Background: Prostate biopsies are usually performed due to accidentally discovered elevated
prostate specific antigen (PSA) and/or abnormal digital rectal examination. Transrectal
ultrasound (TRUS) guided biopsy is standard procedure, but possibility for precise
documentation concerning the localization of the biopsies are lacking. Therefore, the same
locations might be subject to multiple negative biopsies. There is a growing confidence that
magnetic resonance imaging (MRI) of the prostate gland can identify significant, high-grade
tumours, and studies have shown value in performing MRI before biopsies. Because image
documentation is lacking, it is not possible to know which region actually being biopsied
with conventional TRUS biopsy. MRI and 3D ultrasound soft image fusion guided biopsy, is a
new promising method that will ascertain all regions of the prostate gland to be biopsied,
and it is possible to perform accurate targeted biopsies when combined with MRI.
Aims of the study
Compare the biopsy results in the two groups:
1. To evaluate the overall rate of positive biopsies.
2. To evaluate the rate of re-biopsies.
3. To evaluate the detection rate of Gleason grade 4 and 5 tumours.
4. To evaluate the rate of positive targeted biopsies.
5. To evaluate the rate of positive random biopsies
6. To compare targeted and random biopsies between groups.
7. To compare patient tolerance, time consumption and cost of the two methods.
8. To evaluate the diagnostic accuracy of performing cytological imprints of targeted
Material and methods: A prospective randomized study including 300 consecutive patients
referred to the initial biopsy. The patients are randomized to conventional TRUS biopsies and
image fusion guided biopsy.
All patients undergo a minimum 12-core re-biopsy procedure. In addition a targeted biopsy
will be obtained in case of positive MRI of ultrasound.