TRANSFORMER: A Randomized Phase II Study Comparing Bipolar Androgen Therapy Versus Enzalutamide in Asymptomatic Men With Castration-Resistant Metastatic Prostate Cancer.
Samuel R DenmeadeHao WangArchana M AgarwalDavid C SmithMichael Thomas SchweizerMark N SteinVasileios AssikisPrzemyslaw W TwardowskiThomas W FlaigRussell Z SzmulewitzJeffrey M HolzbeierleinRalph J HaukeGuru P SonpavdeJorge A GarciaArif HussainA Oliver SartorShifeng S MaoHarry CaoWei FuTing WangRehab AbdallahSu Jin LimVanessa CilentoChanning J PallerMichael A CarducciMark C MarkowskiMario A EisenbergerEmmanuel S AntonarakisPublished in: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (2021)
This randomized trial establishes meaningful clinical activity and safety of BAT and supports additional study to determine its optimal clinical integration. BAT can sensitize CRPC to subsequent antiandrogen therapy. Further study is required to confirm whether sequential therapy with BAT and enzalutamide can improve survival in men with CRPC.