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 pointSafety and clinical activity of atezolizumab (atezo) + radium-223 dichloride (r-223) in 2L metastatic castration-resistant prostate cancer (mCRPC): Results from a phase Ib clinical trial.
Morris M, Fong L, Petrylak D, Sartor A, Higano C, Pagliaro L, Alva A, Appleman L, Tan W, Vaishampayan U, Porcu R, Tayama D, Kadel E, Yuen K, Datye A, Armstrong A. Safety and clinical activity of atezolizumab (atezo) + radium-223 dichloride (r-223) in 2L metastatic castration-resistant prostate cancer (mCRPC): Results from a phase Ib clinical trial. Journal Of Clinical Oncology 2020, 38: 5565-5565. DOI: 10.1200/jco.2020.38.15_suppl.5565.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPSA response ratePSA progressionDosing schedulesPD-L1Clinical benefitResponse ratePD-1/PD-L1Castration-resistant prostate cancerPhase Ib clinical trialPhase 1b studyPhase Ib studyTumor-directed radiationAnti-tumor immunityDose-limiting toxicityRadium-223 dichlorideLimited treatment optionsMechanism of actionEvaluable ptsRadiographic PFSMCRPC patientsMedian OSBaseline characteristicsEvaluable dataUnacceptable toxicityPhase 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
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
2013
Double-blind randomized trial of aflibercept versus placebo with docetaxel and prednisone for treatment of metastatic castration-resistant prostate cancer (mCRPC).
Tannock I, Fizazi K, Ivanov S, Thellenberg-Karlsson C, Flechon A, Skoneczna I, Orlandi F, Gravis G, Matveev V, Bavbek S, Gil T, Viana L, Aren O, Karyakin O, Elliott T, Birtle A, Magherini E, Petrylak D, Tombal B, Rosenthal M. Double-blind randomized trial of aflibercept versus placebo with docetaxel and prednisone for treatment of metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2013, 31: 5002-5002. DOI: 10.1200/jco.2013.31.15_suppl.5002.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerDocetaxel/prednisoneFirst-line chemotherapyAflibercept armPlacebo armHazard ratioMedian relative dose intensityRecombinant human fusion proteinStandard first-line chemotherapyCastration-resistant prostate cancerGrowth factorAdequate organ functionCycles of therapyPSA response rateRelative dose intensityFatal adverse eventsProgression-free survivalVascular endothelial growth factorClinical trial informationEndothelial growth factorHuman fusion proteinTrial-specific modulesOral prednisonePrimary endpointPrior chemotherapy
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 cutoff
2006
Intermittent chemotherapy in metastatic androgen-independent prostate cancer (AIPC): Initial results from ASCENT
Beer T, Ryan C, Venner P, Petrylak D, Chatta G, Ruether J, Chi K, Arroyo A, Clow F. Intermittent chemotherapy in metastatic androgen-independent prostate cancer (AIPC): Initial results from ASCENT. Journal Of Clinical Oncology 2006, 24: 4518-4518. DOI: 10.1200/jco.2006.24.18_suppl.4518.Peer-Reviewed Original ResearchAndrogen-independent prostate cancerMetastatic androgen-independent prostate cancerMulti-institutional trialSerum PSAIntermittent chemotherapyChemotherapy holidayTreatment holidayDN-101Large multi-institutional trialsOverall PSA response rateDocetaxel-containing chemotherapyFirst large trialPSA response rateResumption of treatmentPhase III studyMinority of patientsPhase II dataStable PSASame regimenIII studyMedian durationMost patientsSurvival benefitLarge trialsPSA values
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
1999
Phase I trial of docetaxel with estramustine in androgen-independent prostate cancer.
Petrylak D, Macarthur R, O'Connor J, Shelton G, Judge T, Balog J, Pfaff C, Bagiella E, Heitjan D, Fine R, Zuech N, Sawczuk I, Benson M, Olsson C. Phase I trial of docetaxel with estramustine in androgen-independent prostate cancer. Journal Of Clinical Oncology 1999, 17: 958-67. PMID: 10071290, DOI: 10.1200/jco.1999.17.3.958.Peer-Reviewed Original ResearchConceptsAndrogen-independent prostate cancerEPT patientsProstate cancerMPT patientsProgressive metastatic androgen-independent prostate cancerMetastatic androgen-independent prostate cancerDose-limiting myelosuppressionGrade 3/4 granulocytopeniaPSA response ratePhase II doseDoses of docetaxelPhase I trialPharmacokinetics of docetaxelBone painMeasurable diseaseOral estramustinePo tidPain medicationPartial responseSerum PSAI trialNarcotic analgesicsTime of entryPatientsDay 1