A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer

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

Trial Details

NCT ID
NCT07339267
Phase
PHASE1
Sponsor
Astellas Pharma Global Development, Inc.
Status
RECRUITING
Cancer Type
Hormone-Sensitive Prostate Cancer
Interventions
  • ASP5541
  • Prednisone
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • Participant is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or sm…
  • 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 meta…
  • Participant is able to understand and comply with all study requirements and procedures.

For full eligibility, visit ClinicalTrials.gov.

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