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

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT07339267
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • ASP5541 — DRUG
    Intramuscular injection
  • Prednisone — DRUG
    Oral

Study Details

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.

Key Dates

First listed
Jan 14, 2026
Start date
Jan 20, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ASP5541
    Participants will receive ASP5541 once every 12 weeks and prednisone either once daily (mHSPC) or twice daily (mCRPC).

Primary Outcome Measure

Pharmacokinetics (PK) of Abiraterone Decanoate in Plasma: Maximum Concentration (Cmax) [ Time Frame: Up to 6 months ]

Central Contacts

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