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 resistance
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 cancerPatientsCancerBiomarkersPSMA 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
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
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 updatePatientsCancerPhase 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 agentsCancerDiseaseCorticosteroidsCabazitaxel
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 endpoint123 Time to disease-related pain (TDRP) following sipuleucel-T in asymptomatic patients with metastatic castrate-resistant prostate cancer (mCRPC): Integrated results from three randomized phase 3 trials
Small E, Higano C, Kantoff P, Whitmore J, Frohlich M, Petrylak D. 123 Time to disease-related pain (TDRP) following sipuleucel-T in asymptomatic patients with metastatic castrate-resistant prostate cancer (mCRPC): Integrated results from three randomized phase 3 trials. European Urology Open Science 2012, 11: e123-e123a. DOI: 10.1016/s1569-9056(12)60122-5.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerRandomized phase 3 trialCastrate-resistant prostate cancerPhase 3 trialDisease-related painAsymptomatic patientsProstate cancerSipuleucelPainPatientsCancerTrials