Actively Recruiting
A Phase 2 Open-label Multi-cohort Study to Assess the Safety and Efficacy of ASP5541 in Men With Advanced Prostate Cancer
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-05-01
218
Participants Needed
33
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of ASP5541, a new injectable form of abiraterone acetate, in men with advanced prostate cancer. This study focuses on men with metastatic hormone-sensitive prostate cancer (mHSPC) or metastatic castration-resistant prostate cancer (mCRPC) who have not previously been treated with androgen receptor pathway inhibitors (ARPIs). The study aims to compare ASP5541 with the standard oral abiraterone acetate combined with prednisone or prednisolone and assess ASP5541's safety alone and with steroids. Participants are divided into three groups: men with mCRPC receiving either ASP5541 plus prednisone/prednisolone or abiraterone acetate plus prednisone/prednisolone; men with mHSPC receiving either ASP5541 alone or abiraterone acetate plus prednisone/prednisolone; and Japanese men with mCRPC or mHSPC receiving ASP5541 with prednisone/prednisolone. ASP5541 is given by intramuscular injection every 12 weeks, prednisone/prednisolone is taken orally once or twice daily depending on cancer type, and abiraterone acetate is taken daily as a tablet. All participants continue standard care, including androgen deprivation therapy. During and after treatment, participants will have regular clinic visits for health checks, scans to monitor cancer progression, and safety assessments. Some men will monitor blood pressure weekly at home. Researchers will measure outcomes such as prostate-specific antigen (PSA) levels, adverse events, heart function, and overall health status up to several years. The study includes long-term follow-up to assess progression-free survival and treatment responses.
CONDITIONS
Brief Title
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participant 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
- Estimated life expectancy of at least 12 months for mHSPC or 6 months for mCRPC
- Able to understand and follow all study procedures
- Diagnosed with metastatic castration-resistant or hormone-sensitive prostate cancer confirmed by imaging
- Currently receiving androgen deprivation therapy or has had surgical castration; mHSPC participants must have started castration therapy at least 14 days before first treatment
- For mCRPC, evidence of disease progression by imaging or rising PSA levels
- For mCRPC, serum testosterone level below 1.73 nmol/L at screening
- Male participants agree to use contraception or abstain during treatment and for 7 months after final dose
- Male participants agree not to donate sperm during treatment and for 7 months after final dose
- Not participating in another interventional study during this trial
- Normal serum potassium at screening without supplementation
You will not qualify if you...
- Any disease, infection, or condition that increases risk or complicates study participation
- Active central nervous system metastases unless treated and stable
- Other active cancers requiring treatment, except certain treated skin or early-stage cancers in remission
- Significant heart conditions including poorly controlled arrhythmias, long QT syndrome, recent heart attack, or heart failure greater than NYHA Class II
- Uncontrolled hypertension as defined by specific blood pressure thresholds
- Recent arterial or venous thrombotic or embolic events within specified timeframes
- Ongoing Grade > 2 adverse events or unresolved toxicities
- Recent major surgery or planned surgery during study participation
- Recent febrile illness or active infection within 28 days before treatment
- Recent blood transfusion within 1 month before treatment
- Impaired pituitary or adrenal function
- High hemoglobin A1c levels indicating uncontrolled diabetes
- Current active liver disease or moderate to severe hepatic impairment
- Known HIV infection
- Body mass index over 40 kg/m2
- Drug or alcohol abuse within 2 years before screening
- Recent use of systemic glucocorticoids over 10 mg prednisone equivalent
- Recent use of herbal medications affecting prostate or cancer
- Current treatment with certain hormone therapies or CYP inhibitors
- Use of prohibited medications
- Specific prior treatments within defined timeframes before enrollment
- Prior treatment with ASP5541
- Low blood counts or abnormal laboratory values
- Known hypersensitivity to study drugs
- Gastrointestinal disorders affecting drug absorption or metabolism
- For mCRPC and mHSPC, treatment history restrictions as specified in protocol details
- Participation in another investigational therapy within 4 weeks before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 37 months
Participants receive active drug treatments including ASP5541 every 12 weeks, prednisone or prednisolone orally twice daily, abiraterone acetate orally once daily, or a combination depending on cohort assignment.
Visits every 12 weeks aligned with ASP5541 dosing and additional visits for oral medication monitoring
Duration - Up to 84 months
Participants are monitored for safety, adverse events, and treatment efficacy after treatment completion.
Periodic visits for up to 84 months
Trial Site Locations
Total: 33 locations
1
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
Actively Recruiting
2
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
Associated Urological Specialists
Chicago Ridge, Illinois, United States, 60415
Actively Recruiting
4
Ochsner Health - Ochsner Medical Center - New Orleans
New Orleans, Louisiana, United States, 70121
Actively Recruiting
5
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
6
Solaris Health - The Urology Group
Cincinnati, Ohio, United States, 45212
Actively Recruiting
7
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
8
Tennessee Oncology Nashville
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908-07
Actively Recruiting
10
UW Health Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
11
Subei People's Hospital
Yangzhou, Jiangsu, China, 225001
Actively Recruiting
12
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China, 300211
Actively Recruiting
13
Huai'an First People's Hospital
Huaian, China, 211731
Actively Recruiting
14
Renji Hospital Shanghai Jiaotong Univ School of Medicine
Shanghai, China, 200127
Actively Recruiting
15
Site FR33004
Strasbourg, France
Actively Recruiting
16
Site DE49004
Nürtingen, Baden-Wurttemberg, Germany
Actively Recruiting
17
Site DE49001
Heinsberg, Germany
Actively Recruiting
18
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Actively Recruiting
19
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Actively Recruiting
20
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan
Actively Recruiting
21
The Cancer Institute Hospital of JFCR
Koto, Tokyo, Japan
Actively Recruiting
22
Harasanshin Hospital
Fukuoka, Japan
Actively Recruiting
23
Osaka International Cancer Institute
Osaka, Japan
Actively Recruiting
24
PanOncology Trials
San Juan, Puerto Rico
Actively Recruiting
25
Site KR82008
Gwangju, South Korea
Actively Recruiting
26
Site KR82002
Seoul, South Korea
Actively Recruiting
27
Site KR82003
Seoul, South Korea
Actively Recruiting
28
Site KR82004
Seoul, South Korea
Actively Recruiting
29
Site KR82007
Seoul, South Korea
Actively Recruiting
30
Site ES34006
Barcelona, Catalonia, Spain
Actively Recruiting
31
Site TW88603
Kaohsiung City, Taiwan
Actively Recruiting
32
Site TW88602
Taipei, Taiwan
Actively Recruiting
33
Site GB44003
London, United Kingdom
Actively Recruiting
Research Team
A
Astellas Pharma Global Development, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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