Evaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer

Not Applicable

Completed

Brief Summary: The purpose of the study is to evaluate the usefulness of 3-T magnetic resonance imaging (MRI) in the evaluation of suspected prostate cancer. Men with suspected prostate cancer based on serum prostate-specific antigen antigen (PSA) value are included. Men are randomized to pre-biopsy MRI or no MRI groups in ratio 1:1. Standard transrectal ultrasound guided biopsies will be taken in addition to extra biopsies from lesions suspicious based on MRI evaluation. Hypothesis is that more prostate cancers will be found after MRI evaluation.

Recruitment & Eligibility

Inclusion Criteria

Informed consent
Suspected prostate cancer based on PSA value (total PSA 2,5-10 ng/ml and PSA free to total ratio <=0.15, or total PSA 10-20 ng/ml)
PSA and serum creatinine measurement less than 60 days before transrectal ultrasound-guided prostate biopsies
No evidence of PSA increase by non-cancerous factors (catheterization, bladder stones, urinary tract infection including bacterial prostatitis)

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
MRI done	magnetic resonance imaging, Siemens	Subjects with MRI prior prostate biopsies

Primary Outcome Measures

Name	Time	Method
Number of Prostate Cancer Diagnoses in MRI and no MRI Groups	at the end of the study (up to 1 year)	The number of patients with confirmed prostate cancer among men with MRI performed before biopsies are compared to the number of patients with prostate cancer confirmed in prostate biopsies without MRI. The number patients with prostate cancer are counted as total from cancers detected in random biopsies and in biopsies targeted based on suspicious MRI findings in MRI group, and from random biopsies in no MRI group.

Secondary Outcome Measures

Name	Time	Method
Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups	at the end of the study (up to 1 year)	Number of clinically significant prostate cancers detected with and without MRI. Clinically significant prostate cancer is determined by the Gleason grading and be the number of cancer-positive biopsy cores.
Number of Positive Biopsies in MRI and no MRI Groups	at the end of the study (up to 1 year)	The number of biopsies with histology confirming prostate cancer are compared between MRI and no MRI groups. This measure will clarify if prostate cancer can be diagnosed more accurately, i.e. more biopsies with confirmed prostate cancer, after MRI. Ten or 12 biopsies will be taken from prostates below 30 grams, or equal or above 30 grams, respectively.