LAUSR

147Background: ENZ is an androgen receptor inhibitor that improved survival in studies of men with mCRPC. Seizure is a risk of ENZ treatment, and patients (pts) with seizure risk factors were excluded in prior studies. In the TRUVEN report (data on file), pts with mCRPC and potential seizure risk factors, but no ENZ exposure, had a seizure rate of 2.8/100 pt-years. The UPWARD study assessed the seizure risk in ENZ-treated pts with mCRPC who had potential seizure risk factors. Methods: This was a global, multicenter, single-arm, open-label safety study. Enrolled pts had ≥ 1 baseline potential seizure risk factor, including medications lowering seizure threshold, stroke, or prior seizure history. Evaluable pts had ≥ 3 months (ms) of treatment with ENZ or ≥ 1 confirmed seizure in a 4-m treatment period. Exclusion criteria included seizure within the past 12 ms and receipt of anti-epileptic medication. Pts received ENZ (160 mg/day). The primary end point was the proportion of evaluable pts with ≥ 1 confirmed ...