cancer

Background:

During the last two decades, Magnetic Resonance Imaging (MRI) of the prostate has evolved to
become a promising tool in preoperative evaluation of prostate cancer. Several studies have
evaluated the radiological and histopathological correlation. However, the sensitivity and
specificity in regard to staging have shown wide ranges and poor reproducibility. These
discrepancies can be explained by difference in patient selection, MRI methods, and criteria
used for diagnosis. More studies are therefore needed to evaluate the clinical impact of
preoperative MRI in patients with prostate cancer.

Aims of the study:

To evaluate 1) if preoperative MRI can determine tumor localization, size, possible
extraprostatic extension and predict presence of Gleason grade 4 and 5 tumor, 2) the
influence of preoperative MRI on the surgical decision process with respect to the operative
procedure for removal of the gland and pelvic lymph node dissection, and 3) the impact of
preoperative MRI on the rate of positive surgical margins and functional results.

Material and method:

A prospective study including 400 consecutive patients referred to robot assisted
laparoscopic prostatectomy randomised to preoperative MRI (intervention group) and no MRI
(control group). The prostatectomy specimens will be histopathologically examined, and TNM
classification will be performed according to 2002 AJCC standard.