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).
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