2023
Combination Treatment with Sipuleucel-T and Abiraterone Acetate or Enzalutamide for Metastatic Castration-Resistant Prostate Cancer: STAMP and STRIDE Trials
Antonarakis E, Subudhi S, Pieczonka C, Karsh L, Quinn D, Hafron J, Wilfehrt H, Harmon M, Sheikh N, Shore N, Petrylak D. Combination Treatment with Sipuleucel-T and Abiraterone Acetate or Enzalutamide for Metastatic Castration-Resistant Prostate Cancer: STAMP and STRIDE Trials. Clinical Cancer Research 2023, 29: 2426-2434. PMID: 37058234, PMCID: PMC10320463, DOI: 10.1158/1078-0432.ccr-22-3832.Peer-Reviewed Original ResearchConceptsMetastatic castration-resistant prostate cancerAndrogen receptor-targeted agentsMedian overall survivalCastration-resistant prostate cancerOverall survivalNational Death IndexConcurrent administrationProstate cancerAntigen-presenting cell activationCurrent prescribing informationNew safety signalsKaplan-Meier methodologyLong-term outcomesConfidence intervalsReceptor-targeted agentsProstatic acid phosphataseAbiraterone acetateFirst infusionDeath IndexPrescribing informationHumoral responseSubsequent infusionSequential administrationSafety signalsImmune response
2020
343 Phase 3 study of pembrolizumab + docetaxel and prednisone/prednisolone for metastatic castration-resistant prostate cancer (mCRPC) pretreated with next-generation hormonal agents (NHAs) (KEYNOTE-921)
Petrylak D, Shore N, Bennamoun M, Ratta R, Piulats J, Li B, Schloss C, Fizazi K. 343 Phase 3 study of pembrolizumab + docetaxel and prednisone/prednisolone for metastatic castration-resistant prostate cancer (mCRPC) pretreated with next-generation hormonal agents (NHAs) (KEYNOTE-921). Journal For ImmunoTherapy Of Cancer 2020, 8: a209-a210. DOI: 10.1136/jitc-2020-sitc2020.0343.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerNext-generation hormonal agentsPrednisone/prednisoloneProgression-free survivalObjective response rateDuration of responseSecondary end pointsOverall survivalDisease progressionResponse ratePrior treatmentRECIST v1.1End pointAbiraterone acetateEastern Cooperative Oncology Group performance status 0/1Prostate-specific antigen (PSA) response rateDual primary end pointsKey secondary end pointRadiographic progression-free survivalCastration-resistant prostate cancerPerformance status 0/1PSA response rateSubsequent anticancer therapyAndrogen deprivation therapyPrimary end pointPhase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone acetate (abi)–pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-921.
Petrylak D, Shore N, Bennamoun M, Ratta R, Piulats J, Li B, Schloss C, Fizazi K. Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone acetate (abi)–pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-921. Journal Of Clinical Oncology 2020, 38: tps262-tps262. DOI: 10.1200/jco.2020.38.6_suppl.tps262.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPrednisone/prednisoloneRECIST v1.1Prostate Cancer Working Group 3Castration-resistant prostate cancerEnd pointAdequate organ functionECOG PS 0Months of screeningPSA response rateSubsequent anticancer therapyAndrogen deprivation therapyPD-1 inhibitorsPrimary end pointSecondary end pointsSingle-agent antitumor activityPhase 3 trialPhase III studyDeprivation therapyPSA progressionUnacceptable toxicityAbiraterone acetateIII studyMetastasis locationPS 0
2017
A phase 1/1b multicenter, open-label, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, immunogenicity, and antitumor activity of MEDI3726 in patients with metastatic, castration-resistant prostate cancer who have received prior treatment with abiraterone or enzalutamide.
Fleming M, Cathomas R, Petrylak D, Wang J, Bander N, Zammarchi F, van Berkel P, Cho S, Elgeioushi N, Bothos J, Scheuber A, de Bono J. A phase 1/1b multicenter, open-label, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, immunogenicity, and antitumor activity of MEDI3726 in patients with metastatic, castration-resistant prostate cancer who have received prior treatment with abiraterone or enzalutamide. Journal Of Clinical Oncology 2017, 35: tps5088-tps5088. DOI: 10.1200/jco.2017.35.15_suppl.tps5088.Peer-Reviewed Original ResearchProstate-specific membrane antigenCastration-resistant prostate cancerDose-expansion studyAbiraterone acetateProstate cancerDose escalationAntitumor activityPrior treatmentTaxane-based chemotherapyDose-limiting toxicityFurther treatment optionsAnti-PSMA antibodyVivo antitumor activityTarget enrollmentTreatment optionsTherapeutic advancesPreclinical modelsPatientsMembrane antigenSecondary objectiveCancerMCRPCMulticenterTolerabilityExpression levels
2015
Phase 1/2 trial of cabazitaxel with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel and abiraterone acetate: Phase 2 results.
Mateo J, Fizazi K, Pezaro C, Loriot Y, Mehra N, Albiges L, Bianchini D, Varga A, Ryan C, Petrylak D, Shen L, Zhang J, Attard G, De Bono J, Massard C. Phase 1/2 trial of cabazitaxel with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel and abiraterone acetate: Phase 2 results. Journal Of Clinical Oncology 2015, 33: 268-268. DOI: 10.1200/jco.2015.33.7_suppl.268.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPhase 2 partProgression-free survivalAbiraterone acetateAdverse eventsPrimary endpointTreatment-emergent adverse eventsCastration-resistant prostate cancerECOG PS 0Median PSA-PFSPSA response rateAntitumor activityOpen-label trialDuration of responseCombination of abirateroneMeasurable diseasePSA-PFSRECIST 1.1Secondary endpointsDose intensityOverall survivalPartial responsePS 0PSA responseMedian time
2014
Phase 1b study of abiraterone acetate (AA) and docetaxel (D) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).
Tagawa S, Posadas E, Bruce J, Lim E, Petrylak D, Peng W, Maul R, Smit H, Tran N, Nanus D. Phase 1b study of abiraterone acetate (AA) and docetaxel (D) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2014, 32: 5025-5025. DOI: 10.1200/jco.2014.32.15_suppl.5025.Peer-Reviewed Original ResearchA randomized open-label phase 2a study evaluating the efficacy and safety of radium-223 dichloride (Ra-223) in combination with abiraterone acetate or enzalutamide in patients with castration-resistant prostate cancer (CRPC) and bone metastases.
Petrylak D, Rosenberg J, Garosi V, Siegel J, Goldin J. A randomized open-label phase 2a study evaluating the efficacy and safety of radium-223 dichloride (Ra-223) in combination with abiraterone acetate or enzalutamide in patients with castration-resistant prostate cancer (CRPC) and bone metastases. Journal Of Clinical Oncology 2014, 32: tps5103-tps5103. DOI: 10.1200/jco.2014.32.15_suppl.tps5103.Peer-Reviewed Original ResearchEvaluating the safety of abiraterone acetate (AA) and docetaxel (D) administered in combination in patients (Pts) with metastatic castration-resistant prostate cancer (mCRPC).
Tagawa S, Nanus D, Posadas E, Petrylak D, Bruce J, Lim E, Peng W, Maul R, Gonzalez M, Tran N. Evaluating the safety of abiraterone acetate (AA) and docetaxel (D) administered in combination in patients (Pts) with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2014, 32: 205-205. DOI: 10.1200/jco.2014.32.4_suppl.205.Peer-Reviewed Original ResearchDose-limiting toxicityMetastatic castration-resistant prostate cancerAbiraterone acetateExperienced dose-limiting toxicityProstate-specific antigen (PSA) declineCastration-resistant prostate cancerPhase Ib studyMaximum plasma concentrationConcentration-time curveIntolerable toxicityPSA progressionMedian timeSystemic exposurePlasma concentrationsProstate cancerIb studyPharmacokinetic parametersFurther evaluationWk 2Wk 7CohortToxicityComplementary mechanismsProportion of PtSafety