Introduction: Current guidelines recommend an additional systematic biopsy (SB) to complement MRI-targeted biopsy (TB) in order to address the limited sensitivity of TB alone. SB may be beneficial for diagnosing additional significant PCa (sPCa) but also harmful in terms of additional non-significant PCa (nsPCa). This study aimed to investigate selection criteria to identify men who might benefit from SB within this clinically relevant trade-off.
Methods: A retrospective single-centre cohort of 1043 men underwent MRI-ultrasound fusion transperineal synchronous TB and SB according to the Ginsburg scheme with the ISR´obot Mona Lisa biobot between 10/2015 – 05/2020. The median number of cores was 36 (range: 12-70). Univariate and multivariate logistic regression models were applied to identify predictors for the additional diagnosis of sPCa (ISUP 2 and higher) and insignificant PCa (ISUP 1).
Results: The mean age and PSA were 67 ± 7.5 years and 8.8 ± 11.2 ng/ml, respectively. The overall cancer detection rate was 649/1043 (62.2%), with 521/1043 (50%) men harboring sPCa. Additional SB diagnosed sPCa in 98/1043 men (9.4%) and nsPCa in 71/1043 men (6.8%). Multivariate analysis showed that sPCa diagnosed by additional SB was significantly higher in patients with PI-RADS 2-4 lesions compared to PI-RADS 5 lesions (p < 0.01; OR 4.4 (95% CI 1.50 – 17.8)), and significantly lower in patients with transitional zone lesions compared to peripheral zone lesions (p=0.03; OR 0.47 (95% CI 0.24 – 0.91)) as well as in patients with smaller prostates (p=0.04; OR 0.99 (95% CI 0.98 – 0.99)). Multivariate analysis showed that nsPCa diagnosis solely with SB was significantly higher in men with larger prostates (p= <0.01; OR 1.02 (95% CI 1.01 – 1.02)) and significantly lower in patients with PI-RADS 4 lesions compared to PI-RADS 5 (p < 0.01; OR 0.04 (95% CI 0.01 – 0.38)). Omitting SB in men with PIRADS 5 lesions would have missed sPCa in 7 out of 246 men (2.8%). Lastly, no sPCa was missed when further restricting TB to patients with lesions localized in non-peripheral zones of the prostate.
Conclusions: An individualized biopsy strategy seems necessary to address the sPCa vs nsPCa trade-off. According to our data, patients harbouring a PI-RADS 5 lesion in a relatively small gland which is localized in the transitional zone could safely omit a SB.
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