Prostate Cancer Clinical Trial
Official title:
Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging Targeted Biopsies and Biomarkers (Multi-institutional Study)
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.
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