Prostate Cancer Screening PDF
Preview Prostate Cancer Screening
Prostate Cancer Screening Current Clinical Urology Eric A. Klein, MD, S E ERIES DITOR ProstateCancerScreening,SecondEdition,editedbyDonnaP.Ankerst,CatherineM.Tangen, IanM.Thompson,2009 UrologicRoboticSurgery,editedbyJeffreyA.Stock,MichaelP.Esposito,andVincentLanteri,2008 GenitourinaryPainandInflammation:DiagnosisandManagement,editedbyJeanetteM.Potts,2008 ProstateBiopsy:Indications,Techniques,andComplications,editedbyJ.StephenJones,2008 FemaleUrology:APracticalClinicalGuide,editedbyHowardGoldmanandSandipP.Vasavada,2007 UrinaryStoneDisease:ThePracticalGuidetoMedicalandSurgicalManagement,editedMarshallL.Stollerand MaxwellV.Meng,2007 PeyronieŠsDisease:AGuidetoClinicalManagement,editedbyLaurenceA.Levine,2006 MaleSexualFunction:AGuidetoClinicalManagement,SecondEdition,editedbyJohnJ.Mulcahy,2006 AdvancedEndourology:TheCompleteClinicalGuide,editedbyStephenY.NakadaandMargaretS.Pearle, 2005 Oral Pharmacotherapy of Male Sexual Dysfunction: A Guide to Clinical Management, edited by Gregory A. Broderick,2005 UrologicalEmergencies:APracticalGuide,editedbyHunterWessellsandJackW.McAninch,2005 ManagementofProstateCancer,SecondEdition,editedbyEricA.Klein,2004 EssentialUrology:AGuidetoClinicalPractice,editedbyJeannetteM.Potts,2004 ManagementofBenignProstaticHypertrophy,editedbyKevinT.McVary,2004 PediatricUrology,editedbyJohnP.Gearhart,2003 LaparoscopicUrologicOncology,editedbyJeffreyA.Cadeddu,2004 EssentialUrologicLaparoscopy:TheCompleteClinicalGuide,editedbyStephenY.Nakada,2003 UrologicProstheses:TheCompletePracticalGuidetoDevices,TheirImplantation,andPatientFollow-Up,edited byCulleyC.Carson,III,2002 MaleSexualFunction:AGuidetoClinicalManagement,editedbyJohnJ.Mulcahy,2001 ProstateCancerScreening,editedbyIanM.Thompson,MartinI.Resnick,andEricA.Klein,2001 BladderCancer:CurrentDiagnosisandTreatment,editedbyMichaelJ.Droller,2001 Prostate Cancer Screening Second Edition Edited by Donna P. Ankerst, Ph.D. Technical University, Garching, Germany and University of Texas Health Science Center at San Antonio, San Antonio, TX, USA Catherine M. Tangen, DrPh Fred Hutchinson Cancer Research Center, Seattle, WA, USA Ian M. Thompson Jr, MD University of Texas Health Science Center at San Antonio, San Antonio, TX, USA Editors DonnaP.Ankerst CatherineM.Tangen Professor,DepartmentofMathematics Member,SouthwestOncologyGroup TechnicalUniversity,Garching,Germany StatisticalCenter AssociateProfessor,Departments FredHutchinsonCancerResearchCenter ofUrology,andEpidemiology/Biostatistics Seattle,WA,USA UniversityofTexasHealthScienceCenter [email protected] atSanAntonio SanAntonio,TX,USA [email protected] IanM.Thompson ProfessorandChair,DepartmentofUrology UniversityofTexasHealthScienceCenter atSanAntonio SanAntonio,TX,USA [email protected] SeriesEditor EricA.Klein ProfessorofSurgery ClevelandClinicLernerCollege ofMedicine Head,SectionofUrologicOncology GlickmanUrologicaland KidneyInstitute Cleveland,OH,USA ISBN978-1-60327-280-3 e-ISBN978-1-60327-281-0 DOI10.1007/978-1-60327-281-0 LibraryofCongressControlNumber:2008943026 (cid:2)c HumanaPress,apartofSpringerScience+BusinessMedia,LLC2009 Allrightsreserved.Thisworkmaynotbetranslatedorcopiedinwholeorinpartwithoutthewrittenpermissionof thepublisher(HumanaPress,c/oSpringerScience+BusinessMedia,LLC,233SpringStreet,NewYork,NY10013, USA),exceptforbriefexcerptsinconnectionwithreviewsorscholarlyanalysis.Useinconnectionwithanyformof informationstorageandretrieval,electronicadaptation,computersoftware,orbysimilarordissimilarmethodologynow knownorhereafterdevelopedisforbidden. Theuseinthispublicationoftradenames,trademarks,servicemarks,andsimilarterms,eveniftheyarenotidentified assuch,isnottobetakenasanexpressionofopinionastowhetherornottheyaresubjecttoproprietaryrights. Whiletheadviceandinformationinthisbookarebelievedtobetrueandaccurateatthedateofgoingtopress,neither theauthorsnortheeditorsnorthepublishercanacceptanylegalresponsi-bilityforanyerrorsoromissionsthatmaybe made.Thepublishermakesnowarranty,expressorimplied,withrespecttothematerialcontainedherein. Printedonacid-freepaper springer.com Preface Weareenteringaremarkabletimeinmedicine.IntheUSAandothercountries,pre- ventive medicine and public health efforts have successfully increased life expectancy substantially;concurrently,thedemographicsofthepost-WorldWarIIpopulationtells usthattheover-50populationwilldramaticallyincreaseoverthenexttwodecades.As prostatecancerisdistinctlyage-related,wecananticipateatsunami-likeincreaseinthe numbers of patients with this disease. How will we respond to this challenge over the nexttwodecades? Between the early 1900s and the mid-1980s, about the only strategy against this diseasewasadigitalrectalexamination(DRE)withthegoalofearlydetectionandtreat- ment; if the disease was detected late, hormonal therapy was the mainstay of therapy. Unfortunately, systematic analyses of DRE as a screening tool found that the majority of cases detected were incurable by the time the tumor was palpable. In the case of hormonal therapy for advanced disease, 60 years after its discovery, average survival remainsonlyabout2–3years. With the discovery of PSA, a remarkable marker of prostate cancer risk, and with a national enthusiastic embrace of this test, the entire approach to this disease changed. Thenumberofdiagnosedprostatecancersmorethandoubledandthemajorityoftumors detected were organ-confined and probably cured. A man’s lifetime risk of prostate cancerdiagnosismorethandoubledfrom8%intheearly1980stoalmost18%today. When PSA first began to be used for screening in the early to mid-1980s, screening wasasimplematterforthepatientanddoctor:IfhisPSAwasabove4.0ng/mL,itwas abnormalandabiopsywasrecommended.Ifitwasbelow4.0ng/mL,itwasnormaland hewasreassuredthatallwaswell. We now know that this concept is not correct and that evaluating a man’s risk of prostate cancer is considerably more complex. PSA is not abnormal or normal but reflects a range of risk with each increase in level associated with an increased level ofrisk.WeknowthataPSAvalueinonepersonwithfewotherriskfactorsofprostate cancermeanssomethingcompletelydifferentthanthesamePSAvalueinanotherman who has other risk factors that increase his risk of cancer. Clinicians can no longer say “your PSA is normal” but instead must understand how to integrate other measures of riskaswellasunderstandwhentorequestotherscreeningtests.Theymustalsounder- standhowtoexplaintheseriskstotheirpatientswhohavebeenaccustomedto20years ofnormal/abnormalreadingsontheirPSAslips. Concurrentwithourunderstandingofthishasbeentheexplosionofnewbiomarkers and biomeasures of prostate cancer. We discriminate between the two terms, under- standingthata“biomarker”maybethemeasuredvalueofasubstanceinabodilyfluid orotherbiologicsamplewhilea“biomeasure”couldincludebodymassindex,number ofaffectedmalerelativeswithprostatecancer,orotherobservedandquantifiablevalues. Biomarker and biomeasure discovery has rapidly emerged as one of the primary focus areas in prostate cancer screening, with the hope of significantly improving benefits of v vi Preface screeningthroughmoreaccuratediagnosis.Thetranslationalendeavors,however,bring significanttechnologic,statisticalmethodologic,andclinicalchallenges. Thisbookincorporatesaseriesofthoughtfulandcutting-edgeworksfromtheworld’s expertsinprostatecancerscreening,rangingfromthecurrentstatusquoofprostatecan- cer screening across the globe, consensus on optimal utilization of the traditional PSA andDREtests,cutting-edgeresearchinnewbiomarkers,biomeasuresandextendedrisk algorithmsforprostatecancer,andlastbutnotleast,coverageoflargeongoinginterna- tional prevention and screening trials that aim to reduce prostate cancer mortality. The informationwillbehelpfulnotonlytotheclinicianwhoisfacedwithexplainingriskto the patient but also to the researcher who is developing new biomarkers, to the public health and policy decision-maker who is determining how screening should be imple- mented, as well as to current and future members of the biomarker industry who seek methodstobetterdevelopandsupportmarkersandmeasuresofprostatecancer. Weareindebtedtoourcolleaguesaroundtheworldwhohavecontributedtheirtime tothiswonderfultext.Thesearethescientistswhohavemadeandwillcontinuetomake discoveriesthatwillimpactthelivesofhundredsofmillionsofmenworldwideasthey facethemostcommoncancerinmen–canceroftheprostate. Contents Preface............................................................................. v Contributors........................................................................ xi ColorPlates........................................................................ xv PART I: TRENDS IN PROSTATE CANCER SCREENING 1 OverviewofUSProstateCancerTrendsintheEraofPSAScreening................ 3 RuthEtzioni,RomanGulati,andAngelaMariotto 2 TrendsinProstateCancerScreening:OverviewoftheUK.......................... 15 RichardJ.BryantandFreddieC.Hamdy 3 TrendsinProstateCancerScreening:Canada...................................... 23 RobertK.NamandLaurenceH.Klotz 4 TrendsinProstateCancerScreening–OverviewofEurope......................... 35 SanjaiK.AddlaandBobDjavan PART II: PROSTATE-SPECIFIC ANTIGEN 5 EvolutionofProstate-SpecificAntigenforScreening............................... 51 JavierHernandezandEdithCanby-Hagino 6 ThePerformanceCharacteristicsofProstate-SpecificAntigenforProstate CancerScreening............................................................ 61 IanM.Thompson,Jr.andDonnaP.Ankerst 7 ThePerformanceofPSAforPredictingProstateCancerAfteraPriorNegative ProstateBiopsy.............................................................. 71 CatherineM.Tangen 8 SubfractionsandDerivativesofTotalProstate-SpecificAntigenintheEarly DetectionofProstateCancer.................................................. 79 AlexanderHaeseandAlanW.Partin 9 PSAVelocityatPresentationasaPredictorofProstateCancerAggressiveness ....... 97 JasonA.EfstathiouandAnthonyV.D’Amico PART III: RISK ASSESSMENT FOR PROSTATE CANCER 10 NomogramsforProstateCancer.................................................117 ShahrokhF.ShariatandMichaelW.Kattan vii viii Contents 11 DecisionAidCriteriaandArtificialNeuralNetworksforOptimizingProstate CancerRiskPrediction.......................................................181 FelixK.-H.ChunandPierreI.Karakiewicz 12 DevelopmentoftheProstateCancerPreventionTrialProstateCancer RiskCalculator..............................................................195 DonnaP.AnkerstandIanM.Thompson 13 IntegrationofRiskAssessmentinProstateCancerScreening.......................205 KadeeEThompson,AmandaReed,andDipenJParekh 14 FamilyHistoryofProstateCancerDuringRapidlyIncreasingIncidence.............213 KariHemminkiandJustoLorenzoBermejo PART IV: RECENT BIOMARKERS FOR PROSTATE CANCER 15 PSAIsoforms:[−2]proPSASignificantAdjuncttoFreePSA.......................225 JeffreyE.Tam 16 PCA3.........................................................................233 JackGroskopf,JackSchalken,andHarryRittenhouse 17 TranscriptionalProfilingofProstateCancer:BiomarkerIdentification andClinicalApplications.....................................................243 NigelCleggandPeterS.Nelson 18 BiomarkersforProstateCancerDetection:Family-BasedLinkageAnalysis andCase–ControlAssociationStudies.........................................261 JokeBeutenandTeresaLJohnson-Pais 19 GSTP1HypermethylationforProstateCancerDetection............................279 RuiHenriqueandCarmenJerónimo 20 EPCAandEPCA-2asPotentialBiomarkersforProstateCancerDetection...........289 EddyS.LemanandRobertH.Getzenberg PART V: DESIGN AND METHODOLOGIC CONSIDERATIONS IN BIOMARKER STUDIES 21 TowardaRobustSystemforBiomarkerTriageandValidation–EDRN Experience..................................................................297 ZidingFeng,JacobKaganandSudhirSrivastava 22 StatisticalEvaluationofMarkersandRiskToolsforProstateCancer ClassificationandPrediction..................................................307 YingyeZhengandDonnaP.Ankerst 23 PitfallsinProstateCancerBiomarkerEvaluationStudies...........................319 DonnaP.Ankerst PART VI: BUILDING UPON RECENTLY COMPLETED AND ONGOING PROSPECTIVE TRIALS 24 Prostate-SpecificAntigenandItsRoleontheProstateCancerPreventionTrial........333 CatherineM.TangenandPhyllisJ.Goodman Contents ix 25 TheSeleniumandVitaminECancerPreventionTrial..............................349 EricA.Klein 26 PLCO:ARandomizedControlledScreeningTrialforProstate,Lung,Colorectal, andOvarianCancer..........................................................361 AmandaBlack,RobertL.GrubbIII,andE.DavidCrawford 27 TheEuropeanRandomizedStudyofScreeningforProstateCancer(ERSPC).........373 TinekeWoltersandFritzH.Schröder Index..............................................................................387 Contributors SANJAI K. ADDLA, FRCS •DepartmentofUrology,UniversityofBrussels,Erasme Hospital,UniversityClinicsofBrussels,Brussels,Belgium DONNA P. ANKERST, PHD •DepartmentofMathematics,TechnicalUniversity, Garching,Germany,andDepartmentsofUrology,andEpidemiology/Biostatistics, UniversityofTexasHealthScienceCenteratSanAntonio,SanAntonio,TX,USA JUSTO LORENZO BERMEJO, MD •DivisionofMolecularGeneticEpidemiology, GermanCancerResearchCenter,Heidelberg,Germany JOKE BEUTEN, PHD •DepartmentofCellularandStructuralBiology,TheUniversity ofTexasHealthScienceCenter,SanAntonio,TX,USA AMANDA BLACK, PHD •EarlyDetectionResearchGroup,DivisionofCancer Preventionand,theCancerPreventionFellowshipProgram,OfficeofPreventive Oncology,NationalCancerInstitute,Bethesda,MD,USA RICHARD J. BRYANT •LecturerinUrology,NuffieldDepartmentofSurgery,Fellow ofBalliol,UniversityofOxford,JohnRadcliffeHospital,OxfordOX39DU,United Kingdom EDITH CANBY-HAGINO, MD, MS •WilfordHallMedicalCenter,LacklandAFB,San Antonio,TX,USA FELIX K.-H. CHUN, MD •DepartmentofUrology,UniversityofHamburg,Germany NIGEL CLEGG, PHD •DivisionsofHumanBiologyandClinicalResearch,Fred HutchinsonCancerResearchCenter,Seattle,WA,USA E. DAVID CRAWFORD, MD •DivisionofUrology,UniversityofColoradoSchool ofMedicine,Denver,CO,USA ANTHONY V. D’AMICO, MD, PHD •DepartmentofRadiationOncology,Brigham& Women’sHospitalandDanaFarberCancerInstitute,HarvardMedicalSchool, Boston,MA,USA BOB DJAVAN MD, PHD •DepartmentofUrology,UniversityofBrussels,Erasme Hospital,UniversityClinicsofBrussels,Brussels,Belgium JASON A. EFSTATHIOU, MD, PHD •DepartmentofRadiationOncology,Brigham& Women’sHospitalandDanaFarberCancerInstitute,HarvardMedicalSchool, Boston,MA,USA RUTH ETZIONI, MD •FredHutchinsonCancerResearchCenter,Seattle,WA,USA ZIDING FENG, PHD •FredHutchinsonCancerResearchCenter,Seattle,WA,USA ROBERT H. GETZENBERG, PHD •TheBradyUrologicalInstitute,JohnsHopkins Hospital,Baltimore,MD,USA PHYLLIS J. GOODMAN, MS •SouthwestOncologyGroupStatisticalCenter,Fred HutchinsonCancerResearchCenter,Seattle,WA,USA JACK GROSKOPF, PHD •Gen-ProbeIncorporated,SanDiego,CA,USA ROBERT L. GRUBB III,MD•DivisionofUrologicSurgery,WashingtonUniversity,St. Louis,MO,USA ROMAN GULATI,MS•FredHutchinsonCancerResearchCenter,Seattle,Washington, USA xi
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