2019
PSA decline and objective response rates in White (W), Black (B), and Asian men with metastatic castration-resistant prostate cancer (mCRPC).
Halabi S, Dutta S, Chi K, Tangen C, Xuan M, Petrylak D, Araujo J, Fizazi K, Quinn D, Morris M, Higano C, Tannock I, Small E, Kelly W. PSA decline and objective response rates in White (W), Black (B), and Asian men with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2019, 37: 5021-5021. DOI: 10.1200/jco.2019.37.15_suppl.5021.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerObjective response rateCastration-resistant prostate cancerPSA declinePercentage of patientsPooled odds ratioMultivariable analysisAsian menAA menOdds ratioProstate cancerResponse ratePhase III clinical trialsPhase III trialsResistant prostate cancerSite of metastasisIndividual patient dataLogistic regression modelsMeasurable diseaseIII trialsPerformance statusTreatment armsPrognostic importanceC menRisk factors
2015
A phase 2 study of prostate specific membrane antigen antibody drug conjugate (PSMA ADC) in patients (pts) with progressive metastatic castration-resistant prostate cancer (mCRPC) following abiraterone and/or enzalutamide (abi/enz).
Petrylak D, Vogelzang N, Chatta G, Fleming M, Smith D, Appleman L, Hussain A, Modiano M, Singh P, Tagawa S, Gore I, McClay E, Mega A, Sartor A, Somer B, Wadlow R, Shore N, Stambler N, DiPippo V, Israel R. A phase 2 study of prostate specific membrane antigen antibody drug conjugate (PSMA ADC) in patients (pts) with progressive metastatic castration-resistant prostate cancer (mCRPC) following abiraterone and/or enzalutamide (abi/enz). Journal Of Clinical Oncology 2015, 33: 144-144. DOI: 10.1200/jco.2015.33.7_suppl.144.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerCTC declineProgressive metastatic castration-resistant prostate cancerCastration-resistant prostate cancerAntitumor activityMeasurable target lesionsNeuroendocrine serum markersPhase 2 studyPhase 2 trialPhase 1 studyHigh PSMA expressionProstate cancer cellsPSMA-positive cellsRadiologic responseHuman IgG1 antibodyPSA declineRadiologic evidenceElectrolyte imbalanceSerum markersCTC countEfficacy responseTarget lesionsProstate cancerPSMA expressionEnz treatment
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
A phase I/II study of safety and efficacy of orteronel (TAK-700), an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC): Updated phase II results.
Petrylak D, Gandhi J, Clark W, Heath E, Lin J, Oh W, Agus D, Carthon B, Moran S, Kong N, Suri A, Bargfrede M, Liu G. A phase I/II study of safety and efficacy of orteronel (TAK-700), an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC): Updated phase II results. Journal Of Clinical Oncology 2013, 31: 59-59. DOI: 10.1200/jco.2013.31.6_suppl.59.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPSA responseMedian timePhase I/II studyCastration-resistant prostate cancerDrug-related SAEsECOG PS 0/1Good PSA responseProgression of PsAPhase 1/2 studyPartial tumor responsePhase II resultsBlood alkaline phosphataseCastrate menPS 0/1Median PSAPrior chemotherapyPSA declinePSA progressionRadiologic progressionRECIST 1.1Data cutoffII studyRadiographic diseaseSerum PSA
2012
918P Phase 2 Results from a Phase 1/2 Study of Tak-700 (ORTERONEL), An Oral, Investigational, Nonsteroidal 17,20-Lyase Inhibitor, with Docetaxel and Prednisone (DP) in Metastatic Castration-Resistant Prostate Cancer (MCRPC)
Petrylak D, Gandhi J, Clark W, Heath E, Lin J, Oh W, Agus D, Carthon B, Moran S, Liu G. 918P Phase 2 Results from a Phase 1/2 Study of Tak-700 (ORTERONEL), An Oral, Investigational, Nonsteroidal 17,20-Lyase Inhibitor, with Docetaxel and Prednisone (DP) in Metastatic Castration-Resistant Prostate Cancer (MCRPC). Annals Of Oncology 2012, 23: ix302-ix303. DOI: 10.1016/s0923-7534(20)33476-1.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPhase 1/2 studyTAK-700Febrile neutropeniaMedian timeCastration-resistant prostate cancerDrug-related SAEsECOG PS 0/1Good PSA responseProgression of PsAPSA response rateTreatment-related AEsPartial tumor responseLyase inhibitorMillennium PharmaceuticalsGlaxo Smith KlineCastrate menEvaluable populationPrior chemotherapyPS 0/1PSA declinePSA progressionRadiologic progressionRECIST 1.1Data cutoffPhase I results from a phase I/II study of orteronel, an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC).
Petrylak D, Gandhi J, Clark W, Heath E, Lin J, Oh W, Agus D, Kucuk O, Moran S, Wang J, Bargfrede M, Liu G. Phase I results from a phase I/II study of orteronel, an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2012, 30: 4656-4656. DOI: 10.1200/jco.2012.30.15_suppl.4656.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerSerious AEsFebrile neutropeniaCohort 1Phase I/II studyCastration-resistant prostate cancerCommon serious AEsECOG PS 0/1Median age 68Median PSA declinePhase 1/2 studyPhase II portionLyase inhibitorCastrate menPS 0/1Measurable diseaseMedian PSAPrior chemotherapyPSA declineII studyInfusion reactionsNeutrophil countStandard chemotherapyDose escalationWBC count
2006
Pharmacokinetics (PK), safety and tolerability of atrasentan (ABT-627, ATN) in combination with docetaxel (DOC) in men with hormone refractory prostate cancer (HRPC)
Petrylak D, Mohile S, Shelton G, Carr R, Steinberg J, Sleep D, Melia J, Rieser M, Nanus D, Milowsky M. Pharmacokinetics (PK), safety and tolerability of atrasentan (ABT-627, ATN) in combination with docetaxel (DOC) in men with hormone refractory prostate cancer (HRPC). Journal Of Clinical Oncology 2006, 24: 14512-14512. DOI: 10.1200/jco.2006.24.18_suppl.14512.Peer-Reviewed Original ResearchHormone-refractory prostate cancerPSA declineAdverse eventsTreatment of HRPCPhase III clinical developmentPhase III studyRefractory prostate cancerUnexpected adverse eventsDOC infusionNeutropenic feverIII studyLiver metastasesOral dosesPO QDSelective endothelinPK interactionsReceptor antagonistPlasma concentrationsProstate cancerCYP3A4 activityClinical developmentDay 1DocetaxelPK resultsPharmacokinetics
2000
DEXAMETHASONE DOES NOT SIGNIFICANTLY CONTRIBUTE TO THE RESPONSE RATE OF DOCETAXEL AND ESTRAMUSTINE IN ANDROGEN INDEPENDENT PROSTATE CANCER
WEITZMAN A, SHELTON G, ZUECH N, OWEN C, JUDGE T, BENSON M, SAWCZUK I, KATZ A, OLSSON C, BAGIELLA E, PFAFF C, NEWHOUSE J, PETRYLAK D. DEXAMETHASONE DOES NOT SIGNIFICANTLY CONTRIBUTE TO THE RESPONSE RATE OF DOCETAXEL AND ESTRAMUSTINE IN ANDROGEN INDEPENDENT PROSTATE CANCER. Journal Of Urology 2000, 163: 834-837. PMID: 10687988, DOI: 10.1016/s0022-5347(05)67815-9.Peer-Reviewed Original ResearchConceptsProstate-specific antigenAndrogen-independent prostate cancerIndependent prostate cancerResponse rateMedian timeProstate cancerBaseline prostate-specific antigenSerum prostate-specific antigenMedian PSA increasePSA response rateDexamethasone monotherapyEstramustine administrationPSA declineMedian durationPartial responsePSA increaseDisease 3Day 1Specific antigenWeek 9Day 2EstramustinePatientsDocetaxelDexamethasone