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A noninferiority within-person study comparing the accuracy of transperineal to transrectal MRI–US fusion biopsy for prostate-cancer detection

Prostate Cancer & Prostatic Diseases Jan 26, 2020

Ber Y, Segal N, Tamir S, et al. - In this study, the detection rate of clinically-significant prostate-cancer (csPCa) within an index lesion between transrectal (TR) and transperineal (TP)-fusion was compared. Researchers designed a prospective, noninferiority, and within-person trial including a sum of 77 individuals for MRI–US-fusion with a discrete MRI PI-RRAD ≥ 3 lesion. They determined a dominant index lesion for each subject and sampled it by TR and TP-fusion during the same session. They randomized the order of biopsies and equipment was reset to avoid chronological and incorporation bias. Using Navigo fusion software (UC-Care, Yokneam, Israel), all biopsies were performed. They applied a noninferiority margin of 10% and a one-sided alpha level of 5%. For the detection of csPCa within MRI-visible index lesion, TP-fusion biopsies were found to be noninferior and superior to TR-fusion biopsies. When choosing biopsy method, centers experienced in both TP and TR-fusion should consider these results.
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