Prostate Cancer Clinical Trial
Official title:
MR-target Biopsy vs. TRUS-biopsy in Men With Suspicious Prostate Cancer: A Paired Cohort Study
This paired cohort blinded trial aims to assess the detection rate of clinically significant
cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with
clinical suspicion of prostate cancer who have had no prior prostate biopsy. The
investigators hypothesize that additional MRI-targeted biopsy will detect more clinically
significant cancers than standard TRUS biopsy.
Main objective: To compare MR-target vs. standard 12-cores TRUS-biopsy for the diagnosis of
clinically significant prostate cancer.
Before prostate biopsy, all patients be preceded by mpMRI. The mpMRI is read by an
experienced radiologist according to the PI-RADS version 2 scoring system. PI-RADS scoring
system is used to assign a degree of doubt prostate cancer. Depending on the PI-RADS score,
MR targeted biopsy is determined.
1. MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be
performed. MR targeted biopsy would be performed by radiologist.
2. Next conventional ultrasound-guided 12-core systematic biopsy would be performed by
urologist. This portion will be performed without information of the MRI report.
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