Type of Study: Clinical Trial

Sponsor / Support: LACOG, BAYER

Primary Objectives: The primary objective of the study is to determine the anti-tumor activity of the combination of BAT (bipolar androgen therapy) plus Darolutamide (DARO) in patients with metastatic castration-resistant prostate cancer (mCRPC), measured by radiographic progression free-survival (rPFS).

Design: This is a Phase II, single-arm, multi-center, open-label trial

Sample Size: 47 patients

Principal Investigator: Diogo Assed Bastos and Pedro Isaacsson Velho

Countries LATAM: Brazil

Clinicaltrials.gov Identifier: NCT04558866