Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging and Biomarkers

Study Overview
=================
Brief Summary
-----------------
Prostate cancer has been the most common cancer in men in Finland over the last ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection. Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS) guided biopsy. Due to the low accuracy of TRUS, a systematic biopsy is usually performed instead of targeted TRUS biopsy. As biopsy carries a risk of increase in complications, there is an increasing interest in developing more accurate non-invasive imaging modalities. This study will enroll 150 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml and/or abnormal digital rectal examination. Multiparametric magnetic resonance imaging (mpMRI) at 3 Tesla (T) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer. Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer.

Official Title
-----------------
Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Device: 3T MRI (Magnetom Verio 3T, Erlangen, Germany)
* Device: Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 40 to 85 years Clinical suspicion of prostate cancer based on: serum level of PSA from 2,5 ng/ml to 25 ng/ml in two following measurements and/or abnormal digital rectal examination Mental status: Patients must be able to understand the meaning of the study Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff Exclusion Criteria: previous prostate biopsy in the last 6 months previous diagnosis of prostate carcinoma previous prostate surgeries, e.g. TURP (transurethral prostatic resection) symptomatic of acute prostatitis contraindications for MRI (cardiac pacemaker, intracranial clips etc) uncontrolled serious infection claustrophobia any other conditions that might compromise patients safety, based on the clinical judgment of the responsible urologist

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI<br>Comparison of targeted transrectal ultrasound guided prostate biopsies based on 3T multiparametric MRI findings to systematic non-targeted transrectal ultrasound guided prostate biopsies | Device: 3T MRI (Magnetom Verio 3T, Erlangen, Germany)<br> <br> Device: Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis | Multiparametric MRI is performed in patients with clinical suspicion of prostate cancer (elevated PSA and/or abnormal DRE). The accuracy will be determined using the results from transrectal ultrasound guided biopsies. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of molecular markers to estimate prostate cancer diagnosis. | molecular markers include PCR-analyses of multiple markers from biopsy material. The association of molecular marker status is used to estimate the risk of prostate cancer on biopsies. | 3 months |