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Objectives: This study aimed to compare the effectiveness of software-based fusion-targeted biopsies (STBx) versus cognitive fusion-targeted biopsies (CogTBx) in detecting prostate cancer (PCa) and clinically significant PCa.

Materials and methods: Men aged 30-85 were included in a target trial emulation if they had undergone a STBx or CogTBx of Prostate Imaging Reporting and Data System (PI-RADS) 3-5 lesions in 2020-2024. Using log-link binary regression models with inverse probability of treatment weighting to adjust for confounding, we estimated the associations between biopsy technique and detection of PCa and clinically significant PCa (Gleason ≥3 + 4 and Gleason ≥4 + 3) by use of adjusted relative risks (aRR) with 95% confidence intervals (CIs) obtained via bootstrapping.

Results: A total of 2092 men who underwent STBx and 7933 men who underwent CogTBx in 2020-2024 were identified in PCBase Xtend. The overall proportion diagnosed with PCa was 64%. STBx detected PCa with a slightly higher frequency (aRR, 1.05; 95% CI, 1.02-1.09), corresponding to an absolute increase of 3.3 percentage points (95% CI 1.2-5.3). The relative risk for detection of Gleason ≥4 + 3 was somewhat larger (aRR, 1.13; 95% CI, 1.03-1.23). The largest relative difference for detection of PCa was observed in PI-RADS 3 lesions (aRR, 1.12; 95% CI, 1.01-1.24), and this pattern became even more apparent when the outcome was restricted to clinically significant PCa.

Conclusions: Software-based fusion-targeted biopsies detected slightly more PCa and clinically significant PCa compared to cognitive fusion-targeted biopsies, particularly in men with PI-RADS 3 lesions. Prioritizing PI-RADS 3 lesions for software-based targeted fusion biopsy could optimize diagnostic effectiveness.