Purpose We hypothesized that systematic biopsies (SBx) value for clinically significant PCa (csPCa) detection, in addition to mpMRI targeted biopsies (TBx), may vary significantly according to mpMRI index lesion (IL) characteristics. Methods We identified 1350 men with an mpMRI suspicious lesion (PI-RADS >= 3), defined as IL, who underwent TBx and SBx at three referral centres. The outcome was SBx added value in csPCa (grade group >= 2 PCa detected at SBx and missed by TBx) detection. To this aim, we performed multivariable logistic regression analyses (MVA). Furthermore, we explored the interaction between IL volume and SBx csPCa added value, across different PI-RADS categories, using lowess function. Results Overall, 569 (42%) men had csPCa at TBx and 78 (6%) csPCa were identified at SBx only. At MVA PSA (OR 0.90; p < 0.05) and IL volume (OR 0.58; p < 0.05) were associated with SBx csPCa added value. At interaction analyses, a nonlinear correlation between PI-RADS and SBx csPCa added value was identified with a decrease from roughly 10 to 4% followed by a substantial plateau at 1.2 ml and 0.6 ml for PI-RADS 3 and 4, respectively. For PI-RADS 5 lesions SBx csPCa added was constantly lower than 4%. Conclusions Increasing IL volume in PI-RADS 3 and 4 lesions is associated with reduction in SBx csPCa added value. For diagnostic purposes, SBx could be omitted in men with IL larger than 1.2 ml and 0.6 ml for PI-RADS 3 and 4, respectively. Conversely, for PI-RADS 5, SBx csPCa added value was minimal regardless of IL volume.
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