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Brief Title: Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers
Official Title: Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers
Study ID: NCT02844829
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.
Minimum Age: 40 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Department of Urology, Turku University Hospital, Turku, Western Finland Province, Finland
Name: Hannu J Aronen, M.D. Ph.D.
Affiliation: Diagnostic radiology University of Turku
Role: PRINCIPAL_INVESTIGATOR