This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of mpMRI-targeted biopsy compared to transperineal standard 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 (TB), has been shown comparable or even higher detection rates of csPCa compared to TRUS-biopsy (SB). This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of TB compared to SB (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
400
MRI-guided targeted prostate biopsy
Transperineal ultrasound guided prostate biopsy(SB).
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China
RECRUITINGDetection rates of clinically significant PCa
Clinically significant prostate cancer is considered as: biopsy Gleason score ≥3+4 or maximum cancer core length ≥5 mm.
Time frame: 30 days post biopsy
Detection rates of clinically insignificant PCa
Clinically insignificant prostate cancer is considered as: biopsy Gleason score \<3+4 and maximum cancer core length \<5 mm.
Time frame: 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
Comparing the Gleason grades (from 1-5, the bigger the worse) between biopsy and final pathology, Gleason grade is upgrading when the Gleason grade of final pathology is bigger than that of biopsy.
Time frame: 90 days post-biopsy
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