2024
Final study analysis of PRINT: Prostate cancer intensive, non–cross-reactive therapy for CRPC.
Liaw B, Joshi H, Sheng T, Tsao C, Galsky M, Bakst R, Stewart R, Stock R, Oh W. Final study analysis of PRINT: Prostate cancer intensive, non–cross-reactive therapy for CRPC. Journal Of Clinical Oncology 2024, 42: 147-147. DOI: 10.1200/jco.2024.42.4_suppl.147.Peer-Reviewed Original ResearchPSA response rateAlkaline phosphatase levelsStudy regimenImproved time to disease progressionPhosphatase levelsTime to disease progressionStandard managementResponse rateTreatment of mCRPCBaseline alkaline phosphatase levelsProlonged disease controlMinimize treatment toxicitySignificant antitumor responsesPrevent drug resistanceLong-term suppressionMedian TTPAntitumor responseMedian followTreatment toxicityPrimary endpointProstate cancerSecondary endpointsMCRPCTreatment regimenHeterogeneous disease
2023
Real world utilization and outcomes of immunotherapy regimens in metastatic castration resistant prostate cancer (mCRPC).
Ganta T, Anker J, Miller E, Tsao K, Oh W. Real world utilization and outcomes of immunotherapy regimens in metastatic castration resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2023, 41: e17038-e17038. DOI: 10.1200/jco.2023.41.16_suppl.e17038.Peer-Reviewed Original ResearchMetastatic castration resistant prostate cancerImmune checkpoint inhibitorsOverall survivalResponse rateCastration resistant prostate cancerSingle-center retrospective studyPSA response rateMedian overall survivalResistant prostate cancerOvercome treatment resistanceNon-metastatic diseaseKaplan-Meier curvesOff-label prescribingCheckpoint inhibitorsCancer regimensImmunotherapy regimensMedian durationProstate cancerCombinatorial regimensTreatment resistanceRetrospective studyTreatment paradigmChart reviewHistorical cohortTreatment options
2021
Safety and Clinical Activity of Atezolizumab in Patients with Metastatic Castration-Resistant Prostate Cancer: A Phase I StudyAtezolizumab in Castration-Resistant Prostate Cancer
Petrylak DP, Loriot Y, Shaffer DR, Braiteh F, Powderly J, Harshman LC, Conkling P, Delord JP, Gordon M, Kim JW, Sarkar I, Yuen K, Kadel EE, Mariathasan S, O'Hear C, Narayanan S, Fassò M, Carroll S, Powles T. Safety and Clinical Activity of Atezolizumab in Patients with Metastatic Castration-Resistant Prostate Cancer: A Phase I StudyAtezolizumab in Castration-Resistant Prostate Cancer. Clinical Cancer Research 2021, 27: 3360-3369. PMID: 33568344, DOI: 10.1158/1078-0432.ccr-20-1981.Peer-Reviewed Original ResearchConceptsMetastatic castration-resistant prostate cancerCastration-resistant prostate cancerPartial responseProstate cancerAtezolizumab monotherapyOverall survivalPrior linesImmune-related response criteriaTreatment-related adverse eventsDose-expansion studyPSA response rateMedian overall survivalBiomarker analysisEvaluable patientsRECIST 1.1Adverse eventsOS ratesClinical benefitSafety profileDisease progressionAtezolizumabClinical activityRadiographic assessmentImmune responseLimited efficacy
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 pointPRINT: Prostate cancer intensive, non-cross reactive therapy for CRPC—Early observations of efficacy.
Liaw B, Tsao C, Galsky M, Bakst R, Stewart R, Stock R, Oh W. PRINT: Prostate cancer intensive, non-cross reactive therapy for CRPC—Early observations of efficacy. Journal Of Clinical Oncology 2020, 38: e17575-e17575. DOI: 10.1200/jco.2020.38.15_suppl.e17575.Peer-Reviewed Original ResearchTime to progressionMedian time to PSA progressionSequencing of therapeutic agentsTime to PSA progressionTime-to-progression analysisPSA response rateTreatment of mCRPCMinimize treatment toxicityPrevent drug resistanceLong-term suppressionObservations of efficacyPSA progressionMedian followRestarting therapyAntitumor benefitRadium-223Study regimenTreatment toxicityStudy regimensPrimary endpointProstate cancerMCRPCTherapy completionDrug resistanceRegimenSafety 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 0PRINT: Prostate cancer intensive, non-cross reactive therapy for CRP—Early observations of efficacy.
Liaw B, Tsao C, Galsky M, Bakst R, Stewart R, Stock R, Oh W. PRINT: Prostate cancer intensive, non-cross reactive therapy for CRP—Early observations of efficacy. Journal Of Clinical Oncology 2020, 38: 89-89. DOI: 10.1200/jco.2020.38.6_suppl.89.Peer-Reviewed Original ResearchTime to progressionMedian time to PSA progressionSequencing of therapeutic agentsTime to PSA progressionTime-to-progression analysisPSA response rateTreatment of mCRPCLong-term suppressionObservations of efficacyPSA progressionMedian followRestarting therapyAntitumor benefitRadium-223Study regimenStudy regimensPrimary endpointProstate cancerMCRPCTherapy completionDrug resistanceRegimenDrug selectionDelay progressionPatients
2019
PRINT: Prostate cancer intensive, non-cross reactive therapy for CRPC—Early observations of feasibility and efficacy.
Liaw B, Tsao C, Galsky M, Bakst R, Stewart R, Stock R, Oh W. PRINT: Prostate cancer intensive, non-cross reactive therapy for CRPC—Early observations of feasibility and efficacy. Journal Of Clinical Oncology 2019, 37: 310-310. DOI: 10.1200/jco.2019.37.7_suppl.310.Peer-Reviewed Original ResearchPrimary endpointMedian time to PSA progressionTime to PSA progressionTime to disease progressionPSA response rateTreatment of mCRPCMinimize treatment toxicityPrevent drug resistancePSA progressionMedian followAntitumor benefitMonthly regimenRadium-223Bone metastasesTreatment toxicityStudy regimensProstate cancerMCRPCHeterogeneous diseaseDrug resistanceDisease progressionWeeks durationDelay progressionResponse ratePatients
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
2008
What is the current status of second-line chemotherapy for castration-resistant prostate cancer?
Rosenberg J, Oh W. What is the current status of second-line chemotherapy for castration-resistant prostate cancer? Nature Reviews Urology 2008, 5: 650-651. PMID: 18936787, DOI: 10.1038/ncpuro1232.Peer-Reviewed Original ResearchCastration-resistant prostate cancerMedian time to PSA progressionTime to PSA progressionPSA response ratePSA progressionProstate cancerCastration-resistant prostate cancer treated with docetaxelMedian survival of patientsResponse rateFirst-line docetaxelSecond-line chemotherapyFirst-line chemotherapyFirst-line agentsSurvival of patientsProgression of diseaseMitoxantrone therapyMedian survivalTreatment optionsRetrospective analysisDocetaxelClinical trialsPatient populationCytotoxic agentsMitoxantronePatients
2006
Response to low‐dose ketoconazole and subsequent dose escalation to high‐dose ketoconazole in patients with androgen‐independent prostate cancer
Nakabayashi M, Xie W, Regan M, Jackman D, Kantoff P, Oh W. Response to low‐dose ketoconazole and subsequent dose escalation to high‐dose ketoconazole in patients with androgen‐independent prostate cancer. Cancer 2006, 107: 975-981. PMID: 16862573, DOI: 10.1002/cncr.22085.Peer-Reviewed Original ResearchConceptsAndrogen-independent prostate cancerHigh-dose ketoconazoleLow-dose ketoconazoleSecondary hormonal therapyProstate-specific antigenDose escalationHormone therapyProstate cancerMedian time to disease progressionProstate-specific antigen declines >PSA response ratePrimary androgen deprivation therapyTime to disease progressionAndrogen deprivation therapySevere adverse eventsReversible adverse effectsConcomitant steroidsDeprivation therapyAdverse eventsDisease progressionTherapyGrade 1PatientsResponse rateDoseIntermittent 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 valuesPhase II study of low dose (LD) and high dose (HD) premarin in androgen independent prostate cancer (AIPC)
Pomerantz M, Manola J, Taplin M, Bubley G, Inman M, Lowell J, Kantoff P, Oh W. Phase II study of low dose (LD) and high dose (HD) premarin in androgen independent prostate cancer (AIPC). Journal Of Clinical Oncology 2006, 24: 4560-4560. DOI: 10.1200/jco.2006.24.18_suppl.4560.Peer-Reviewed Original ResearchAndrogen-independent prostate cancerLow dosesHigh dosesLD armProgressive androgen-independent prostate cancerHD armMedian time to progressionClinical predictors of responseStudy of low doseGrade 3 toxicityPatients treated with LDProphylactic breast irradiationPSA response rateTime to progressionIndependent prostate cancerPhase II studyStage of accrualPredictors of responseCorrelates of treatment responseWarfarin 1 mgDose of PremarinBreast irradiationProphylactic warfarinTransdermal estradiolMedian PSAUtility of prostate specific antigen doubling time (PSA-DT) at the start of androgen independent prostate cancer (AIPC) and immediately before chemotherapy in predicting efficacy of taxane chemotherapy
Regan M, Daskivich T, Kantoff P, Oh W. Utility of prostate specific antigen doubling time (PSA-DT) at the start of androgen independent prostate cancer (AIPC) and immediately before chemotherapy in predicting efficacy of taxane chemotherapy. Journal Of Clinical Oncology 2006, 24: 4640-4640. DOI: 10.1200/jco.2006.24.18_suppl.4640.Peer-Reviewed Original ResearchAndrogen-independent prostate cancerPSA response rateEfficacy of taxane chemotherapyAndrogen deprivation therapyPSA-DTTaxane chemotherapyAndrogen independenceProstate cancerResponse rateProstate specific antigen doubling timeMetastatic androgen-independent prostate cancerShort PSA DTIndependent prostate cancerResponse to chemotherapyStandard of carePSA nadirDeprivation therapyPSA valuesPre-chemotherapyProspective studyChemotherapyNext treatmentPrimary outcomeAndrogenPSAResponse to low-dose ketoconazole and subsequent dose escalation to high-dose ketoconazole in patients with androgen-independent prostate cancer
Nakabayashi M, Xie W, Regan M, Jackman D, Kantoff P, Oh W. Response to low-dose ketoconazole and subsequent dose escalation to high-dose ketoconazole in patients with androgen-independent prostate cancer. Journal Of Clinical Oncology 2006, 24: 4646-4646. DOI: 10.1200/jco.2006.24.18_suppl.4646.Peer-Reviewed Original ResearchAndrogen-independent prostate cancerHigh dose ketoconazoleLow dose ketoconazoleProstate-specific antigenSecondary hormonal therapyDose escalationHormone therapyProstate cancerPSA response rateMedian prostate-specific antigenDose-escalation groupHigh-dose ketoconazoleLow-dose ketoconazoleIndependent prostate cancerSevere adverse eventsDevelopment of toxicityReversible adverse effectsConcomitant steroidsMedian durationMedian ageEscalation groupAdverse eventsNon-respondersTherapyPatients
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
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