Actively Recruiting
A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-02-18
12
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with adenocarcinoma of the prostate without neuroendocrine or small cell features
- ECOG performance status 0 or 1, or 2 if due to bone pain
- Life expectancy of at least 12 months for metastatic hormone-sensitive prostate cancer or at least 6 months for metastatic castration-resistant prostate cancer
- Able to understand and follow study procedures
- Diagnosis of metastatic castration-resistant or hormone-sensitive prostate cancer confirmed by imaging
- Receiving ongoing ADT with GnRH analogue or history of bilateral orchiectomy; for metastatic hormone-sensitive prostate cancer, started castration therapy at least 14 days before study start
- Evidence of disease progression if metastatic castration-resistant prostate cancer
- Serum testosterone level below 1.73 nmol/L for metastatic castration-resistant prostate cancer
- Male agreeing to use contraception with female partners of childbearing potential during and for 7 months after treatment
- Male agreeing to abstain or use condom with pregnant partners during pregnancy and for 7 months after treatment
- Male not donating sperm during treatment and for 7 months after treatment
- Adequate ventrogluteal muscle mass for intramuscular injection
- Not participating in another interventional study while receiving ASP5541
You will not qualify if you...
- Any concurrent disease or condition that increases risk or complicates study participation
- Active central nervous system metastases unless treated, stable, and off glucocorticoids
- Additional active cancers requiring treatment, except certain treated skin cancers or cancers in remission
- Clinically significant cardiac disease including uncontrolled arrhythmias, congenital long QT syndrome, severe heart failure, recent angina, or recent myocardial infarction
- Uncontrolled hypertension despite treatment
- Recent arterial or venous thrombotic events
- Unresolved severe toxicity from prior treatments
- Major surgery within 90 days before screening or planned during study
- Recent febrile or symptomatic infections
- Recent blood transfusion
- Impaired pituitary or adrenal gland function
- Poorly controlled diabetes
- Active liver disease or moderate to severe hepatic impairment
- Known HIV infection
- Body mass index over 40 kg/m2
- Recent history of drug or alcohol abuse
- Recent treatment with glucocorticoids above 10 mg prednisone equivalent
- Recent use of certain traditional Chinese or herbal medicines with antitumor activity
- Current or recent treatment with systemic ketoconazole, abiraterone acetate, or CYP17 inhibitors
- Recent use of strong CYP3A4 inducers or inhibitors
- Use of biotin supplements above daily adequate intake
- Use of prohibited medications listed in the study
- Recent treatments for prostate cancer including hormonal therapy, chemotherapy, biologic therapy, immunotherapy, or radiation within specified time frames
- Previous use of ASP5541
- Low blood counts or coagulation abnormalities
- Elevated liver enzymes or bilirubin beyond specified limits
- Poor kidney function
- Low serum albumin
- Known or suspected allergy to study drugs
- Gastrointestinal disorders affecting absorption
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
A
Astellas Pharma Global Development, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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