2023
Synthesizing and Applying Molecular Targeted Imaging Results in Patients With Prostate Cancer (RADAR VII)
Crawford E, Harris R, Slovin S, Concepcion R, Albala D, Gomella L, Orio P, Sellinger S, Petrylak D, Koo P. Synthesizing and Applying Molecular Targeted Imaging Results in Patients With Prostate Cancer (RADAR VII). JU Open Plus 2023, 1 DOI: 10.1097/ju9.00000000000000011.Peer-Reviewed Original ResearchProstate cancerNonmetastatic castrate-resistant prostate cancerClinical decisionCastrate-resistant prostate cancerConventional imagingLimited clinical dataTreatment of patientsFuture clinical trialsTreatment decision makingProstate cancer researchLimited available evidenceNuclear medicine specialistsLocalized diseaseMetastatic diseaseMedical oncologistsProspective studyBiochemical recurrenceClinical trialsRadiographic assessmentClinical dataMore robust recommendationsMedicine specialistsClinical experienceConsensus guidanceRadiation oncologists
2021
Sacituzumab govitecan, a Trop-2-directed antibody-drug conjugate, for patients with epithelial cancer: final safety and efficacy results from the phase I/II IMMU-132-01 basket trial
Bardia A, Messersmith WA, Kio EA, Berlin JD, Vahdat L, Masters GA, Moroose R, Santin AD, Kalinsky K, Picozzi V, O'Shaughnessy J, Gray JE, Komiya T, Lang JM, Chang JC, Starodub A, Goldenberg DM, Sharkey RM, Maliakal P, Hong Q, Wegener WA, Goswami T, Ocean AJ. Sacituzumab govitecan, a Trop-2-directed antibody-drug conjugate, for patients with epithelial cancer: final safety and efficacy results from the phase I/II IMMU-132-01 basket trial. Annals Of Oncology 2021, 32: 746-756. PMID: 33741442, DOI: 10.1016/j.annonc.2021.03.005.Peer-Reviewed Original ResearchConceptsOverall safety populationAdverse eventsSacituzumab govitecanAntibody-drug conjugatesEpithelial cancersFebrile neutropeniaMost common treatment-related adverse eventsPhase I/II multicenter trialCommon treatment-related adverse eventsTreatment-related serious adverse eventsTrophoblast cell surface antigen 2Castrate-resistant prostate cancer patientsTreatment-related adverse eventsCastrate-resistant prostate cancerSmall cell lung cancerCell surface antigen 2Clinical benefit rateTreatment-related deathsObjective response rateSerious adverse eventsProgression-free survivalDuration of responseAdvanced epithelial cancersProstate cancer patientsSmall cell lung
2020
First-in-human phase I study of ARV-110, an androgen receptor (AR) PROTAC degrader in patients (pts) with metastatic castrate-resistant prostate cancer (mCRPC) following enzalutamide (ENZ) and/or abiraterone (ABI).
Petrylak D, Gao X, Vogelzang N, Garfield M, Taylor I, Dougan Moore M, Peck R, Burris H. First-in-human phase I study of ARV-110, an androgen receptor (AR) PROTAC degrader in patients (pts) with metastatic castrate-resistant prostate cancer (mCRPC) following enzalutamide (ENZ) and/or abiraterone (ABI). Journal Of Clinical Oncology 2020, 38: 3500-3500. DOI: 10.1200/jco.2020.38.15_suppl.3500.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerAST/ALTAdverse eventsPSA responseAnti-tumor activityPrior therapyAST/ALT elevationElevated AST/ALTCastrate-resistant prostate cancerProstate cancer xenograft modelPreclinical anti-tumor activityPhase 2 doseRECIST partial responseAcceptable safety profileAcute renal failureHuman phase ICancer xenograft modelPrior chemotherapyALT elevationData cutoffRenal failurePartial responseDose escalationRadium-223Enz resistanceA comparison of sipuleucel-T (sip-T) product parameters from two phase III studies: PROVENT in active surveillance prostate cancer and IMPACT in metastatic castrate-resistant prostate cancer (mCRPC).
Ross A, Armstrong A, Pieczonka C, Bailen J, Tutrone R, Cooperberg M, Pavlovich C, Renzulli J, Haynes H, Sheikh N, Shore N. A comparison of sipuleucel-T (sip-T) product parameters from two phase III studies: PROVENT in active surveillance prostate cancer and IMPACT in metastatic castrate-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2020, 38: 321-321. DOI: 10.1200/jco.2020.38.6_suppl.321.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerCD54 upregulationProstate cancerOverall survivalActive surveillanceCell countCastrate-resistant prostate cancerPeripheral blood mononuclear cellsEarly-stage prostate cancerAutologous cellular immunotherapyLarger immune responsesPhase III studyBlood mononuclear cellsStage prostate cancerTotal nucleated cell countNucleated cell countIII studyCellular immunotherapyMononuclear cellsTreatment weekProstate adenocarcinomaT cellsImmune responseTNC countProvent
2018
842P CTC-based biomarkers & PSMA-targeted imaging in patients with metastatic castrate-resistant prostate cancer (mCRPC)
Morris M, Vogelzang N, Sartor O, Armour A, Messmann R, Groaning M, Robarts A, Tolcher A, Gordon M, Babiker H, Kuo P, Kearney M, Jendrisak A, Wang Y, Landers M, Petrylak D. 842P CTC-based biomarkers & PSMA-targeted imaging in patients with metastatic castrate-resistant prostate cancer (mCRPC). Annals Of Oncology 2018, 29: viii294. DOI: 10.1093/annonc/mdy284.051.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerCastrate-resistant prostate cancerProstate cancerPatientsCancerBiomarkersSmall molecule activators of protein phosphatase 2A for the treatment of castration-resistant prostate cancer.
McClinch K, Avelar R, Callejas D, Izadmehr S, Wiredja D, Perl A, Sangodkar J, Kastrinsky D, Schlatzer D, Cooper M, Kiselar J, Stachnik A, Yao S, Hoon D, McQuaid D, Zaware N, Gong Y, Brautigan D, Plymate S, Sprenger C, Oh W, Levine A, Kirschenbaum A, Sfakianos J, Sears R, DiFeo A, Ioannou Y, Ohlmeyer M, Narla G, Galsky M. Small molecule activators of protein phosphatase 2A for the treatment of castration-resistant prostate cancer. Cancer Research 2018, 78: canres.0123.2017. PMID: 29358171, PMCID: PMC5899650, DOI: 10.1158/0008-5472.can-17-0123.Peer-Reviewed Original ResearchConceptsCastrate-resistant prostate cancerAndrogen receptorProstate cancerCRPC cellsHuman castrate-resistant prostate cancerMultiple oncogenic signaling pathwaysSmall molecule activatorsAndrogen deprivation therapyAdvanced prostate cancerPrimary prostate cancerMurine xenograft modelGrowth inhibitory effectsDeprivation therapyCRPC treatmentTime-dependent mannerOncogenic signaling pathwaysPreclinical proofXenograft modelAR degradationCancer ResTumor suppressor PP2ATumor formationCancerAberrant reactivationSignaling pathwaysPSMA heterogeneity analysis in patients with metastatic castrate-resistant prostate cancer (mCRPC): Imaging versus CTCs.
Morris M, Vogelzang N, Sartor A, Armour A, Messmann R, Groaning M, Robarts A, Tolcher A, Gordon M, Babiker H, Kuo P, Kearney M, Jendrisak A, Wang Y, Landers M, Petrylak D. PSMA heterogeneity analysis in patients with metastatic castrate-resistant prostate cancer (mCRPC): Imaging versus CTCs. Journal Of Clinical Oncology 2018, 36: 272-272. DOI: 10.1200/jco.2018.36.6_suppl.272.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerProstate-specific membrane antigenSPECT/CT scansHomologous recombination deficiency scoresPSMA expressionProstate cancerCT scanPre-treatment blood samplesDeficiency scoresCastrate-resistant prostate cancerBiomarker analysisSoft tissue lesionsSPECT/CTTherapeutic predictive valueDetectable CTCsNaïve patientsBone scanBad respondersClinical outcomesBaseline CTBone lesionsPositive lesionsBlood samplesTissue lesionsTherapeutic target
2017
793PD Phase 1 study of the PSMA-targeted small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC)
Morris M, Vogelzang N, Sartor O, Armour A, Groaning M, Messmann R, Robarts A, Petrylak D, Tolcher A, Gordon M, Babiker H. 793PD Phase 1 study of the PSMA-targeted small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC). Annals Of Oncology 2017, 28: v273. DOI: 10.1093/annonc/mdx370.010.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerCastrate-resistant prostate cancerPhase 1 studyProstate cancerSmall molecule drugsPatientsCancerPhase 1 study of the PSMA-targeted small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Morris M, Vogelzang N, Sartor O, Armour A, Groaning M, Robarts A, Petrylak D, Tolcher A, Gordon M, Babiker H. Phase 1 study of the PSMA-targeted small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2017, 35: 5038-5038. DOI: 10.1200/jco.2017.35.15_suppl.5038.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerProstate-specific membrane antigenRadiographic progression-free survivalProstate cancerMedian radiographic progression-free survivalCastrate-resistant prostate cancerProgression-free survivalPhase 1 studySoft tissue diseasePatient selection toolPotential therapeutic targetAnti-tumor activityB ptsMost normal tissuesG3 thrombocytopeniaExpansion cohortPrimary endpointDose escalationMedian ageTissue diseaseRadiographic assessmentMedian numberDisease localizationDose reductionPart B
2016
The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of prostate carcinoma
McNeel DG, Bander NH, Beer TM, Drake CG, Fong L, Harrelson S, Kantoff PW, Madan RA, Oh WK, Peace DJ, Petrylak DP, Porterfield H, Sartor O, Shore ND, Slovin SF, Stein MN, Vieweg J, Gulley JL. The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of prostate carcinoma. Journal For ImmunoTherapy Of Cancer 2016, 4: 92. PMID: 28031820, PMCID: PMC5170901, DOI: 10.1186/s40425-016-0198-x.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerLate-stage clinical trialsProstate cancer patientsProstate cancerCancer patientsClinical trialsAutologous dendritic cell vaccineCastrate-resistant prostate cancerCancer consensus statementUse of immunotherapyDendritic cell vaccinesAdvanced prostate cancerResistant prostate cancerImmunotherapy of cancerMonitoring of patientsSystematic literature searchAnti-cancer treatmentImmunotherapy evolvesCell vaccinePotential immunotherapyPatient selectionImmunotherapeutic agentsTherapeutic optionsCancer deathCancer immunotherapy731P Phase 1 study of the PSMA-targeted tubulysin small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC): Study update
Morris M, Vogelzang N, Sartor O, Armour A, Petrylak D, Tolcher A, Ejadi S, Babiker H. 731P Phase 1 study of the PSMA-targeted tubulysin small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC): Study update. Annals Of Oncology 2016, 27: vi249. DOI: 10.1093/annonc/mdw372.15.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerCastrate-resistant prostate cancerPhase 1 studyProstate cancerSmall molecule drugsStudy updatePatientsCancerαvβ6 Integrin Promotes Castrate-Resistant Prostate Cancer through JNK1-Mediated Activation of Androgen Receptor
Lu H, Wang T, Li J, Fedele C, Liu Q, Zhang J, Jiang Z, Jain D, Iozzo RV, Violette SM, Weinreb PH, Davis RJ, Gioeli D, FitzGerald TJ, Altieri DC, Languino LR. αvβ6 Integrin Promotes Castrate-Resistant Prostate Cancer through JNK1-Mediated Activation of Androgen Receptor. Cancer Research 2016, 76: 5163-5174. PMID: 27450452, PMCID: PMC5012867, DOI: 10.1158/0008-5472.can-16-0543.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntigens, NeoplasmCell Line, TumorDisease Models, AnimalFlow CytometryFluorescent Antibody TechniqueGene Knockdown TechniquesHumansImmunohistochemistryIntegrinsMaleMiceMice, KnockoutMitogen-Activated Protein Kinase 8Prostatic Neoplasms, Castration-ResistantReceptors, AndrogenSignal TransductionConceptsΑvβ6 expressionAndrogen receptorProstate cancerΑvβ6 integrinCastrate-resistant prostate cancerProstate cancer mouse modelAbsence of androgenFurther clinical developmentProstate cancer therapyCancer mouse modelNormal prostatic epitheliumProstate cancer progressionΑv-containing integrinsMajor therapeutic targetUpregulation of survivinActivation of JNK1Androgen ablationDownstream kinase activationMechanisms of resistanceProstatic adenocarcinomaInvolvement of p38Preclinical resultsMouse modelProstatic epitheliumClinical developmentPhase 1 study of the PSMA-targeted tubulysin small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Morris M, Petrylak D, Sartor A, Vogelzang N, Groaning M, Ejadi S, Tolcher A, Babiker H. Phase 1 study of the PSMA-targeted tubulysin small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2016, 34: 2586-2586. DOI: 10.1200/jco.2016.34.15_suppl.2586.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerCastrate-resistant prostate cancerPhase 1 studyProstate cancerSmall molecule drugsPatientsCancerImmunogenicity of sipuleucel-T (Sip-T) in abiraterone (Abi)/enzalutamide (Enz) sensitive and resistant metastatic castrate-resistant prostate cancer (mCRPC).
Small E, Fong L, Quinn D, Drake C, Campogan D, Vu T, Sheikh N, Chang N, Petrylak D. Immunogenicity of sipuleucel-T (Sip-T) in abiraterone (Abi)/enzalutamide (Enz) sensitive and resistant metastatic castrate-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2016, 34: 5077-5077. DOI: 10.1200/jco.2016.34.15_suppl.5077.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerCastrate-resistant prostate cancerProstate cancerSipuleucelAbirateroneCancerImmunogenicityDocetaxel in Advanced and Castration Resistant Prostate Cancer
Petrylak D, Hafez N. Docetaxel in Advanced and Castration Resistant Prostate Cancer. 2016, 77-92. DOI: 10.1007/978-3-319-31341-2_6.Peer-Reviewed Original ResearchResistant prostate cancerProstate cancerMetastatic castrate-resistant prostate cancerCastrate-resistant metastatic diseaseMetastatic castrate-resistant diseaseCastration-resistant prostate cancerCastrate-resistant prostate cancerResistant metastatic diseaseCastrate-resistant diseasePrimary chemotherapeutic agentStandard of careDocetaxel useTaxane cabazitaxelMetastatic diseaseDocetaxel efficacyRandomized trialsResistant diseaseLocal diseaseSuperior survivalDocetaxelChemotherapeutic agentsCancerDiseaseCorticosteroidsCabazitaxelChapter 57 Second-Line Hormonal for Castrate-Resistant Prostate Cancer
Parihar J, Kim I. Chapter 57 Second-Line Hormonal for Castrate-Resistant Prostate Cancer. 2016, 533-540. DOI: 10.1016/b978-0-12-800077-9.00057-8.Peer-Reviewed Original ResearchCastrate-resistant prostate cancerProstate cancerHormonal manipulationHormone-sensitive prostate cancerSecond-line hormonal manipulationsSecond-line hormonal therapySecond-line treatment optionAssociated response ratesInitial systemic therapySecondary hormonal manipulationsSecond-generation antiandrogensFirst-generation antiandrogensAntiandrogen withdrawalARN-509Hormonal therapyMainstay treatmentAbiraterone acetateAndrogen suppressionSystemic therapyAndrogen deprivationSuch patientsTreatment optionsTherapeutic responseDisease progressionResponse rate
2014
Biomarker development trial of satraplatin in patients with metastatic castrate-resistant prostate cancer.
Liaw B, Seng S, Galsky M, Tsao C, Febbo P, Oh W. Biomarker development trial of satraplatin in patients with metastatic castrate-resistant prostate cancer. Journal Of Clinical Oncology 2014, 32: 170-170. DOI: 10.1200/jco.2014.32.4_suppl.170.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerProstate-specific antigenCastrate-resistant prostate cancerOverall survivalProstate cancerPredictive biomarkersMedian time to PSA progressionTime to PSA progressionSerum prostate-specific antigenLesions prior to treatmentDevelopment of predictive biomarkersDays 1 to 5Drug-related gradeMetastatic tumor biopsiesOral platinum analogueGleason score 8Biomarker developmentImage-guided biopsyImproved overall survivalPre-treatment biopsiesLong natural historyMetastatic tissue samplesPeripheral blood samplesAnti-tumor activityMCRPC patients
2013
A model for predicting overall survival in men with metastatic castrate-resistant prostate cancer (CRPC) for whom first-line chemotherapy failed.
Halabi S, Lin C, Small E, Armstrong A, Kaplan E, Petrylak D, Sternberg C, Shen L, Oudard S, De Bono J, Sartor A. A model for predicting overall survival in men with metastatic castrate-resistant prostate cancer (CRPC) for whom first-line chemotherapy failed. Journal Of Clinical Oncology 2013, 31: 24-24. DOI: 10.1200/jco.2013.31.6_suppl.24.Peer-Reviewed Original ResearchFirst-line chemotherapyCastrate-resistant prostate cancerMedian overall survivalOverall survivalLow-risk groupRisk groupsPrognostic modelHazard ratioMetastatic castrate-resistant prostate cancerECOG performance statusPhase III trialsImportant prognostic factorProstate-specific antigenTime-dependent areaTime-dependent AUCDocetaxel useMCRPC settingMeasurable diseaseIII trialsPerformance statusProgressive diseaseVisceral diseasePrognostic factorsHormonal useClinical trials
2012
943P Openact: Phase 2, Open-Label Study of Sipuleucel-T in Metastatic Castrate-Resistant Prostate Cancer (MCRPC)
Corman J, Dawson N, Hall S, Nabhan C, Ferrari A, Armstrong A, Murdock M, Stewart F, Sheikh N, Petrylak D. 943P Openact: Phase 2, Open-Label Study of Sipuleucel-T in Metastatic Castrate-Resistant Prostate Cancer (MCRPC). Annals Of Oncology 2012, 23: ix311. DOI: 10.1016/s0923-7534(20)33504-3.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerTotal nucleated cell countImmune responseHigher baseline prostate-specific antigenPhase 2 open-label studyCell countBaseline prostate-specific antigenAntigen-specific immune responsesCastrate-resistant prostate cancerT cell proliferative responsesAutologous cellular immunotherapyCostimulatory molecules CD54Sipuleucel-T treatmentOpen-label studySpeakers bureauHigher total nucleated cell countSanofi-AventisVirginia Mason Medical CenterRisk of deathCell proliferative responsesProstate-specific antigenNucleated cell countD exposureBristol-Myers SquibbCD54 upregulationLBA24 A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone (DP) with or without Lenalidomide (LEN) in Patients with Castrate-Resistant Prostate Cancer (CRPC): The Mainsail Trial
Petrylak D, Fizazi K, Sternberg C, Budnik N, De Wit R, Wiechno P, Bellmunt J, Barton D, Fandi A, Jungnelius U, Li S, Vogelzang N. LBA24 A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone (DP) with or without Lenalidomide (LEN) in Patients with Castrate-Resistant Prostate Cancer (CRPC): The Mainsail Trial. Annals Of Oncology 2012, 23: ixe15. DOI: 10.1016/s0923-7534(20)34329-5.Peer-Reviewed Original ResearchCastrate-resistant prostate cancerProgression-free survivalDP armOverall survivalProgressive metastatic castrate-resistant prostate cancerMetastatic castrate-resistant prostate cancerMethods Chemotherapy-naïve patientsAddition of lenalidomideLower dose intensitySafety of docetaxelSafety of lenalidomideChemotherapy-naïve patientsEarly treatment discontinuationMedian overall survivalObjective response rateECOG PS scoreFirst-line treatmentPhase 1/2 trialShorter treatment durationPhase 3Lack of benefitFebrile neutropeniaMAINSAIL trialNeutropenic sepsisPrimary endpoint
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