Volume 11, Number 3Review ArticlesPredictive Models for Newly Diagnosed Prostate Cancer PatientsManagement UpdatePeter T ScardinoWilliam T Lowrance[Rev Urol.2009;11(3):117-126 doi: 10.3909/riu0456]2009 MedReviews®, LLC©Accurate risk assessment is of paramount importance to newly diagnosedprostate cancer patients and their physicians. Risk prediction models helpidentify those at high (or low) risk of disease progression and guide discussionsabout prognosis and treatment. Widely used, well-validated predictiontools are based on standard, readily available clinical and pathologic parameters,but do not include biomarkers, some of which may have an importantrole in predicting prognosis or determining therapeutic options. A newapproach, known as systems pathology, may improve the accuracy of traditionalprediction methods and provide patients with a more personalized riskassessment of clinically relevant outcomes. The ultimate goal of predictionmodels is to improve medical decision making.Prostate cancerPrognosisStatistical modelNomogram
Volume 19, Number 3Review ArticlesClinical Performance of the 4Kscore Test to Predict High-grade Prostate Cancer at Biopsy: A Meta-analysis of US and European Clinical Validation Study ResultsPredictive Performance EvaluationStephen M ZappalaPeter T ScardinoYan DongVincent LinderDavid OkronglyThe 4Kscore® Test (OPKO Diagnostics, Woburn, MA) is a blood test utilized prior to a prostate biopsy to determine a patient’s risk of high-grade prostate cancer (PCa) should the biopsy be performed, thus providing critical information in the clinical management of men with a suspicious prostate-specific antigen value or digital rectal examination result. Multiple US and European clinical studies confirmed that a prebiopsy 4Kscore Test has a high degree of discrimination for a subsequent discovery of high-grade (Gleason score ≥7) PCa. The aim of this study was to evaluate the predictive accuracy of the 4Kscore Test to discriminate between patients with and without high-grade PCa based on published clinical validation studies. A systematic review and meta-analysis of the eligible 4Kscore Test clinical validation studies was conducted. The pooled area under the curve (AUC) of the 4Kscore Test as reported from all the studies, and the heterogeneity among these studies were analyzed and repeated for subgroups of the studies. Twelve clinical validation studies were included in the meta-analysis, comprising a total of 11,134 patients. The pooled AUC to discriminate for high-grade PCa for all 12 studies was 0.81 (fixed effects 95% CI, 0.80-0.83). Restricting the analysis to the six publications that used the contemporary 4Kscore Test algorithm led to very similar results (AUC 0.81; 95% CI, 0.79-0.83). Heterogeneity was high among all of the 12 studies, as well as among the six publications that used the contemporary 4Kscore Test (Cochrane’s Q test, p = 0.001 for both); however, in both cases, after exclusion of a single outlying study with a much lower AUC, heterogeneity was no longer significant (p = 0.08 and p = 0.21). The pooled estimate of 4Kscore Test discrimination (AUC) for high-grade PCa is .0.80, and is consistent across multiple US and European clinical validation studies. [Rev Urol. 2017;19(3):149–155 doi: 10.3909/riu0776] © 2017 MedReviews®, LLCBiopsyBiomarkers4KscoreHigh-grade prostate cancerEarly detection