Biopsy Study Comparing MRI and Ultrasound Soft Image Fusion Guided Biopsies and Gold Standard Prostate Biopsies.

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 biopsies. 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.

Sex

Male

Inclusion criteria

* Patients without previous biopsies.
* Men aged \< 75 years, in whom it is clinically relevant to decide whether he has prostate cancer.
* PSA \> 3 - 4 ng/ml and \< 20 ng/ml.
* Suspicious findings on DRE or TRUS.
* Informed consent.

Exclusion criteria

* Patients who refuse to sign the consent form for any reason or do not accept the study premises.
* Patients who want to withdraw for any reason during the study.
* Patients with contraindications to MRI (pacemaker, claustrophobia etc.)
* Patients who have already undergone a high quality MRI examination of the prostate within the last year. In this situation the MRI examination will be evaluated together with the surgeon and radiologist on an individual basis. In case of a low quality examination, we will disregard the findings, and include the patient.

An accurate record will be kept of all the excluded patients.