Head-to-Head Comparison of Prostate Health Index and Urinary PCA3 for Predicting Cancer at Initial or Repeat Biopsy
2013; Lippincott Williams & Wilkins; Volume: 190; Issue: 2 Linguagem: Inglês
10.1016/j.juro.2013.02.3184
ISSN1527-3792
AutoresVincenzo Scattoni, Massimo Lazzeri, Giovanni Lughezzani, Stefano De Luca, Roberto Passera, Enrico Bollito, Donato Randone, Firas Abdollah, Umberto Capitanio, Alessandro Larcher, Giuliana Lista, Giulio Maria Gadda, Vittorio Bini, Francesco Montorsi, Giorgio Guazzoni,
Tópico(s)Statistical Methods in Clinical Trials
ResumoNo AccessJournal of UrologyAdult Urology1 Aug 2013Head-to-Head Comparison of Prostate Health Index and Urinary PCA3 for Predicting Cancer at Initial or Repeat Biopsy Vincenzo Scattoni, Massimo Lazzeri, Giovanni Lughezzani, Stefano De Luca, Roberto Passera, Enrico Bollito, Donato Randone, Firas Abdollah, Umberto Capitanio, Alessandro Larcher, Giuliana Lista, Giulio Maria Gadda, Vittorio Bini, Francesco Montorsi, and Giorgio Guazzoni Vincenzo ScattoniVincenzo Scattoni Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy , Massimo LazzeriMassimo Lazzeri Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy , Giovanni LughezzaniGiovanni Lughezzani Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy , Stefano De LucaStefano De Luca Department of Urology, Ospedale Gradenigo, Torino, Italy , Roberto PasseraRoberto Passera Department of Urology, Ospedale Gradenigo, Torino, Italy , Enrico BollitoEnrico Bollito Department of Urology, Ospedale Gradenigo, Torino, Italy , Donato RandoneDonato Randone Department of Urology, Ospedale Gradenigo, Torino, Italy , Firas AbdollahFiras Abdollah Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy , Umberto CapitanioUmberto Capitanio Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy , Alessandro LarcherAlessandro Larcher Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy , Giuliana ListaGiuliana Lista Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy , Giulio Maria GaddaGiulio Maria Gadda Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy , Vittorio BiniVittorio Bini Department of Internal Medicine, University of Perugia, Perugia, Italy , Francesco MontorsiFrancesco Montorsi Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy , and Giorgio GuazzoniGiorgio Guazzoni Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.3184AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We performed a head-to-head comparison of the PHI (Prostate Health Index) and PCA3. Materials and Methods: We evaluated PHI and PCA3 performance in 211 patients undergoing initial (116) or repeat (95) prostate biopsy. Multivariable logistic regression analysis was done using the AUC to test the accuracy of PHI and PCA3 for predicting prostate cancer in the overall population and in each setting. Decision curve analysis was used to compare the clinical benefit of different models. Results: Overall, the AUC of the PHI (0.70) was significantly higher than the AUC of PCA3 (0.59), total prostate specific antigen (0.56) and free-to-total prostate specific antigen (0.60) (p = 0.043, 0.002 and 0.037, respectively). PHI was more accurate than PCA3 for predicting prostate cancer in the initial setting (AUC 0.69 vs 0.57) and in the repeat setting (AUC 0.72 vs 0.63), although no statistically significant difference was observed. Including PCA3 in the base multivariable model (prostate specific antigen plus free-to-total prostate specific antigen plus prostate volume) did not increase predictive accuracy in either setting (AUC 0.79 vs 0.80 and 0.75 vs 0.76, respectively). Conversely, including PHI in the base multivariable model improved predictive accuracy by 5% (AUC 0.79 to 0.84) and 6% (AUC 0.75 to 0.81) in the initial and repeat prostate biopsy settings, respectively. On decision curve analysis the highest net benefit was observed when PHI was added to the base multivariable model. Conclusions: PHI and PCA3 provide a significant increase in sensitivity and specificity compared to all other examined markers and they may help guide biopsy decisions. PCA3 does not increase the accuracy of predicting prostate cancer when PHI is assessed. References 1 : EAU guidelines on prostate cancer. Part 1: screening, diagnosis, and treatment of clinically localised disease. Eur Urol2011; 59: 61. Google Scholar 2 : The 2010 NCCN clinical practice guidelines in oncology on prostate cancer. J Natl Compr Canc Netw2010; 8: 145. Google Scholar 3 : Pelvic plexus block is more effective than periprostatic nerve block for pain control during office transrectal ultrasound guided prostate biopsy: a single center, prospective, randomized, double arm study. J Urol2012; 188: 417. Link, Google Scholar 4 : Mortality at 120 days after prostatic biopsy: a population-based study of 22,175 men. Int J Cancer2008; 123: 647. Google Scholar 5 : Preventing pain during office biopsy of the prostate: a single center, prospective, double-blind, 3-arm, parallel group, randomized clinical trial. Cancer2007; 110: 1708. Google Scholar 6 : Infectious complications and hospital admissions after prostate biopsy in a European randomized trial. Eur Urol2012; 61: 1110. Google Scholar 7 : Is repeat prostate biopsy associated with a greater risk of hospitalization?: Data from SEER-Medicare. J Urol2013; 189: 867. Link, Google Scholar 8 Hori S, Blanchet JS and McLoughlin J: From prostate-specific antigen (PSA) to precursor PSA (proPSA) isoforms: a review of the emerging role of proPSAs in the detection and management of early prostate cancer. BJU Int, Epub ahead of print July 3, 2012. Google Scholar 9 : ProPSA and diagnostic biopsy tissue DNA content combination improves accuracy to predict need for prostate cancer treatment among men enrolled in an active surveillance program. Urology2011; 77. 763 e1. Google Scholar 10 : A [−2]proPSA-based artificial neural network significantly improves differentiation between prostate cancer and benign prostatic diseases. Prostate2009; 69: 198. Google Scholar 11 : A multicenter study of [−2]pro-prostate specific antigen combined with prostate specific antigen and free prostate specific antigen for prostate cancer detection in the 2.0 to 10.0 ng/ml prostate specific antigen range. J Urol2011; 185: 1650. Link, Google Scholar 12 : Predicting prostate biopsy outcome: prostate health index (phi) and prostate cancer antigen 3 (PCA3) are useful biomarkers. Clin Chim Acta2012; 413: 1274. Google Scholar 13 : Comparative assessment of urinary prostate cancer antigen 3 and TMPRSS2:ERG gene fusion with the serum [−2]proprostate-specific antigen-based prostate health index for detection of prostate cancer. Clin Chem2013; 59: 280. Google Scholar 14 : Pre-analytical in-vitro stability of [−2]proPSA in blood and serum. Clin Biochem2011; 43: 926. Google Scholar 15 : The optimal rebiopsy prostatic scheme depends on patient clinical characteristics: results of a recursive partitioning analysis based on a 24-core systematic scheme. Eur Urol2011; 60: 834. Google Scholar 16 : The 2005 International Society of Urological Pathology (ISUP) Consensus Conference on Gleason Grading of Prostatic Carcinoma. Am J Surg Pathol2005; 29: 1228. Google Scholar 17 : Decision curve analysis: a novel method for evaluating prediction models. Med Decis Making2006; 26: 565. Google Scholar 18 : Prostate cancer gene 3 (PCA3): development and internal validation of a novel biopsy nomogram. Eur Urol2009; 56: 659. Google Scholar 19 : Diagnostic performance of PCA3 to detect prostate cancer in men with increased prostate specific antigen: a prospective study of 1,962 cases. J Urol2012; 188: 1726. Link, Google Scholar 20 : Use of [−2]proPSA and phi index for early detection of prostate cancer: a prospective of 452 patients. Prog Urol2012; 22: 279. Google Scholar 21 : Serum index test %[−2]proPSA and Prostate Health Index are more accurate than prostate specific antigen and %fPSA in predicting a positive repeat prostate biopsy. J Urol2012; 188: 1137. Link, Google Scholar 22 : Prostate-specific antigen (PSA) isoform p2PSA significantly improves the prediction of prostate cancer at initial extended prostate biopsies in patients with total PSA between 2.0 and 10 ng/ml: results of a prospective study in a clinical setting. Eur Urol2011; 60: 214. Google Scholar 23 Ramos CG, Valdevenito R, Vergara I et al: PCA3 sensitivity and specificity for prostate cancer detection in patients with abnormal PSA and/or suspicious digital rectal examination. First Latin American experience. Urol Oncol, Epub ahead of print June 9, 2012. Google Scholar 24 : Contemporary role of prostate cancer antigen 3 in the management of prostate cancer. Eur Urol2011; 60: 1045. Google Scholar 25 : Clinical utility of the PCA3 urine assay in European men scheduled for repeat biopsy. Eur Urol2008; 54: 1081. Google Scholar 26 Leyten GH, Hessels D, Jannink SA et al: Prospective multicentre evaluation of PCA3 and TMPRSS2-ERG gene fusions as diagnostic and prognostic urinary biomarkers for prostate cancer. Eur Urol, Epub ahead of print November 15, 2012. Google Scholar 27 : Preoperative prostate-specific antigen isoform p2PSA and its derivatives, %p2PSA and prostate health index, predict pathologic outcomes in patients undergoing radical prostatectomy for prostate cancer. Eur Urol2012; 61: 455. Google Scholar 28 : Prostate health index (phi) and prostate cancer antigen 3 (PCA3) significantly improve diagnostic accuracy in patients undergoing prostate biopsy. Prostate2013; 73: 227. Google Scholar 29 : Initial prostate biopsy: development and internal validation of a biopsy-specific nomogram based on the prostate cancer antigen 3 assay. Eur Urol2013; 63: 201. Google Scholar 30 : Clinical evaluation of the PCA3 assay in guiding initial biopsy decisions. J Urol2011; 185: 2119. Link, Google Scholar © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byTaneja S (2015) Re: Can Urinary PCA3 Supplement PSA in the Early Detection of Prostate Cancer?Journal of Urology, VOL. 194, NO. 1, (115-115), Online publication date: 1-Jul-2015.Fossati N, Lazzeri M and Larcher A (2015) Re: Editorial Comment on Clinical Performance of Serum Isoform -2proPSA (p2PSA) and its Derivatives, Namely %p2PSA and PHI (Prostate Health Index) in Men Younger than 60 Years of Age: Results from a Multicentric European StudyJournal of Urology, VOL. 194, NO. 1, (265-266), Online publication date: 1-Jul-2015.Taneja S (2014) Re: Clinical Performance of Serum Isoform -2proPSA (p2PSA) and its Derivatives, Namely %p2PSA and PHI (Prostate Health Index) in Men Younger than 60 Years of Age: Results from a Multicentric European StudyJournal of Urology, VOL. 192, NO. 2, (421-421), Online publication date: 1-Aug-2014.Porpiglia F, Russo F, Manfredi M, Mele F, Fiori C, Bollito E, Papotti M, Molineris I, Passera R and Regge D (2014) The Roles of Multiparametric Magnetic Resonance Imaging, PCA3 and Prostate Health Index—Which is the Best Predictor of Prostate Cancer after a Negative Biopsy?Journal of Urology, VOL. 192, NO. 1, (60-66), Online publication date: 1-Jul-2014. Volume 190Issue 2August 2013Page: 496-501Supplementary Materials Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.Keywordsprostate-specific antigenprostatic neoplasmsprostate cancer antigen 3, humanbiopsyprostateAcknowledgmentsBeckman Coulter, Italy provided Access Hybritech p2PSA reagents and the Access 2 Immunoassay system.MetricsAuthor Information Vincenzo Scattoni Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy More articles by this author Massimo Lazzeri Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy Financial interest and/or other relationship with Beckman Coulter. More articles by this author Giovanni Lughezzani Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy Financial interest and/or other relationship with Beckman Coulter. More articles by this author Stefano De Luca Department of Urology, Ospedale Gradenigo, Torino, Italy More articles by this author Roberto Passera Department of Urology, Ospedale Gradenigo, Torino, Italy More articles by this author Enrico Bollito Department of Urology, Ospedale Gradenigo, Torino, Italy More articles by this author Donato Randone Department of Urology, Ospedale Gradenigo, Torino, Italy More articles by this author Firas Abdollah Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy More articles by this author Umberto Capitanio Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy More articles by this author Alessandro Larcher Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy More articles by this author Giuliana Lista Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy More articles by this author Giulio Maria Gadda Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy More articles by this author Vittorio Bini Department of Internal Medicine, University of Perugia, Perugia, Italy More articles by this author Francesco Montorsi Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy More articles by this author Giorgio Guazzoni Department of Urology, University Vita-Salute, Scientific Institute H San Raffaele, Milan, Italy More articles by this author Expand All Advertisement PDF downloadLoading ...
Referência(s)