ProMES study (prostate biopsies using MR-Ultrasound fusion study).

Prostate cancer (PCa) is the most commons cancer among men over 40 years. Standard diagnostics for men

suspected to have prostate cancer encompass 10-12 ultrasound-guided random biopsies of the prostate in a fixed

manner. This method is known to have several shortcomings such as detection of clinically insignificant cancers, falsenegative

results and the need for repeated biopsies in case of negative results. Multi-parametric magnetic resonance

imaging (MP-MRI) of the prostate is an evolving imaging method that allows accurate visualization of prostate cancer.

By fusing these images with transrectal ultrasound images, targeted biopsies can be performed. These MRI-ultrasound

fusion biopsies are reported to diagnose more clinically relevant prostate cancers (with a higher Gleason score).

Therefore MRI-ultrasound fusion biopsies have the potential to reduce overtreatment of patients.

This study aims to make a full comparison between random biopsies versus MRI-ultrasound

targeted biopsies in respect of inclusion for Active Surveillance but also number of prostate cancers

diagnosed. We will perform a observational diagnostic study in which two different methods for taking prostate biopsies within the

same patient will be compared, namely standardized ultrasound guided biopsies and MRI-ultrasound fusion biopsies.

MRI-ultrasound fusion biopsies of the prostate will detect more clinically relevant tumours (I.e. higher Gleason score) when compared to random ultrasound-guided biopsies in the primary prostate biopsy setting.

1. Intake and informed consent

2. mpMRI of the prostate

3. Prostate biopsies

4. Revision and therapy decision making. After the biopsies, patients will receive standard of care depending on pathology results and are no longer part of the study.

We will perform a observational diagnostic study in which two different methods for taking prostate biopsies within the
same patient will be compared, namely standardized ultrasound guided biopsies and MRI-ultrasound fusion biopsies.
Patients will undergo 10 standardized ultrasound guided biopsies, 5 biopsies on each side.

After this, the mpMRI will be fused with the ultrasound images so that two additional biopsies can be taken from the ROI.
If no ROI is drawn by the radiologist two random additional biopsies will be taken.
If two or more ROI’s are drawn, a maximum of 4 additional biopsies is taken from the two regions with the highest Gleason score.
MRI-ultrasound fusion biopsies and random biopsies will be taken in the same session without removal of
the rectal probe.