PD46-02 MULTICENTER EVALUATION OF THE PROSTATE HEALTH INDEX (PHI) FOR DETECTION OF AGGRESSIVE PROSTATE CANCER IN BIOPSY-NAÏVE MEN

Abstract

You have accessJournal of UrologyProstate Cancer: Detection and Screening V1 Apr 2015PD46-02 MULTICENTER EVALUATION OF THE PROSTATE HEALTH INDEX (PHI) FOR DETECTION OF AGGRESSIVE PROSTATE CANCER IN BIOPSY-NAÏVE MEN Claire de la Calle, Dattatraya Patil, John Wei, Douglas Scherr, Lori Sokoll, Daniel Chan, Javed Siddiqui, Juan Miguel Mosquera, Mark Rubin, and Martin Sanda Claire de la CalleClaire de la Calle More articles by this author , Dattatraya PatilDattatraya Patil More articles by this author , John WeiJohn Wei More articles by this author , Douglas ScherrDouglas Scherr More articles by this author , Lori SokollLori Sokoll More articles by this author , Daniel ChanDaniel Chan More articles by this author , Javed SiddiquiJaved Siddiqui More articles by this author , Juan Miguel MosqueraJuan Miguel Mosquera More articles by this author , Mark RubinMark Rubin More articles by this author , and Martin SandaMartin Sanda More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2733AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The Prostate Health Index (PHI) is a new formula that combines three well-known biomarkers: total PSA, free PSA and [-2]proPSA (p2PSA). PHI has been shown to increase specificity of the individual biomarkers in cohorts comprised of subjects with previous prostate biopsies as well as subjects with no history of biopsy. Here we tested PHI's ability to discern aggressive prostate cancer from indolent or no cancer on a biopsy-naïve population. METHODS Two independent prospective cohorts of 561 and 395 subjects were used for validation of the results. Each cohort recruited patients at different institutions. Criteria of inclusion were no history of prostate cancer or of prostate biopsy. Each subject had serum collected for total pre-biopsy PSA, %free PSA and p2PSA testing on the Beckman Coulter Access 2 prior to biopsy. PHI was calculated as (p2PSA/freePSA)∗sqrt (PSA). Bootstrap sampling provided the estimates for the performance measures including sensitivity and specificity. PHI cut point and corresponding specificities were calculated at fixed sensitivities of 95%, 90%, and 80%. Improvement in specificity was determined by bootstrap estimated standard error. RESULTS In the primary cohort, 20.3% of patients were found to have aggressive prostate cancer (Gleason score > 7). Higher PHI values were significantly associated with Gleason 7 score or higher. Mean PHI was 74.6 (SD ± 68.2) in the Gleason 7 score or higher group versus 32.2 (SD ± 18.9) in the less than Gleason 7 group (p<0.001). PHI's ability to detect aggressive prostate cancer yielded an AUC of 0.815 and its specificity was significantly higher than total pre-biopsy PSA and % free PSA specificities. At 95% sensitivity PHI specificity was 36.0% versus 17.2% and 19.4% for total pre-biopsy PSA and % free PSA respectively. At 95% sensitivity in detecting aggressive prostate cancer, the optimal PHI cut point was 24, which would help avoid 41% of unnecessary biopsies. Validation cohort analysis confirmed the improvement of specificity with PHI overall. The pre-determined PHI cutoff of 24 led to 36% biopsies avoided and very few aggressive cancers missed. CONCLUSIONS These results demonstrate that the prostate health index detects aggressive prostate cancer with a better specificity than total PSA and percent free PSA in a biopsy-naïve population, and could be a useful tool to decrease unnecessary prostate biopsies. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e956-e957 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Claire de la Calle More articles by this author Dattatraya Patil More articles by this author John Wei More articles by this author Douglas Scherr More articles by this author Lori Sokoll More articles by this author Daniel Chan More articles by this author Javed Siddiqui More articles by this author Juan Miguel Mosquera More articles by this author Mark Rubin More articles by this author Martin Sanda More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...