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Objective: To evaluate the 4Kscore test's low risk cut-off of 7.5% as the indication to proceed with a prostate biopsy by combining data from 2 independent prospective multicentre trials in the United States which have validated the 4Kscore test as a continuous score to predict clinically significant prostate cancer.Materials and Methods: We analyzed the data from 2 prospective multicenter trials in the United states to determine the number of men who could safely avoid a prostate biopsy and the presence of clinically significant cancers detected, at a 4Kscore cut-off of 7.5%. We evaluated this in the entire cohort, and 3 subgroups of men aged 45-75 years with a total prostate specific antigen between 3.0 and 10.0 ng/mL, African American, and non-African American men.Results: The analysis included 1378 patients. The combination analysis at a 7.5% threshold to decide upon a prostate biopsy, was associated with a 32% biopsy reduction. A total of 21 men (4.8%) with a low risk 4Kscore had International society of Urological Pathology, prostate cancer Grade group (GG) 2 or 3 cancer, leading to a sensitivity of 94% for detecting GG ≥2 cancer, and a negative predictive value of 95%. There were no GG ≥4 cancers with a low risk 4Kscore. Analyses in various subgroups afforded similar results.Conclusion: A 4Kscore test cut-off of 7.5% allowed a significant biopsy reduction, while maintaining high sensitivity and NPV for detecting and ruling out aggressive prostate cancer. [ABSTRACT FROM AUTHOR]

Since the "prostate-specific antigen (PSA) era," we have seen an increase in unnecessary biopsies, which has ultimately lead to an overtreatment of low-risk cancers. Given the limitations of prostate-specific antigen and the invasive nature of prostate biopsy several serum and urinary biomarkers have been developed. In this paper, we provide a comprehensive review of the available biomarkers for the detection clinically significant prostate cancer namely PHI, 4Kscore, PCA3, MiPS, SelectMDx, ExosomeDX. Current literature suggests that these biomarkers can improve detection of clinically significant prostate cancer reducing overtreatment and making treatment strategies more cost-effective. Nevertheless, large prospective studies with head-to-head-comparisons of the available biomarkers are necessary to fully assess the potential of incorporating biomarkers in routine clinical practice. [ABSTRACT FROM AUTHOR]