This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-ultrasound fusion targeted biopsy compared to cognitive registration targeted biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.
Prostate biopsy with multiple samples using a standardized template (standard biopsy, SB) under transrectal ultrasound (TRUS) guidance is the current standard diagnostic approach in suspicion of prostate cancer (PCa). However, many biopsies are unnecessary or cannot detect clinically significant PCa (csPCa). With the introduction of multiparametric magnetic resonance imaging (mpMRI) of the prostate and the improvement for PCa detection and localization, an alternative procedure, known as MRI-targeted biopsy (MRI-TB), has been shown comparable or even higher detection rates of csPCa compared to TRUS-system biopsy (SB). MRI-ultrasound fusion TB (FUS-TB) and cognitive registration TB (COG-TB) are two techniques of MRI-TB commonly used. However, the optimal methodology for targeting MRI-suspicious regions remains unknown. The accuracy of COG-TB compared with FUS-TB remains unclear. This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of COG-TB compared to FUS-TB (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
470
Cognitive registration is a visual guidance technique in which the surgeon samples a visually estimated location on ultrasound that corresponds to the MRI suspicious regions location. TRUS-system biopsy includes 12 biopsy cores.
MRI-ultrasound fusion targeted biopsy is conducted with an mpMRI-TRUS biopsy system that provides realtime fusion of TRUS images and MRI images to guide the biopsy needles. TRUS-system biopsy includes 12 biopsy cores.
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China
Detection rates of clinically significant PCa in FUS-TB and COG-TB
Time frame: When histology results available, at an expected average of 30 days post-biopsy
Detection rates of clinically insignificant PCa in FUS-TB and COG-TB
Time frame: When histology results available, at an expected average of 30 days post-biopsy
Detection rates of clinically insignificant PCa in men with MRI score 3, 4 or 5
Time frame: When histology results available, at an expected average of 30 days post-biopsy
Cancer core length of the most involved biopsy core (maximum cancer core length)
Time frame: When histology results available, at an expected average of 30 days post-biopsy
Biopsy-related adverse events
Time frame: 30 days post biopsy
Proportion of men undergoing radical prostatectomy who have Gleason grade upgrading
Time frame: 60 days post biopsy
Detection rates of clinically significant PCa in SB
Time frame: When histology results available, at an expected average of 30 days post-biopsy
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