Objective: To evaluate sample quality, prostate cancer detection rate and biopsy morbidity in transrectal ultrasound (TRUS)-guided prostate biopsy (PBx) using 16- or 18-gauge Tru-Cut needles. Patients and Methods: Patients undergoing TRUS PBx were consecutively randomized with a 1:1 ratio into two study arms: group A (16-gauge needle) and group B (18-gauge needle). Core fragmentation and small specimen length (<10 mm) rate were the sample quality criteria. Three consecutive visual analog scale tests for pain and the Clavien surgical classification complications grading for rectal bleeding were used to evaluate TRUS PBx morbidity. Results: Overall, 250 patients were evaluated. No statistically significant difference between 16- and 18-gauge biopsy needles was recorded for cancer detection rate (29.6 vs. 30.4%, p = 0.890), core fragmentation rate (5 vs. 7%, p = 0.425) and shorter specimen (2 vs. 2%, p = 0.309). Pain control was similar in the two groups during the biopsy, 30 min after biopsy and the evening of the same day. Very small or absent bleeding was the more frequent complication observed in each group. Conclusion: Prostate detection rate and sample quality were not influenced by needle size. A 16-gauge needle biopsy does not increase TRUS PBx morbidity.

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