High prostate cancer gene 3 ( PCA 3) scores are associated with elevated Prostate Imaging Reporting and Data System ( PI ‐ RADS ) grade and biopsy Gleason score, at magnetic resonance imaging/ultrasonography fusion software‐based targeted prostate biopsy after a previous negative standard biopsy

Objective To determine the association among prostate cancer gene 3 ( PCA 3) score, Prostate Imaging Reporting and Data System ( PI ‐ RADS ) grade and Gleason score, in a cohort of patients with elevated prostate‐specific antigen ( PSA ), undergoing magnetic resonance imaging/ultrasonography fusion software‐based targeted prostate biopsy ( TB x) after a previous negative randomised ‘standard’ biopsy ( SB x). Patients and Methods In all, 282 patients who underwent TB x after previous negative SB x and a PCA 3 urine assay, were enrolled. The associations between PCA 3 score/ PI ‐ RADS and PCA 3 score/Gleason score were investigated by K‐means clustering, a receiver operating characteristic analysis and binary logistic regression. Results The PCA 3 score difference for the negative vs positive TB x cohorts was highly statistically significant. A 1‐unit increase in the PCA 3 score was associated to a 2.4% increased risk of having a positive TB x result. A PCA 3 score of >80 and a PI ‐ RADS grade of ≥4 were independent predictors of a positive TB x. The association between the PCA 3 score and PI ‐ RADS grade was statistically significant (the median PCA 3 score for PI ‐ RADS grade groups 3, 4, and 5 was 58, 104, and 146, respectively; P = 0.006). A similar pattern was detected for the relationship between the PCA 3 score and Gleason score; an increasing PCA 3 score was associated with a worsening Gleason score (median PCA 3 score equal to 62, 105, 132, 153, 203, and 322 for Gleason Score 3+4, 4+3, 4+4, 4+5, 5+4, and 5+5, respectively; P < 0.001). Conclusion TB x improved PCA 3 score diagnostic and prognostic performance for prostate cancer. The PCA 3 score was directly associated both with biopsy Gleason score and PI ‐ RADS grade: notably, in the ‘indeterminate’ PI ‐ RADS grade 3 subgroup.