2021
Efficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) in men with de novo (M1) metastatic hormone-sensitive prostate cancer (mHSPC) versus progression to mHSPC (M0): Post hoc analysis of the phase III ARCHES trial.
Azad A, Villers A, Alekseev B, Szmulewitz R, Alcaraz A, Shore N, Petrylak D, Holzbeierlein J, Gomez-Veiga F, Rosbrook B, Zohren F, Lee H, Haas G, Iguchi T, Stenzl A, Armstrong A. Efficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) in men with de novo (M1) metastatic hormone-sensitive prostate cancer (mHSPC) versus progression to mHSPC (M0): Post hoc analysis of the phase III ARCHES trial. Journal Of Clinical Oncology 2021, 39: 102-102. DOI: 10.1200/jco.2021.39.6_suppl.102.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerEfficacy of enzalutamideAndrogen deprivation therapyDe novo metastatic hormone-sensitive prostate cancerM1 diseaseInitial diagnosisProstate-specific antigenSecondary endpointsDisease volumeTreatment armsHormone-sensitive prostate cancerProgression-free survival eventsPrior docetaxel useKey secondary endpointNew antineoplastic therapiesDeprivation therapyDocetaxel usePrior docetaxelEfficacy outcomesPrimary endpointPSA progressionBaseline characteristicsObjective responseClinical benefitSafety profile
2019
Phase III study of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): The ARCHES trial.
Armstrong A, Szmulewitz R, Petrylak D, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore N, Rosbrook B, Sugg J, Baron B, Chen L, Stenzl A. Phase III study of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): The ARCHES trial. Journal Of Clinical Oncology 2019, 37: 687-687. DOI: 10.1200/jco.2019.37.7_suppl.687.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerRadiographic progression-free survivalAndrogen deprivation therapyCastration-resistant prostate cancerAdverse eventsPrior docetaxelSecondary endpointsDisease volumeOverall survivalProstate cancerNonmetastatic castration-resistant prostate cancerHormone-sensitive prostate cancerProstate-specific antigen progressionEfficacy of enzalutamideHigh-volume diseasePhase 3 studyProgression-free survivalAndrogen receptor inhibitorUnexpected adverse eventsSimilar significant improvementsDeprivation therapyEfficacy endpointPrimary endpointTreatment discontinuationBaseline characteristics
2014
A phase II trial of prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) in taxane-refractory metastatic castration-resistant prostate cancer (mCRPC).
Petrylak D, Smith D, Appleman L, Fleming M, Hussain A, Dreicer R, Sartor A, Shore N, Vogelzang N, Youssoufian H, Olson W, Stambler N, Huang K, Israel R. A phase II trial of prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) in taxane-refractory metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2014, 32: 83-83. DOI: 10.1200/jco.2014.32.4_suppl.83.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerProstate-specific membrane antigenProgressive metastatic castration-resistant prostate cancerProstate-specific antigenCastration-resistant prostate cancerMonomethyl auristatin EPhase II trialAdverse eventsII trialTumor responseProstate cancerECOG PS 0Significant adverse eventsAntibody drugsFree MMAEHigh PSMA expressionAnti-tumor activityProstate cancer cellsCTC declinePrior docetaxelPSA declinePS 0Peripheral neuropathyPSA reductionAntibody therapy
2013
Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane.
Petrylak D, Kantoff P, Mega A, Vogelzang N, Stephenson J, Fleming M, Stambler N, Petrini M, Blattman S, Israel R. Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane. Journal Of Clinical Oncology 2013, 31: 5018-5018. DOI: 10.1200/jco.2013.31.15_suppl.5018.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerProstate-specific membrane antigenProgressive metastatic castration-resistant prostate cancerMonomethyl auristatin ELiver function testsFree MMAEPhase 1 dose-escalation studyCastration-resistant prostate cancerTaxane-containing chemotherapyAntitumor activityDose-escalation studyPhase 2 trialPhase I trialCancer cellsProstate cancer cellsSpecific membrane antigenECOG statusLFT abnormalitiesPrior docetaxelAdverse eventsEscalation studyI trialPeripheral neuropathyAntibody therapyFunction testsProstate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane.
Petrylak D, Kantoff P, Mega A, Vogelzang N, Stephenson J, Fleming M, Stambler N, Petrini M, Huang K, Israel R. Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane. Journal Of Clinical Oncology 2013, 31: 119-119. DOI: 10.1200/jco.2013.31.6_suppl.119.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerProstate-specific membrane antigenMonomethyl auristatin EFree MMAEProstate cancer cellsProgressive metastatic castration-resistant prostate cancerDose levelsPhase 1 dose-escalation studyLiver function test elevationsCastration-resistant prostate cancerTaxane-containing chemotherapyAntitumor activityDose-escalation studyPhase 2 trialPhase I trialCancer cellsClinical disease progressionHighest dose levelSpecific membrane antigenECOG statusLFT abnormalitiesPrior docetaxelAdverse eventsEscalation studyI trial
2008
SATRAPLATIN (S) INCREASES PROGRESSION-FREE SURVIVAL (PFS) AND DELAYS PAIN PROGRESSION IN PATIENTS (PTS) WITH HORMONE REFRACTORY PROSTATE CANCER (HRPC) THAT HAVE PROGRESSED AFTER PRIOR DOCETAXEL
Sternberg N, Sartor O, Petrylak D, Witjes F, Bodrogi I, Harper P, James N, Demkov T, Eymard J, Wirth M. SATRAPLATIN (S) INCREASES PROGRESSION-FREE SURVIVAL (PFS) AND DELAYS PAIN PROGRESSION IN PATIENTS (PTS) WITH HORMONE REFRACTORY PROSTATE CANCER (HRPC) THAT HAVE PROGRESSED AFTER PRIOR DOCETAXEL. European Urology Open Science 2008, 7: 230. DOI: 10.1016/s1569-9056(08)60635-1.Peer-Reviewed Original Research
2007
Satraplatin (S) demonstrates significant clinical benefits for the treatment of patients with HRPC: Results of a randomized phase III trial
Sternberg C, Petrylak D, Witjes F, Ferrero J, Eymard J, Falcon S, Chatta K, Vaughn D, Berry W, Sartor O. Satraplatin (S) demonstrates significant clinical benefits for the treatment of patients with HRPC: Results of a randomized phase III trial. Journal Of Clinical Oncology 2007, 25: 5019-5019. DOI: 10.1200/jco.2007.25.18_suppl.5019.Peer-Reviewed Original ResearchProgression-free survivalIndependent review committeePain progressionPrior docetaxelPrior chemotherapyRadiologic progressionPain responseSide effectsNon-hematologic side effectsRandomized phase III trialGrade 4 neutropeniaGrade 4 thrombocytopeniaObjective tumor responseDouble-blind studyFrequent side effectsPhase III trialsTreatment of patientsSignificant clinical benefitHRPC patientsSPARC trialTreat basisIII trialsPlacebo armPrimary endpointPSA response