This was a retrospective observational study approved by the local institutional review board. Initially, 1203 patients who underwent systematic transrectal ultrasound (TRUS)-guided and MRI-targeted prostate biopsies in institution 1 (First Hospital of Shanxi Medical University, Taiyuan, China) between January 2018 and June 2021 were included for model development. All patients underwent evaluation for elevated serum PSA levels (4 ng/mL) or abnormal results of a digital rectal examination (DRE) or TRUS. Exclusion criteria were previous prostate biopsy, prior treatment for PCa (prostatectomy, radiotherapy, focal therapy, hormonal therapy, etc.), and incomplete data. Finally, 847 patients were enrolled for evaluation (Supplementary Fig. 1).
A total of 317 patients in the external validation cohort underwent biopsies between May 2019 and January 2022 from institution 2 (Shanxi Bethune Hospital, Taiyuan, China). The biopsy indications and exclusion criteria were the same as those for the development queue. Of the 317 patients, 208 were enrolled in cohort 2 (Supplementary Fig. 2).
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