Prostate cancer antigen 3 (PCA3) scoring, based on urinary PCA3:PSA mRNA ratios, might improve estimation of prostate cancer risk, thereby reducing the need for prostate biopsies. In a validation trial, a PCA3 score >60 had a positive predictive value of 80% and a PCA3 score <20 had a negative predictive value of 88% in men undergoing initial and repeat biopsies, respectively; addition of PCA3 score to the PCPT risk calculator significantly improved the classification of any prostate cancer (P <0.001 in both groups), as well as high-grade cancers in men undergoing repeat biopsy (P ≤0.003).