2021
CheckMate 9KD cohort A1 final analysis: Nivolumab (NIVO) + rucaparib for post-chemotherapy (CT) metastatic castration-resistant prostate cancer (mCRPC).
Pachynski R, Retz M, Goh J, Burotto M, Gravis G, Castellano D, Flechon A, Zschaebitz S, Shaffer D, Limon J, Grimm M, McCune S, Amin N, Li J, Wang X, Unsal-Kacmaz K, Saad F, Petrylak D, Fizazi K. CheckMate 9KD cohort A1 final analysis: Nivolumab (NIVO) + rucaparib for post-chemotherapy (CT) metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2021, 39: 5044-5044. DOI: 10.1200/jco.2021.39.15_suppl.5044.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerTreatment-related AEsObjective response rateRadiographic progression-free survivalCohorts A1Overall survivalDisease progression/unacceptable toxicityProstate-specific antigen (PSA) response rateResponse rateProgression/unacceptable toxicityCastration-resistant prostate cancerNovel hormonal therapiesSecondary efficacy resultsProgression-free survivalNew safety signalsPhase 2 trialPD-L1 upregulationPlausible therapeutic strategyPARP inhibitor treatmentMeasurable diseaseVisceral metastasesHormonal therapySecondary endpointsUnacceptable toxicityEvaluable tumorsPhase I study of AMG 509, a STEAP1 x CD3 T-cell recruiting XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC).
Kelly W, Pook D, Appleman L, Waterhouse D, Horvath L, Edenfield W, Matsubara N, Danila D, Aggarwal R, Petrylak D, Sartor A, Sumey C, Adra N, Armstrong A, Cheng F, Stieglmaier J, Kouros-Mehr H, Dorff T. Phase I study of AMG 509, a STEAP1 x CD3 T-cell recruiting XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2021, 39: tps183-tps183. DOI: 10.1200/jco.2021.39.6_suppl.tps183.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerFirst doseImmune therapyProstate cancerECOG performance status 0Prostate-specific antigen (PSA) responseCastration-resistant prostate cancerT cell-mediated lysisDose-expansion phasePerformance status 0Phase 2 doseObjective tumor responseT effector cellsASCO Annual MeetingTotal serum testosteroneLogistic regression modelsCell surface antigensTransmembrane epithelial antigenTumor cell responseCNS metastasisLeptomeningeal diseaseRECIST 1.1Status 0Taxane regimensHormonal therapy
2020
Phase I study of AMG 509, a STEAP1 x CD3 T cell-recruiting XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC).
Kelly W, Danila D, Edenfield W, Aggarwal R, Petrylak D, Sartor A, Sumey C, Dorff T, Yu E, Adra N, Waterhouse D, Armstrong A, Horvath L, Pook D, Appleman L, Lau A, Salvati M, Kouros-Mehr H. Phase I study of AMG 509, a STEAP1 x CD3 T cell-recruiting XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2020, 38: tps5589-tps5589. DOI: 10.1200/jco.2020.38.15_suppl.tps5589.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerFirst doseImmune therapyProstate cancerECOG performance status 0Prostate-specific antigen (PSA) responseCastration-resistant prostate cancerT cell-mediated lysisPhase IDose-expansion phasePerformance status 0Objective tumor responsePhase II doseT effector cellsTotal serum testosteroneLogistic regression modelsCell surface antigensTransmembrane epithelial antigenTumor cell responseCNS metastasisLeptomeningeal diseaseRECIST 1.1Status 0Taxane regimensHormonal therapy
2012
A phase III, randomized, double-blind, multicenter trial comparing the investigational agent orteronel (TAK-700) plus prednisone (P) with placebo plus P in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or following docetaxel-based therapy.
Dreicer R, Agus D, Bellmunt J, De Bono J, Petrylak D, Tejura B, Shi Y, Fizazi K. A phase III, randomized, double-blind, multicenter trial comparing the investigational agent orteronel (TAK-700) plus prednisone (P) with placebo plus P in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or following docetaxel-based therapy. Journal Of Clinical Oncology 2012, 30: tps4693-tps4693. DOI: 10.1200/jco.2012.30.15_suppl.tps4693.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerDisease progressionRadiographic progression-free survivalProstate-specific antigen levelCastration-resistant prostate cancerChemotherapy-naïve menDocetaxel-based therapyPhase 1/2 studyPhase 3 studyProgression-free survivalPatient-reported outcomesNew therapeutic optionsTestosterone synthesis pathwayERG fusion geneBone painMedical castrationNoncurative therapyHormonal therapyPrimary endpointPSA decreasePSA progressionStudy drugMetastatic diseaseObjective responseOverall survival
2002
Chemotherapy for the Treatment of Hormone-Refractory Prostate Cancer
Petrylak D. Chemotherapy for the Treatment of Hormone-Refractory Prostate Cancer. European Urology Open Science 2002, 1: 15-23. DOI: 10.1016/s1569-9056(02)00005-2.Peer-Reviewed Original ResearchHormone-refractory prostate cancerBone painProstate cancerSerum prostate-specific antigen levelProstate-specific antigen levelPhase II trialPhase III trialsSoft tissue metastasesAndrogen ablation therapyEffective palliative therapyAdvanced prostate cancerCombination of mitoxantroneMetastatic prostate cancerTreatment of menHormonal therapyII trialIII trialsOverall survivalPalliative therapyPSA levelsTissue metastasesAntigen levelsTreatment optionsClinical trialsAblation therapy