Mp43-11 geographic Variation of Infectious Complications Following Prostate Biopsy in the United States: Results From a Privately Insured Cohort

Abstract

objective of this study was to assess sPC detection rates of TB and TS in prospectively randomized men.METHODS: Using a noninferiority margin of 5% and a onesided alpha level of 5%, the randomization of 170 men (n[85 in each group) provides the trial with 80% power. All men underwent either TB or TS in addition to 24 systematic cores. Cancer and sPC (International Society of Urological Pathology grade group >[2) detection rates were analysed. Cancer detection rates were calculated for TS, TB, and SB at both lesion and patient level. Combination of SB þ TB or TS served as reference. The detection difference of TS and TB was estimated by the means of a generalized linear mixed (GLM) model and a t-test for independent samples. Intrapatient statistical differences in sPC detection for patient-and lesion-level were calculated using McNemar's tests with confidence intervals.RESULTS: 53 men (62%) in the TB and 69 men (81%) in the TS group harbored PC. sPC was detected in 42% of men in the TB and 67% in the TS group. SB detected 86% (in TB group) and 82% (in TS group) of men with sPC. TB detected 92% of men and 86% of lesions harboring sPC, whereas TS detected all men and 97% of sPC lesions. Comparing detection rates, TS was 8% in favor over TB (p[0.03) on patient level and 11% (p[0.04) on lesion level.CONCLUSIONS: Overall, data of this prospective randomized study demonstrate a higher sPC detection rate using a TS approach as compared to conventional TB in MRI/TRUS-fusion biopsy.