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
2020
National trends in the management of patients with positive surgical margins at radical prostatectomy
Ghabili K, Park HS, Yu JB, Sprenkle PC, Kim SP, Nguyen KA, Ma X, Gross CP, Leapman MS. National trends in the management of patients with positive surgical margins at radical prostatectomy. World Journal Of Urology 2020, 39: 1141-1151. PMID: 32562045, DOI: 10.1007/s00345-020-03298-6.Peer-Reviewed Original ResearchConceptsAndrogen deprivation therapyPositive surgical marginsUse of ADTPost-prostatectomy radiation therapyRadiation therapySurgical marginsRadical prostatectomyInitial courseNode-negative prostate cancerPost-operative radiation therapyMultivariable logistic regression modelNational Cancer DatabaseAdverse pathologic featuresManagement of patientsPost-operative managementLogistic regression modelsDeprivation therapySurgical cancersPrimary endpointRT useSecondary endpointsPathologic characteristicsPathologic featuresUninsured statusCancer Database