Abstract
PURPOSE: Transrectal ultrasound-guided prostate biopsy (TRUS-GB) is associated with the underdiagnosis of prostate cancer, and prostate-specific membrane antigen (PSMA)-PET-targeted prostate biopsy (PSMA-TB) may reduce the misclassification of prostate cancer. The primary outcome of the study was the accuracy of the two methods in identifying clinically significant prostate cancer (csPCa). The secondary outcomes included accuracy in identifying clinically insignificant prostate cancer (GG1) and GG3 or greater tumors, cancer detection stratified by the previous biopsy status, and the detection rate of csPCa using the combination of PSMA-TB and TRUS-GB. PATIENTS AND METHODS: In this multicenter, two-arm, randomized study, biopsy-naïve patients suspected of having prostate cancer and advised to undergo prostate biopsy were randomly assigned to the PSMA-TB + TRUS-GB (combined) and TRUS-GB (control) groups. RESULTS: A total of 815 men were assessed for eligibility, and 727 men were randomly assigned to the PSMA-TB + TRUS-GB group or the TRUS-GB group. The detection rate of csPCa in the group subjected to the combination of PSMA-TB and TRUS-GB was significantly greater than that in the conventional TRUS-GB group (67.0% vs. 60.1%; P = 0.042). In the PSMA-TB + TRUS-GB group, the rate of csPCa detection by PSMA-TB was significantly greater than that by TRUS-GB (63.5% vs. 57.7%; P < 0.001), whereas the combined strategies achieved the highest detection rate (67.0% vs. 63.5%, P < 0.001; 67.0% vs. 57.7%, P < 0.001). CONCLUSIONS: The diagnostic efficacy of TRUS-GB with PSMA-TB was significantly greater than that of TRUS-GB alone. If available, PSMA-TB should be performed alongside TRUS-GB in a combined manner rather than each method alone for the most accurate pathologic results.