Mp41-02 Combining Serum Prostate Health Index With Urinary Pca3 and Tmprss2:erg Rna Testing Improves Detection of Clinically-Significant Prostate Cancer

You have accessJournal of UrologyProstate Cancer: Markers I (MP41)1 May 2024MP41-02 COMBINING SERUM PROSTATE HEALTH INDEX WITH URINARY PCA3 AND TMPRSS2:ERG RNA TESTING IMPROVES DETECTION OF CLINICALLY-SIGNIFICANT PROSTATE CANCER Vikram M. Narayan, Nicholas Eyrich, Eugene Huang, Yingye Zheng, John Wei, Lori Sokoll, Daniel Chan, Dattatraya Patil, Arul Chinnaiyan, Scott A. Tomlins, Yair Lotan, Daniel Lin, Douglas Scherr, Adam Kibel, Samir S. Taneja, Mohamed Bidair, Ian M. Thompson, and Martin G. Sanda Vikram M. NarayanVikram M. Narayan , Nicholas EyrichNicholas Eyrich , Eugene HuangEugene Huang , Yingye ZhengYingye Zheng , John WeiJohn Wei , Lori SokollLori Sokoll , Daniel ChanDaniel Chan , Dattatraya PatilDattatraya Patil , Arul ChinnaiyanArul Chinnaiyan , Scott A. TomlinsScott A. Tomlins , Yair LotanYair Lotan , Daniel LinDaniel Lin , Douglas ScherrDouglas Scherr , Adam KibelAdam Kibel , Samir S. TanejaSamir S. Taneja , Mohamed BidairMohamed Bidair , Ian M. ThompsonIan M. Thompson , and Martin G. SandaMartin G. Sanda View All Author Informationhttps://doi.org/10.1097/01.JU.0001008896.93851.5b.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To determine whether combining prostate health index (phi) with urinary PCA3 and TMPRSS2:Erg (PCA3-T2Erg) RNA testing could improve selection for prostate biopsy. These biomarkers have been validated in Prostate Cancer (PCa) detection separately, but their combination to improve PCa detection has not previously been developed. METHODS: Prebiopsy blood and post-DRE urine specimens were assayed to predict biopsy outcomes from a training cohort and a validation cohort (1073 total patients across 11 academic centers). Clinical algorithms for combining serum phi and urinary PCA3-T2Erg to predict Grade Group ≥2 (GG2+) PCa were formulated using the training cohort (N=512), for optimal specificity at 95% sensitivity. Prediction rules and hypotheses were locked prior to validation using biopsy-naïve men from the NCI Detection Research Network (NCI-EDRN) urinary PCA3 trial (N=561). Rules were compared in weighted sum of specificity and sensitivity with weights specified a priori and p values were obtained via bootstrap in the validation study. RESULTS: In training and validation cohorts, respectively, median (and range) PSA=4.8ng/ml (0.3-460) and 5.0ng/ml (0.3-309); phi=35 (5-3767) and 41(10-545); PCA3 score=25 (0.7-313) and 26 (0.9-555); T2Erg score=6.3 (0-6031) and 5.1 (0-6991). Biopsy diagnosis in the development and validation cohorts, respectively, was benign in 49% and 53%; GG1 in 21% and 21%; GG≥2 in 30% and 26%. Performance of algorithms combining phi and PCA3-T2Erg to predict GG2+PCa in the training cohort are tabulated. Validation analysis showed that phi combined with urinary PCA3 outperformed phi alone (primary analysis p=0.002); and combining serum phi with urinary PCA3-T2Erg RNA testing outperformed urinary RNA testing alone in each of three algorithms reflecting different potential clinical workflows: 1) serum phi and urine PCA3/T2Erg tested simultaneously, any one of them exceeding its own threshold (p=0.04); 2) urine PCA3-T2Erg tested first and those in the grey zone resolved by subsequent phi test (p=0.03); and 3) phi tested first and those in the grey zone resolved by subsequent urine PCA3-T2Erg testing (p=0.002). CONCLUSIONS: Sequential combination of serum phi testing and urinary PCA3-T2Erg RNA assay improves selection of men for initial prostate biopsy. Source of Funding: NIH U01 CA113913 (MGS PI); NIH U24 CA115102 (DWC PI); National Cancer Institute (NCI) Early Detection Research Network. phi reagents provided by Beckman Coulter, Inc © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e673 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Vikram M. Narayan More articles by this author Nicholas Eyrich More articles by this author Eugene Huang More articles by this author Yingye Zheng More articles by this author John Wei More articles by this author Lori Sokoll More articles by this author Daniel Chan More articles by this author Dattatraya Patil More articles by this author Arul Chinnaiyan More articles by this author Scott A. Tomlins More articles by this author Yair Lotan More articles by this author Daniel Lin More articles by this author Douglas Scherr More articles by this author Adam Kibel More articles by this author Samir S. Taneja More articles by this author Mohamed Bidair More articles by this author Ian M. Thompson More articles by this author Martin G. Sanda More articles by this author Expand All Advertisement PDF downloadLoading ...