A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer
Trial Parameters
Brief Summary
In this study, ASP5541 will be given to Chinese men with prostate cancer. It will be given together with prednisone and androgen deprivation therapy (ADT). Prednisone is a steroid, and ADT is already given to the men as their standard of care for prostate cancer. The main aims of the study are to check the safety of ASP5541, when given with prednisone and ADT, and to check how ASP5541 moves through the bodies of Chinese men. The men will receive ASP5541 as an injection into a muscle (intramuscular injection) at the side of the hip. They will all receive the same dose of ASP5541. The men will be given prednisone and ADT according to their label. The men will continue to receive ASP5541 with prednisone and ADT until their cancer gets worse or the doctor decides the men should stop study treatment.
Eligibility Criteria
Inclusion Criteria: * Participant is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features. * Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or ECOG performance status of 2 if due to bone pain. * Participant must have an estimated life expectancy of ≥ 12 months with metastatic hormone-sensitive prostate cancer (mHSPC) or ≥ 6 months with metastatic castration-resistant prostate cancer (mCRPC). * Participant is able to understand and comply with all study requirements and procedures. * Participant has been diagnosed with mCRPC or mHSPC documented by metastatic lesions on a bone scan, computed tomography (CT), magnetic resonance imaging (MRI) or prostate-specific membrane antigen positron emission tomography (PSMA-PET). * Participant is receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or has a his