Background: 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 adenocarcinoma; 2. Hormone naïve patients with indication to ADT in the following settings: Advanced loco-regional disease not amenable to curative local therapy (T3/4 or node positive); Biochemical relapse after primary treatment (surgery or radiotherapy) with PSA >= 4 ng/ml and rising with doubling time less than 10 months or PSA >= 20 ng/ml or N+ or M+; 3. Newly diagnosed metastatic disease; 4. Patient is symptomatic or moderately symptomatic; 5. Non-castration level of testosterone >= 230 ng/dL. The primary endpoint is undetectable PSA levels (below 0.2ng/mL) at week 25. The study aims for 65% of undetectable PSA at week 25 (power of 80% and alfa of 5%) and a total sample size of 126 patients. Secondary endpoints are PSA progression and PSA response (50% and 80%) at week 25, radiographic progression-free survival, safety, health quality of life (FACT-P) and correlation of serum androgen levels with response. As of October 17th, 2017 the study enrolled 1 patient and the recruitment is planned for 12 months in a total of 10 sites in Brazil. This trial is registered at Clinical trial information: NCT02867020