[Diagnostic performance analysis of targeted biopsy versus combined targeted and systematic biopsy in patients with...

Objective: To evaluate the prostate cancer (PCa) detection rates of targeted biopsy (TB) alone versus TB combined with systematic biopsy (SB) in patients with prostate imaging reporting and data systemv2.1 (PI-RADS v2.1) 4-5 lesions on biparametric magnetic resonance imaging. Methods: Clinical data were retrospectively collected from 1 060 patients who underwent combined prostate TB and SB at the First Affiliated Hospital of Nanjing Medical University between March 2018 and December 2023. All patients had pre-biopsy biparametric magnetic resonance imaging with PI-RADS v2.1 category 4 or 5 lesions. A comparative analysis was performed to evaluate the PCa detection rate and clinically significant prostate cancer (csPCa) detection rate between the two biopsy strategies. Using the postoperative pathological findings from 730 patients who underwent radical prostatectomy as the reference standard, a comparison of the pathological upgrading rates between TB alone and the combined biopsy approach was performed. Results: TB alone yielded detection rates of 79.6% (844/1 060) for PCa and 67.9% (720/1 060) for csPCa. The combined biopsy approach yielded detection rates of 82.2% (871/1 060) for PCa and 69.7% (739/1 060) for csPCa. The two strategies demonstrated no significant difference in detection rates of PCa and csPCa (P=0.136 and P=0.373) and showed substantial agreement (Kappa=0.918 for PCa and 0.958 for csPCa, both P＜0.001). This diagnostic alignment persisted across subgroups: among patients with PI-RADS category 4 lesions, the csPCa detection rates for TB alone and combined biopsy were 59.2% (395/667) and 61.5% (410/667), respectively, demonstrating high concordance (Kappa=0.953, P＜0.001). Among patients with PI-RADS category 5 lesions, the csPCa detection rates for TB alone and combined biopsy were 82.7% (325/393) and 83.7% (329/393), respectively, also demonstrating a high level of agreement (Kappa=0.964, P＜0.001). When compared with postoperative pathology, the overall pathological upgrading rates were 30.5% (223/730) for TB alone and 25.9% (189/730) for combined biopsy. The rates of upgrading specifically from biopsy-negative or ciPCa to csPCa were 12.3% (90/730) and 9.9% (72/730), respectively. Conclusion: For patients with PI-RADS 4-5 lesions, TB may serve as a clinically equivalent alternative to combined biopsy, achieving comparable diagnostic efficacy while reducing procedural burden on both patients and healthcare systems.