MP02-01 CLINICAL UTILITY OF PHI (PROSTATE HEALTH INDEX) IN MEN WITH TPSA > 10 NG/ML. RESULTS FROM A MULTICENTRIC EUROPEAN STUDY

Abstract

You have accessJournal of UrologyProstate Cancer: Markers I1 Apr 2016MP02-01 CLINICAL UTILITY OF PHI (PROSTATE HEALTH INDEX) IN MEN WITH TPSA > 10 NG/ML. RESULTS FROM A MULTICENTRIC EUROPEAN STUDY Giovanni Lughezzani, Massimo Lazzeri, Rodolfo Hurle, NicolòMaria Buffi, Paolo Casale, Girolamo Fiorini, Roberto Peschechera, Luisa Pasini, Silvia Zandegiacomo, Vittorio Bini, Alessio Benetti, Alexander Haese, Joan Palou Redorta, Thomas McNicholas, Alexandre de la Taille, and Giorgio Guazzoni Giovanni LughezzaniGiovanni Lughezzani More articles by this author , Massimo LazzeriMassimo Lazzeri More articles by this author , Rodolfo HurleRodolfo Hurle More articles by this author , NicolòMaria BuffiNicolòMaria Buffi More articles by this author , Paolo CasalePaolo Casale More articles by this author , Girolamo FioriniGirolamo Fiorini More articles by this author , Roberto PeschecheraRoberto Peschechera More articles by this author , Luisa PasiniLuisa Pasini More articles by this author , Silvia ZandegiacomoSilvia Zandegiacomo More articles by this author , Vittorio BiniVittorio Bini More articles by this author , Alessio BenettiAlessio Benetti More articles by this author , Alexander HaeseAlexander Haese More articles by this author , Joan Palou RedortaJoan Palou Redorta More articles by this author , Thomas McNicholasThomas McNicholas More articles by this author , Alexandre de la TailleAlexandre de la Taille More articles by this author , and Giorgio GuazzoniGiorgio Guazzoni More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.1873AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The diagnostic accuracy of total PSA (tPSA) to determine the presence of prostate cancer (PCa) even in patients with high tPSA levels remains questionable. Evidences regarding the diagnostic accuracy of p2PSA and its derivatives (%p2PSA and Prostate Health Index - PHI) to predict the presence of PCa in individuals with high tPSA levels are lacking. We tested the hypothesis that these markers could assist clinicians in the biopsy decision path of patients with tPSA>10 ng/mL. METHODS The data analysis consisted of a nested case control study from the PRO-PSA Multicentric European Study (PROMEtheuS) project (detailed descriptions of study design, setting, ethics, centers and patients are available at http://www.controlled-trials.com/ISRCTN04707454). The study was designed to test the sensitivity, specificity, and accuracy of p2PSA and its derivatives, %p2PSA and the PHI in men with a tPSA > 10 ng/ml. in determining the presence of PCa at biopsy in comparison to tPSA, fPSA, and %fPSA. We calculated the number of prostate biopsies that could have been spared by using these markers to decide whether or not to perform a biopsy. A secondary end-point was to determine the relationship between the index tests (p2PSA, %p2PSA and PHI) and PCa characteristics. Multivariable logistic regression models were complemented by predictive accuracy analysis. RESULTS PCa was diagnosed in 136 out of 262 patients (51.9%). Specifically, 30 patients were diagnosed with a Gleason score (GS) 6 PCa (22.1%), while 66 (48.5%) and 40 (29.4%) were diagnosed with a GS 7 and 8-10 PCa, respectively (29.4%). Total PSA, p2PSA, %p2PSA and PHI values were significantly higher (p<0.005) and %fPSA values significantly lower (p<0.0001) in patients with PCa relative to those with a negative biopsy. In accuracy analyses, %p2PSA and PHI (AUCs: 0.80 and 0.81 respectively) were the most accurate predictors of PCa, and significantly outperformed tPSA (AUC: 0.61), fPSA (AUC: 0.54), %fPSA (AUC: 0.67) and p2PSA (AUC: 0.66) (all p≤0.001). In multivariable logistic regression models, both %p2PSA and PHI achieved the independent predictor status and significantly increased the accuracy of the base multivariable model by a 6.9% and 6.7% extent (p<0.05). The use %p2PSA and PHI in the biopsy decision path would decrease the number of unnecessary biopsies by a 48.4-50.0% extent, while missing only few cases with clinically significant PCa. Finally, Gleason score was significantly related to p2PSA, %p2PSA and PHI levels. CONCLUSIONS The results of our study support the diagnostic effectiveness of %p2PSA and PHI even in patients with a tPSA >10 ng/mL. Further validation studies with larger sample size are needed to corroborate our findings. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e9 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Giovanni Lughezzani More articles by this author Massimo Lazzeri More articles by this author Rodolfo Hurle More articles by this author NicolòMaria Buffi More articles by this author Paolo Casale More articles by this author Girolamo Fiorini More articles by this author Roberto Peschechera More articles by this author Luisa Pasini More articles by this author Silvia Zandegiacomo More articles by this author Vittorio Bini More articles by this author Alessio Benetti More articles by this author Alexander Haese More articles by this author Joan Palou Redorta More articles by this author Thomas McNicholas More articles by this author Alexandre de la Taille More articles by this author Giorgio Guazzoni More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...