2024
Testosterone Recovery and Associated Impact on Patient-Reported Health-Related Quality of Life (HRQoL) after Treatment with 6 Months of GnRH Agonist with or without Abiraterone Acetate plus Prednisone (AAP) and Apalutamide (Apa) in the FORMULA-509 Trial
Moningi S, Nguyen P, Rathkopf D, Zurita-Saavedra A, Spratt D, Dess R, Liauw S, Szmulewitz R, Einstein D, Bubley G, Yu J, An Y, Wong A, Feng F, Mckay R, Rose B, Shin K, Taplin M, Kollmeier M, Hoffman K. Testosterone Recovery and Associated Impact on Patient-Reported Health-Related Quality of Life (HRQoL) after Treatment with 6 Months of GnRH Agonist with or without Abiraterone Acetate plus Prednisone (AAP) and Apalutamide (Apa) in the FORMULA-509 Trial. International Journal Of Radiation Oncology • Biology • Physics 2024, 120: e563-e564. DOI: 10.1016/j.ijrobp.2024.07.1247.Peer-Reviewed Original ResearchMonths of GnRH agonistTestosterone recoveryGnRH agonistAssociated with lackClinically meaningful changeBaseline testosteroneAssociated with testosterone recoveryMedian follow-upEvaluated prior to treatmentTreatment groupsTrial randomized patientsHormonal functionPatient-reported health-related quality of lifeLog-rank testCompletion of treatmentMultivariate logistic regressionWilcoxon rank-sumPatient-reported HRQoL.Salvage radiationGleason scoreAbiraterone acetateHigher PSARecovery 1 yearRandomized patientsHealth-related quality of lifeLong-Term Patient-Reported Health-Related Quality of Life in the Randomized FORMULA-509 Trial of Salvage Radiotherapy and 6 Months of GnRH Agonist with Either Bicalutamide or Abiraterone Acetate Plus Prednisone and Apalutamide after Radical Prostatectomy
Hoffman K, Nguyen P, Rathkopf D, Zurita-Saavedra A, Spratt D, Dess R, Liauw S, Szmulewitz R, Einstein D, Bubley G, Yu J, An Y, Wong A, Feng F, Mckay R, Rose B, Lee K, Kibel A, Taplin M, Kollmeier M. Long-Term Patient-Reported Health-Related Quality of Life in the Randomized FORMULA-509 Trial of Salvage Radiotherapy and 6 Months of GnRH Agonist with Either Bicalutamide or Abiraterone Acetate Plus Prednisone and Apalutamide after Radical Prostatectomy. International Journal Of Radiation Oncology • Biology • Physics 2024, 120: s54. DOI: 10.1016/j.ijrobp.2024.07.088.Peer-Reviewed Original ResearchAbiraterone acetate plus prednisoneMonths of GnRH agonistAcetate plus prednisonePatient-reported health-related quality of lifeEPIC-26Hormonal functionHealth-related quality of lifeGnRH agonistTreatment armsTreatment to 1 yearQuality of lifeMental statusMetastasis-free survivalBaseline to endCompletion of treatmentSalvage radiationSalvage radiotherapyOncological outcomesRadical prostatectomyClinically meaningful differencesSaint Louis University Mental Status ExamNear baselineClinically meaningful declineT-scoreHormonal domainsPatient-reported health-related quality of life (HRQoL) in the randomized FORMULA-509 trial of salvage radiotherapy and 6 months of GnRH agonist with either bicalutamide or abiraterone acetate plus prednisone (AAP) and apalutamide (Apa) after radical prostatectomy (RP).
Hoffman K, Nguyen P, Rathkopf D, Zurita A, Spratt D, Dess R, Liauw S, Szmulewitz R, Einstein D, Bubley G, Yu J, An Y, Wong A, Feng F, McKay R, Rose B, Shin K, Kibel A, Taplin M, Kollmeier M. Patient-reported health-related quality of life (HRQoL) in the randomized FORMULA-509 trial of salvage radiotherapy and 6 months of GnRH agonist with either bicalutamide or abiraterone acetate plus prednisone (AAP) and apalutamide (Apa) after radical prostatectomy (RP). Journal Of Clinical Oncology 2024, 42: 260-260. DOI: 10.1200/jco.2024.42.4_suppl.260.Peer-Reviewed Original ResearchAbiraterone acetate plus prednisoneSaint Louis University Mental Status ExamMonths of GnRH agonistPatient-reported health-related quality of lifeEPIC-26Radical prostatectomyHealth-related quality of lifeGnRH agonistTreatment armsHormonal functionPROMIS FatigueTreatment to 1 yearQuality of lifeAcetate plus prednisoneMental statusMetastasis-free survivalBaseline to endMental status examStandardized T scoresMild neurocognitive disorderCompletion of treatmentSalvage radiationSalvage radiotherapyOncological outcomesClinically meaningful differences
2023
FORMULA-509: A Multicenter Randomized Trial of Post-Operative Salvage Radiotherapy (SRT) and 6 Months of GnRH Agonist with Either Bicalutamide or Abiraterone Acetate/Prednisone (AAP) and Apalutamide (Apa) Post-Radical Prostatectomy (RP)
Nguyen P, Kollmeier M, Rathkopf D, Hoffman K, Zurita-Saavedra A, Spratt D, Dess R, Liauw S, Szmulewitz R, Einstein D, Bubley G, Yu J, An Y, Wong A, Feng F, Mckay R, Rose B, Shin K, Kibel A, Taplin M. FORMULA-509: A Multicenter Randomized Trial of Post-Operative Salvage Radiotherapy (SRT) and 6 Months of GnRH Agonist with Either Bicalutamide or Abiraterone Acetate/Prednisone (AAP) and Apalutamide (Apa) Post-Radical Prostatectomy (RP). International Journal Of Radiation Oncology • Biology • Physics 2023, 117: s81-s82. DOI: 10.1016/j.ijrobp.2023.06.401.Peer-Reviewed Original ResearchPSA progression-free survivalMetastasis-free survivalMonths of GnRH agonistAbiraterone acetate/prednisoneSalvage radiotherapyGnRH agonistPre-planned analysisPost-RPStratification factorsProgression-free survivalPost-radical prostatectomyMedian follow-upSubgroup of patientsMulticenter randomized trialOne-sided type I errorPre-planned subgroup analysisStatistically significant benefitTwo-sided p-valuePelvic nodesOpen-labelPrimary endpointSecondary endpointsInvestigator-initiatedSafety profileAdverse eventsFORMULA-509: A multicenter randomized trial of post-operative salvage radiotherapy (SRT) and 6 months of GnRH agonist with or without abiraterone acetate/prednisone (AAP) and apalutamide (Apa) post-radical prostatectomy (RP).
Nguyen P, Kollmeier M, Rathkopf D, Hoffman K, Zurita A, Spratt D, Dess R, Liauw S, Szmulewitz R, Einstein D, Bubley G, Yu J, An Y, Wong A, Feng F, McKay R, Rose B, Shin K, Kibel A, Taplin M. FORMULA-509: A multicenter randomized trial of post-operative salvage radiotherapy (SRT) and 6 months of GnRH agonist with or without abiraterone acetate/prednisone (AAP) and apalutamide (Apa) post-radical prostatectomy (RP). Journal Of Clinical Oncology 2023, 41: 303-303. DOI: 10.1200/jco.2023.41.6_suppl.303.Peer-Reviewed Original ResearchPSA progression-free survivalMetastasis-free survivalMonths of GnRH agonistAbiraterone acetate/prednisoneSalvage radiotherapyPre-planned analysisGnRH agonistPost-RPStratification factorsProgression-free survivalPost-radical prostatectomyMedian follow-upMonths of ADTSubgroup of patientsMulticenter randomized trialOne-sided type I errorPre-planned subgroup analysisStatistically significant benefitPelvic nodesOpen-labelPrimary endpointSecondary endpointsInvestigator-initiatedSafety profileAdverse events