Comparison of combined MRI-TRUS fusion targeted and systematic biopsy vs systematic biopsy alone for the detection of prostate cancer in the Chinese biopsy-naïve patients: a prospective, single-center trial

Background: This study aims to compare the combined MRI-TRUS fusion targeted biopsy (TB) and systematic biopsy (SB) vs SB for the detection of prostate cancer in Chinese biopsy-naïve patients suspected of prostate cancer. Methods: This prospective study enrolled biopsy-naïve patients presenting from October 2020 to July 2024. Patients with PI-RADS scores ≥ 3 who met the inclusion criteria underwent transperineal TB combined with SB. Postoperative pathological data were collected from patients opting for radical prostatectomy at our institution. The primary outcome was the detection rate of clinically significant prostate cancer (csPCa) between combined biopsy and SB. Results: A total of 644 biopsy-naïve patients participated, with 375 diagnosed with prostate cancer. Combined biopsy detected more csPCa cases compared to SB (316(49.1%) vs 277(43.0%), Absolute Risk Difference (ARD) 6.1% (95% CI: 4.2- 7.9), p <0.001). Exploratory subgroup analyses demonstrated that combined biopsy yielded significant benefits across most subgroups, particularly in patients with PSA density >0.15 ng/mL and those with PI-RADS scores of 4–5. Among the 268 patients who underwent radical prostatectomy, the combined biopsy approach resulted in the lowest rate of postoperative pathological upgrading. Conclusions: The combination of TB and SB demonstrates superior performance compared to SB alone in detecting csPCa in Chinese patients, with marked advantages observed in specific subgroups and a significant reduction in pathological upgrading following radical prostatectomy.