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 events