A multi-institutional prospective trial in the USA confirms that the 4Kscore accurately identifies men with high-grade prostate cancer
| Autor: | Igor Dumbadze, Kimberley Rieger-Christ, Todd M. Waldmann, John W. Scott, Kenneth B. Deck, Neal D. Shore, John J. Munoz, Richard D. David, James S. Cochran, Evan B. Krisch, James Bailen, Christopher Michael Pieczonka, Raoul S. Concepcion, Timothy Dean Langford, Scott Asroff, Dipen J. Parekh, Fredrick N. Wolk, Daniel Sjöberg, Michael S. Grable, Ralph Jonathan Henderson, Michael Gambla, Shawn M. McGee, Daniel Saltzstein, Lawrence Karsh, Sanoj Punnen, Daniel W. Lin, Stephen M. Zappala, Paul Sieber |
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| Rok vydání: | 2014 |
| Předmět: |
Oncology
Male medicine.medical_specialty Prostate biopsy Urology Disease urologic and male genital diseases Sensitivity and Specificity Cohort Studies Prostate cancer Internal medicine Biopsy medicine Humans Prostate Cancer Prevention Trial Prospective Studies Pathological Aged Receiver operating characteristic medicine.diagnostic_test business.industry Cancer Prostatic Neoplasms Middle Aged Prostate-Specific Antigen medicine.disease United States Surgery ROC Curve Area Under Curve Kallikreins Biopsy Large-Core Needle Neoplasm Grading business Tissue Kallikreins |
| Zdroj: | European urology. 68(3) |
| ISSN: | 1873-7560 |
| Popis: | Background 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. Objective To perform the first prospective evaluation of the 4Kscore in predicting Gleason ≥7 PCa in the USA. Design, setting, and participants 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. Intervention The 4Kscore. Outcome measurements and statistical analysis 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. Results and limitations 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. Conclusion The 4Kscore showed excellent diagnostic performance in detecting significant PCa. It is a useful tool in selecting men who have significant disease and are most likely to benefit from a prostate biopsy from men with no cancer or indolent cancer. Patient summary The 4Kscore provides each patient with an accurate and personalized measure of the risk of Gleason ≥7 cancer to aid in decision-making regarding the need for prostate biopsy. |
| Databáze: | OpenAIRE |
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