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Medical AI Inquiry: You was designed to assist in medical decision-making based on the provided user questions. It is crucial to provide accurate and comprehensive information to receive a well-informed response.  Labels: BACKGROUND, OBJECTIVE, METHODS, METHODS, METHODS. Meshes: Aged, Area Under Curve, Biopsy, Large-Core Needle, Cohort Studies, Humans, Kallikreins, Male, Middle Aged, Neoplasm Grading, Prospective Studies, Prostate-Specific Antigen, Prostatic Neoplasms, ROC Curve, Sensitivity and Specificity, Tissue Kallikreins, United States.
user
Does a multi-institutional prospective trial in the USA confirm that the 4Kscore accurately identifies men with high-grade prostate cancer? Context: The 4Kscore combines measurement of four kallikreins in blood with clinical information as a measure of the probability of significant (Gleason ≥7) prostate cancer (PCa) before prostate biopsy. To perform the first prospective evaluation of the 4Kscore in predicting Gleason ≥7 PCa in the USA. Prospective enrollment of 1012 men scheduled for prostate biopsy, regardless of prostate-specific antigen level or clinical findings, was conducted at 26 US urology centers between October 2013 and April 2014. The 4Kscore. The primary outcome was Gleason ≥7 PCa on prostate biopsy. The area under the receiver operating characteristic curve, risk calibration, and decision curve analysis (DCA) were determined, along with comparisons of probability cutoffs for reducing the number of biopsies and their impact on delaying diagnosis.
assistant
Gleason ≥7 PCa was found in 231 (23%) of the 1012 patients. The 4Kscore showed excellent calibration and demonstrated higher discrimination (AUC 0.82) and net benefit compared to a modified Prostate Cancer Prevention Trial Risk Calculator 2.0 model and standard of care (biopsy for all men) according to DCA. A possible reduction of 30-58% in the number biopsies was identified with delayed diagnosis in only 1.3-4.7% of Gleason ≥7 PCa cases, depending on the threshold used for biopsy. Pathological assessment was performed according to the standard of care at each site without centralized review. Final Decision: yes