You have accessJournal of UrologyProstate Cancer: Detection and Screening V1 Apr 20122206 THE NCI EARLY DETECTION RESEARCH NETWORK (EDRN) URINARY PCA3 VALIDATION TRIAL John Wei, Martin Sanda, Ian Thompson, Alan Partin, Zideng Feng, Lori Sokoll, Jack Groskopf, Elissa Brown, Yair Lotan, Adam Kibel, Erik Busby, Mohamed Bidair, Dan Lin, Samir Taneja, and Rosalia Viterbo John WeiJohn Wei Ann Arbor, MI More articles by this author , Martin SandaMartin Sanda Boston, MA More articles by this author , Ian ThompsonIan Thompson San Antonio, TX More articles by this author , Alan PartinAlan Partin Baltimore, MD More articles by this author , Zideng FengZideng Feng Seattle, WA More articles by this author , Lori SokollLori Sokoll Baltimore, MD More articles by this author , Jack GroskopfJack Groskopf San Diego, CA More articles by this author , Elissa BrownElissa Brown Seattle, WA More articles by this author , Yair LotanYair Lotan Dallas, TX More articles by this author , Adam KibelAdam Kibel St. Louis, WA More articles by this author , Erik BusbyErik Busby Birmingham, AL More articles by this author , Mohamed BidairMohamed Bidair San Diego, CA More articles by this author , Dan LinDan Lin Seattle, WA More articles by this author , Samir TanejaSamir Taneja New York City, NY More articles by this author , and Rosalia ViterboRosalia Viterbo Philadelphia, PA More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.2381AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Widespread use of PSA screening has raised concerns of overdiagnosis of low risk and underdiagnosis of high grade cancer. This is primarily due to the low sensitivity and specificity of PSA. PCA3,a non-coding large chain ribonucleic acid, is significantly over-expressed in cancer tissue and quantitatively measured by a novel urinary assay. The objective of this NCI EDRN trial was to conduct a comprehensive, independent validation of the PROGENSA PCA3 Assay for the detection of prostate cancer. METHODS A prospective, PROBE-compliant NCI validation trial was undertaken at 11 clinical sites to evaluate PCA3's positive predictive value (PPV, PCA3 score >60) in the initial biopsy setting and negative predictive value (NPV, PCA3 score <20) in the repeat biopsy setting. PCA3 was obtained prior to biopsy but following an attentive DRE. We hypothesized that PPV for an initial prostate biopsy to be at least 55% and that NPV for a repeat biopsy to be at least 75%.The accuracy of PCA3 in detecting any prostate cancer and secondarily, high grade cancer (Gleason > 7),was compared to PCPT risk calculator through ROC curve analysis. RESULTS 880 eligible men (mean age 62 years) were enrolled; 305 had a prior negative prostate biopsy. 99% had an informative PCA3 test. For the detection of any cancer, PPV was 80% (95% CI: 0.72–0.86) in the initial biopsy group while NPV was 88%(95% CI: 0.81–0.93) in the repeat biopsy group. PCA3 performance was superior to PCPT risk estimation (see Figures) and improved upon the detection of any cancer (p<0.006) and high grade cancer (p<0.02) when combined with the PCPT risk model. CONCLUSIONS Independent validation of PCA3 demonstrated a high PPV in the initial biopsy setting and a high NPV in the repeat biopsy setting. Given the significant improvements in risk estimation over PCPT, PCA3 is expected to greatly enhance clinical decision making. Figure: PCA3 ability to detect prostate cancer was superior to PCPT risk calculator in both the initial (Figure 1, p < 0.0001) and repeat biopsy setting (Figure 2, p=0.001) © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e889-e890 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information John Wei Ann Arbor, MI More articles by this author Martin Sanda Boston, MA More articles by this author Ian Thompson San Antonio, TX More articles by this author Alan Partin Baltimore, MD More articles by this author Zideng Feng Seattle, WA More articles by this author Lori Sokoll Baltimore, MD More articles by this author Jack Groskopf San Diego, CA More articles by this author Elissa Brown Seattle, WA More articles by this author Yair Lotan Dallas, TX More articles by this author Adam Kibel St. Louis, WA More articles by this author Erik Busby Birmingham, AL More articles by this author Mohamed Bidair San Diego, CA More articles by this author Dan Lin Seattle, WA More articles by this author Samir Taneja New York City, NY More articles by this author Rosalia Viterbo Philadelphia, PA More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...
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