MRI and Biomarkers in Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Prostate cancer has been the most common neoplastic disease 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. Because of the low accuracy of TRUS a systematic biopsy is usually performed instead of targeted TRUS biopsy. As biopsy carries a significant risk of complications, there is an increasing interest in developing more accurate non-invasive imaging modalities. This prospective multi-institutional study will enroll 400 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. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 1.5/3 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 Targeted Biopsies and Biomarkers (Multi-institutional Study)

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

Intervention / Treatment
-----------------
* Procedure: prostate biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18 to 85 years Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to 20 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 within 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 hip replacement surgery or other metal implants in the pelvic area

Ages Eligible for Study
-----------------
Minimum Age: 18 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 guided prostate biopsy<br>prostate biopsy after MR-imaging | Procedure: prostate biopsy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of biparametric MRI (T2wi+DWI) in prostate cancer diagnosis | Biparametric MRI (T2wi+DWI) is performed in patients with a clinical suspicion of prostate cancer (elevated PSA and/or abnormal DRE). The accuracy will be determined using the results from transrectal ultrasound guided biopsies. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis | Accuracy of selected tissue, urine, and blood biomarkers for prostate cancer diagnosis will be evaluated. Gene expression profile of selected genes will be compared between cancer and non-cancer cases to investage optimal gene expression panels for prostate cancer risk prediction. Similarly serum and urine marker profiles are compared between cancer and non-cancer cases | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, PSA, MRI, biopsy, biomarker