Prostate Cancer Clinical Trial
Official title:
Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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