PI-06 LATE-BREAKING ABSTRACT: THE 4KSCORE ^TM TEST AS A PREDICTOR OF HIGH-GRADE PROSTATE CANCER ON BIOPSY

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You have accessJournal of UrologyPlenary Session I: Best Abstract and Late Breaking Abstracts1 Apr 2014PI-06 LATE-BREAKING ABSTRACT: THE 4KSCORETM TEST AS A PREDICTOR OF HIGH-GRADE PROSTATE CANCER ON BIOPSY Daniel Lin, Shawn McGee, Kimberly Rieger-Christ, Neal Shore, Christopher Pieczonka, James Cochran, Raoul Concepcion, Igor Dumbadze, Kenneth Deck, James Bailen, Ralph Jonathan Henderson, Paul Sieber, Timothy Dean Langford, Scott Asroff, and Todd Waldmann Daniel LinDaniel Lin More articles by this author , Shawn McGeeShawn McGee More articles by this author , Kimberly Rieger-ChristKimberly Rieger-Christ More articles by this author , Neal ShoreNeal Shore More articles by this author , Christopher PieczonkaChristopher Pieczonka More articles by this author , James CochranJames Cochran More articles by this author , Raoul ConcepcionRaoul Concepcion More articles by this author , Igor DumbadzeIgor Dumbadze More articles by this author , Kenneth DeckKenneth Deck More articles by this author , James BailenJames Bailen More articles by this author , Ralph Jonathan HendersonRalph Jonathan Henderson More articles by this author , Paul SieberPaul Sieber More articles by this author , Timothy Dean LangfordTimothy Dean Langford More articles by this author , Scott AsroffScott Asroff More articles by this author , and Todd WaldmannTodd Waldmann More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.2578AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Prostate Specific Antigen (PSA) has modest specificity and most men with elevated PSA do not have prostate cancer (PCa). Hundreds of thousands of negative prostate biopsy (Bx) procedures are conducted each year in the United States (US), and about half of the ∼250,000 positive Bx are Gleason Score (GS) = 6. A four kallikrein assay panel of total, free and intact PSA, and human Kallikrein 2 (hK2) combined in an algorithm with age, digital rectal exam (DRE) and prior biopsy status (4Kscore™ test) has been adapted from previous European studies, where the test was found to be an accurate predictor of the result of Bx, and in particular, high-grade disease of GS ≥7. The goal is to replicate the European performance in an independent, prospective, blinded study in the US. METHODS The first 300 patients enrolled from Oct. 2013 to Jan. 2014 form this prespecified interim analysis. Enrollment was open to all men scheduled for Bx at 26 US Urology centers. After phlebotomy, a transrectal ultrasound Bx (≥ 10 cores) was performed. The four assays were performed at OPKO Lab, Nashville, TN, a CLIA-certified laboratory. Histopathology was conducted by the established practice at each site. Independent biostatisticians evaluated the laboratory and Bx data. RESULTS The 4Kscore test provided a very high degree of discrimination compared to a clinical algorithm built on PSA and clinical data (Table). Calibration of the 4Kscore algorithm was near perfect compared to its European version. For one illustrative cut point, the 4Kscore test would have reduced the number of Bx’s by 41%, with a Negative Predictive Value (NPV) of 97%. Decision analysis demonstrated that clinical decision-making would be improved by the use of the 4Kscore test. CONCLUSIONS The 4Kscore test, using fresh samples evaluated in a commercial laboratory, yields superior performance compared with a clinical model. The 4Kscore test reports a probability of finding high-grade cancer that can inform clinically relevant, shared decision-making between urologist and patient. The prospective study is completing its validation phase with an additional 900 patients in the cohort. Algorithm Outcome Area Under the Curve (95% confidence interval) 4Kscore PCa (GS ≥ 7) 0.855 (0.80, 0.90) Clinical (PSA, Age, DRE, Prior Bx) PCa (GS ≥ 7) 0.690 (0.63, 0.75) 4Kscore Any PCa 0.752 (0.70, 0.81) Clinical (PSA, Age, DRE, Prior Bx)