Clinical value of intraoperative frozen section examination-assisted strategy in prostate biopsy: a comparative study of diagnostic efficiency and clinical practicality

OBJECTIVE: Performing targeted biopsy (TB) first, followed by intraoperative frozen section examination (IFSE), and omitting systematic biopsy (SB) when prostate cancer is detected may reduce the number of unnecessary biopsy cores from SB while maintaining an equivalent prostate cancer detection rate. METHODS: Patients scheduled for mpMRI/TRUS fusion biopsy due to a PIRADS score ≥ 4 were prospectively enrolled between October 2023 and November 2025. Patients were randomly assigned to a control group (TB + SB) or an observation group using a random number table. In the observation group, TB was performed first, and the obtained specimens were immediately subjected to IFSE. If the result was positive, no further cores were taken; if negative, SB was subsequently performed. The positive detection rate, complication rates, and post-radical prostatectomy (RARP) pathological findings were compared between the two groups. RESULTS: A total of 195 and 187 patients were included in the control and observation groups, respectively. The overall positive biopsy rate was 80.51% (157/195) in the control group and 78.61% (147/187) in the observation group, with no significant statistical difference (P = 0.645). The clinically significant prostate cancer (csPCa) detection rates were 67.69% (132/195) and 69.52% (130/187) in the control and observation groups, respectively, showing no significant difference (P = 0.701). The mean number of biopsy cores was 23.89 ± 6.42 in the control group and 8.27 ± 8.90 in the observation group, which was significantly lower than the control group (P < 0.001). In the observation group, 50 patients (26.74%) underwent immediate additional SB, and 10 (5.35%) had Routine pathology positive for prostate cancer, including 5 with csPCa. The mean time to obtain the final pathology report was 0.025 (0.023,4) days in the observation group, significantly shorter than the 4 (4,5) days in the control group (P < 0.001). The VAS pain score was also significantly lower in the observation group compared to the control group (2.52 ± 1.52 vs. 2.91 ± 1.59, P = 0.014). Among patients who subsequently underwent RARP, there were no significant differences between the control and observation groups in terms of pathological upgrading/downgrading (44.19% vs. 38.24%) or positive surgical margin rates (25.58% vs. 23.53%) (all P > 0.05). CONCLUSION: For patients with suspected prostate cancer, the novel biopsy model based on IFSE may be a feasible option. It can maintain a comparable prostate cancer detection rate while significantly reducing the number of biopsy cores, and shows no oncological disadvantage at the time of RARP.