This is a Phase 3 randomized, open-label study to evaluate the pharmacodynamic effect and safety profile of TAVT-45 compared to Zytiga (reference abiraterone acetate formulation, hereafter referred to as R-AA) in patients with mCSPC and mCRPC. Randomization will be stratified by prostate cancer population (CSPC vs CRPC) and baseline testosterone (<10 vs ≥ 10 ng/dL). Patients will be treated for 84 days and randomized into one of two groups in a 1:1 ratio:~TAVT-45: Administered twice daily as 1 x sachet containing TAVT-45 (250 mg abiraterone acetate) + Prednisone (5 mg once or twice daily, depending on prostate cancer population)~R-AA: Administered once daily as (2 x 500 mg Zytiga tablets) + Prednisone (5 mg once or twice daily, depending on prostate cancer population)
The purpose of this study is to investigate the safety and efficacy of a new formulation of an existing drug product called TAVT-45 in patients with metastatic prostate cancer.