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

Study Overview
=================
Brief Summary
-----------------
This study will enroll 200 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml or abnormal digital rectal examination. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) 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.

Detailed Description
-----------------
Specific aims of the current study are as follows: i) To determine the sensitivity, specificity and accuracy of a novel rapid anatomical MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy ii) To determine the sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer iii) To develop statistical model for diagnosis of prostate cancer incorporating findings of a novel rapid MRI/DWI and selected biomarkers iv) To assess the applicability of TRUS guided prostate biopsy based on MRI finding in patient with no previous prostate biopsy v) To develop and validate an imaging protocol which will become the standard protocol for prostate imaging at Medical Imaging Centre of Southwest Finland (VSKK) / TYKS, Turku, Finland.

Official Title
-----------------
Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers

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

Intervention / Treatment
-----------------
* Other: Prostate MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 40 to 85 years Language spoken: Finnish 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 biopsies 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 |
| --- | --- |
| Other: MRI and biomarkers<br>Prostate MRI. Blood and urine biomarkers. Both prior to biopsy. Tissue samples during prostatectomy. | Other: Prostate MRI<br>* MRI of the prostate prior to prostate biobsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity and accuracy of MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy |  | Baseline (MRI prior to prostate biopsy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer | Serum and urine samples before prostate biopsy and tissue samples during prostatectomy | Baseline and during procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Magnetic Resonance Imaging