Prostate Cancer Clinical Trial
Official title:
Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging
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.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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