2017
Sipuleucel-T (sip-T) to induce cytolytic T lymphocyte (CTL) activity against target antigens in men with hormone-sensitive and castration-resistant prostate cancer (CRPC).
Drake C, Antonarakis E, Petrylak D, Quinn D, Kibel A, Chang N, Dearstyne E, Campogan D, Haynes H, Vu T, Sheikh N, Small E. Sipuleucel-T (sip-T) to induce cytolytic T lymphocyte (CTL) activity against target antigens in men with hormone-sensitive and castration-resistant prostate cancer (CRPC). Journal Of Clinical Oncology 2017, 35: 5046-5046. DOI: 10.1200/jco.2017.35.15_suppl.5046.Peer-Reviewed Original ResearchCastration-resistant prostate cancerPeripheral blood mononuclear cellsCTL lytic activityCD107a expressionOverall survivalT cellsImmune responseSymptomatic metastatic castration-resistant prostate cancerMetastatic castration-resistant prostate cancerCytolytic T lymphocyte activityAntigen-specific cellular responsesAutologous cellular immunotherapyGreater CTL activityHealthy donor controlsRobust CTL responsesT lymphocyte activityCD8 T cellsLonger overall survivalAntigen-specific proliferationBlood mononuclear cellsHumoral immune responseLytic activityOS benefitMCRPC patientsMetastatic CRPC
2014
774P Stride, a Randomized, Phase 2, Open-Label Study of Sipuleucel-T with Concurrent Vs Sequential Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (Mcrpc)
Petrylak D, Quinn D, Dreicer R, Antonarakis E, Shore N, Corman J, Concepcion R, Pieczonka C, Stubbs A, Sheikh N, Devries T, Sandler A, Drake C. 774P Stride, a Randomized, Phase 2, Open-Label Study of Sipuleucel-T with Concurrent Vs Sequential Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (Mcrpc). Annals Of Oncology 2014, 25: iv266. DOI: 10.1093/annonc/mdu336.22.Peer-Reviewed Original ResearchAdverse eventsArm ABristol-Myers SquibbArm B.Immune responsePeripheral T-cell immune responseMetastatic castration-resistant prostate cancerCastration-resistant prostate cancerElevated serum PSA levelsT cell immune responsesAutologous cellular immunotherapyTreatment of mCRPCTreatment-related gradePeripheral immune responsePhase 2 studySerum PSA levelsAndrogen receptor inhibitorMultiple treatment optionsCell immune responsesSecondary endpointsPrimary endpointPSA levelsInfusion 2Cellular immunotherapyInfusion 1
2013
Immune response with sipuleucel-T in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Phase II ProACT study.
Gardner T, Petrylak D, Corman J, Hall S, Weinstein R, Keyser R, Sims R, Sanders A, Sheikh N, Higano C. Immune response with sipuleucel-T in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Phase II ProACT study. Journal Of Clinical Oncology 2013, 31: 148-148. DOI: 10.1200/jco.2013.31.6_suppl.148.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerSymptomatic metastatic castration-resistant prostate cancerMemory B cellsImmune responseOverall survivalB cellsOngoing phase 2 studyCastration-resistant prostate cancerAutologous cellular immunotherapyPeripheral immune responsePhase 2 studyProlongs overall survivalST infusionCellular immunotherapySerum antiMemory phenotypeSipuleucelPA2024Prostate cancerCSF titersActivation phenotypeAnti-GMGM-CSFFlow cytometryMature phenotypeRelationship of sipuleucel-T with time to first use of opioid analgesics (TFOA) in patients (pts) with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC) on the IMPACT trial.
Small E, Higano C, Kantoff P, Whitmore J, Frohlich M, Petrylak D. Relationship of sipuleucel-T with time to first use of opioid analgesics (TFOA) in patients (pts) with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC) on the IMPACT trial. Journal Of Clinical Oncology 2013, 31: 74-74. DOI: 10.1200/jco.2013.31.6_suppl.74.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerSymptomatic metastatic castration-resistant prostate cancerCase report formsProtocol amendmentMedical reviewIMPACT trialCastration-resistant prostate cancerPrespecified secondary end pointsEnd pointECOG performance status 1Autologous cellular immunotherapyAverage pain scoreOpioid analgesic usePlacebo-treated patientsSecondary end pointsIndependent baseline predictorsPerformance status 1Objective disease progressionVisual analog scaleCox regression modelKaplan-Meier estimatesAsymptomatic ptsPrimary radiotherapyAnalgesic useCancer pain
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 upregulation