Phase 3 Randomized Study of Talazoparib with Enzalutamide in Men with DDR Gene Mutated mCSPC

You likely can't join if

• 1. Other acute or chronic medical [concurrent disease, infection, including chronic stable Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, or co-morbidity] or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that interferes with a participant’s ability to participate in the study, may increase the risk associated with study participation or study treatment administration, or may interfere with the interpretation of study results, and, in the investigator’s judgment, make the participant inappropriate for entry into the study. HIV/HBV/HCV testing is not required unless mandated by local health authority.
• 2. History of seizure or any condition (as assessed by investigator) that may predispose to seizure
• 3. Known or suspected brain metastasis or active leptomeningeal disease.
• 4. Clinically significant cardiovascular disease.
• 5. Prior treatment in any setting with NHT except prior ADT in the adjuvant/neoadjuvant setting, where the completion of ADT was less than 12 months prior to randomization and the total duration of ADT exceeded 36 months.
• 6. Any previous treatment with DNA-damaging cytotoxic chemotherapy (ie, platinum based therapy) within 5 years prior to randomization, except for indications other than prostate cancer.