Objective  To investigate the ability of separate and combined biopsy methods to distinguish clinically significant prostate cancer (csPCa) from clinically insignificant prostate cancer (incsPCa), we assessed diagnostic positive rates for patients undergoing transperineal prostate systematic biopsy (SB), cognitive fusion targeted biopsy (CF-TB), and combined biopsy (CB) (i.e. SB combined with CF-TB) under intravenous anesthesia.

  Methods  We analyzed clinical data from 151 patients with prostate-specific antigen (PSA) ≤50 ng/mL undergoing their first prostate biopsy in Cancer Hospital of Huanxing Chaoyang District Beijing and National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College from January 2019 to November 2021. The 3.0 Tesla standard prostate multi-parametric magnetic resonance imaging (mpMRI) examinations found 161 lesions with prostate imaging reporting and data system （PI-RADS) scores ≥3. With patients under intravenous anesthesia and indwelling catheter, 2-4 needle CF-TB biopsies were performed using transperineal ultrasound guidance, followed by 12 needle SB. Patients who underwent SB, CF-TB, and CB were each analyzed by stratification for their respective csPCa and incsPCa detection rates, age, PSA, CF-TB needle count, PI-RADS score, and digital rectal examination results.

  Results  The median PSA value for all patients was 11.50 (0.52-49.37 ng/mL). In total, 161 lesions with PI-RADS score ≥ 3 points were found. All 151 patients received 12 needles of SB, while 47, 52, and 52 patients received 2, 3, and 4 needles of CF-TB, respectively. The respective positivity rates of SB, CF-TB and CB in diagnosing csPCa were 54.3% (82/151), 53.0% (80/151) and 58.9%(89/151). Statistical results indicate that the difference in positivity rate between CB and SB is significant (P=0.016) as is the difference between CB and CF-TB positivity rates (P=0.004). The respective positivity rates of SB, CF-TB, and CB in diagnosing incsPCa were 7.9%(12/151)、9.3%(14/151), and 11.3%(17/151). The positivity rate of CB was not significantly different than that of SB or CF-TB (all P > 0.05). Stratification plane analysis with age, PSA value, number of CF-TB needles, PI-RADS score, and digital rectal examination results showed that the 2-needle CF-TB scheme was inferior to CB in diagnosing csPCa (P=0.031). There was no significant difference in the csPCa positivity rates of 3-needle and 4-needle CF-TB relative to CB.

  Conclusions  CB achieves a higher csPCa diagnosis rate without increasing detection of incsPCa under transperineal ultrasound guidance. CF-TB with 3-needles per lesion was highly effective in diagnosing csPCa.