†These authors contributed equally.
Background: Prostate cancer is one of the most common cancers affecting men worldwide with an increasing incidence in most countries. The gold standard for diagnosis is Transrectal Ultrasonography-guided prostate biopsy. The quality of the biopsy is determined by parameters like the length of the biopsy core and the degree of fragmentation, affecting detection rate. SmartBx™ is a tool designed for the handling of prostate biopsy specimens and is intended for maximal tissue preservation. The aim of the current study was to evaluate the detection rate of prostate cancer using the new SmartBx™ tool. Patients and Methods: The study group had a biopsy using the SmartBx™ system and each biopsy core was applied into a cassette, which included two cores of biopsies which were then downloaded into a formalin-filled container. The control group included patients who underwent a Transrectal Ultrasonography-guided biopsy using the “standard” technique of biopsy collection. Data were collected prospectively in the study group, and retrospectively in the control group. Overall detection rate, and detection rate per core, were calculated and compared between the two groups. Results: The study included 600 patients, 300 in each group. There were no statistically significant differences between the groups regarding baseline characteristics. The average core numbers obtained per patient were 13.0 ± 2.7 and 14.1 ± 4.4 (P = 0.001) in the SmartBx™ and control groups, respectively. The use of the SmartBx™ system resulted in 21.2% better tissue preservation than in the control group. The overall detection rate as well as the detection rate per core were higher in the study group. More Gleason score 4 + 3 (Grade Group III) were detected in the study group (44.1% vs. 12.5%, P = 0.01). Conclusions: The use of the SmartBx™ system yielded more biopsy tissue for diagnosis. It increased the detection rate per core and the detection of Gleason score 4 + 3 (Grade Group III) prostate cancer.