Phase Ii Randomized Study Of Abiraterone Acetate Plus Adt Versus Apalutamide Versus Abiraterone And Apalutamide In Patients With Advanced Prostate Cancer With Non-Castrate Testosterone Levels. (Lacog 0415).

TPS404Background: Androgen deprivation therapy (ADT) combined with abiraterone (AA) or docetaxel are considered the standard of care (SOC) for patients with hormone sensitive (HS) advanced/ metastatic prostate cancer (PC) (STAMPEDE, LATITUDE, CHAARTED). Treatment that could delay disease progression with less toxicities and better quality of life is warrant. Recently, enzalutamide monotherapy showed a 92% PSA response in patients with advanced/ mestatatic prostate cancer without previous hormone therapy. Our study aims to evaluate the efficacy of apalutamide, a second-generation AR inhibitor, monotherapy or in combination with AA vs. SOC in advanced/metastatic HSPC. Methods: This is a phase II, open label, randomized trial evaluating the efficacy of AA 1000mg po qd plus prednisone 5mg po bid and ADT vs. Apalutamide 240mg po alone vs. AA and Apalutamide in patients with advanced or metastatic PC with non-castrate testosterone levels. Main eligible criteria are: 1. Histologically confirmed prostate adenocar...