NCT07339267

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

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics and Safety of ASP5541 in Chinese Participants With Advanced Prostate Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Metastatic Castration-Resistant Prostate Cancer
• Metastatic Hormone Sensitive Prostate Cancer

Interventions

Type	Name	Description
DRUG	ASP5541	Intramuscular injection
DRUG	Prednisone	Oral

Timeline

• Start date: 2026-01-20
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-01-14
• Last updated: 2026-02-18

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study