Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase2

A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer

Sponsor: Astellas Pharma Global Development, Inc.

NCT ID: NCT07005154

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
ASP5541 (drug), Prednisone (drug), Prednisolone (drug), abiraterone acetate (drug)
How long the study runs
Study runs about 81 months (dates as stated)
About the drug or intervention
ASP5541 — drug: Intramuscular Injection · Prednisone — drug: Oral · Prednisolone — drug: Oral · abiraterone acetate — drug: Oral · Adrenocorticotropic hormone — drug: Intramuscular or intravenous injection
Patient visit burden
Not specified by the sponsor

In plain English

This is a Phase 2 study looking at the effects of a study drug called ASP5541 in men with prostate cancer that has spread to other parts of the body. It includes two groups: men whose cancer still responds to hormone therapy (metastatic hormone sensitive prostate cancer) and men whose cancer no longer responds to it (metastatic castration-resistant prostate cancer). The study is funded by Astellas Pharma Global Development, Inc.

Who can take part

  • Men with prostate cancer (a type called adenocarcinoma) that has spread, confirmed by a tissue sample and by scans such as a bone scan, CT, MRI or PSMA-PET.
  • Generally able to carry out normal daily activities (performance status 0 or 1); a score of 2 is allowed if this is due to bone pain.
  • Expected to live at least 12 months (hormone sensitive disease) or at least 6 months (hormone resistant disease).
  • Already having hormone therapy (ADT) by injection or having had surgery to remove the testicles; men with hormone sensitive disease must have started this at least 14 days before the first dose.
  • Men with hormone resistant disease must show their cancer is growing (on scans or PSA blood tests) and have a low testosterone level at screening.
  • Able and willing to follow all study requirements, including using contraception and not donating sperm during treatment and for 7 months after the last dose.
  • Normal blood potassium at screening without supplements, and agreement not to join another treatment study at the same time.

Who may not be able to

  • Cancer that has spread to the brain or spinal cord, unless it has been treated, is stable, and steroid tablets are not needed.
  • Another cancer that needs treatment, apart from some treated skin cancers, very early stage cancers, or cancers cleared for 5 or more years.
  • Significant heart problems, for example poorly controlled irregular heartbeat, long QT syndrome, a certain length on a heart trace (QTcF of 450 milliseconds or more), serious heart failure, recent angina or heart attack, uncontrolled blood pressure, or recent blood clots (exact rules differ by study group).
  • Ongoing side effects from earlier treatment rated above Grade 2, or major surgery in the last 30 days or planned during the study.
  • Fever or a significant infection in the last 28 days, or a blood transfusion in the last month.
  • Problems with the pituitary or adrenal glands (for example Addison's disease or Cushing's syndrome).
  • Poorly controlled diabetes (based on an HbA1c blood test result).
  • Liver problems, including jaundice, hepatitis B or C, or moderate to severe liver damage.
  • HIV infection, or a body mass index above 40.
  • Drug or alcohol misuse within the last 2 years.
  • Steroid tablets above a certain dose (more than 10 mg prednisone a day) in the last 4 weeks; steroid creams, inhalers and joint injections are allowed.
  • Herbal products with known anti-cancer or prostate effects (for example saw palmetto, St. John's wort or turmeric) in the last 4 weeks, or during the study.
  • Certain hormone-blocking prostate cancer drugs (such as ketoconazole, abiraterone or other CYP17 inhibitors) in the last 4 weeks, or strong CYP3A4-affecting medicines in the last 4 weeks or during the study.
  • High-dose biotin (vitamin B7) supplements above 30 micrograms a day.
  • For hormone resistant disease: recent prostate cancer treatment including hormone therapy, chemotherapy, biological therapy, immunotherapy or radiotherapy within set time windows.
  • For hormone sensitive disease: most previous drug treatment, radiotherapy or surgery for spread prostate cancer, with limited exceptions (some allowed ADT, one course of palliative radiotherapy or surgery, or up to 6 cycles of docetaxel under certain conditions).
  • Any experimental treatment in the last 4 weeks, or previous treatment with ASP5541.
  • Blood counts below set levels, or blood clotting (INR) results above set limits, at screening.
  • Liver or kidney blood tests outside set limits, or low blood albumin.
  • Known allergy to ASP5541, prednisone, or the ingredients of the medicines used.
  • A stomach or bowel problem that affects how medicines are absorbed.

What taking part involves

  • • Taking the study drug ASP5541.
  • • Continuing hormone therapy (ADT) with injections, or having already had surgical removal of the testicles, during the study.

Time commitment: Not stated — ask the trial team (the data does not say how long the study lasts, how often visits happen, or how ASP5541 is given).

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
Male
Number of participants
218
Started
2025-08-19
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for prostate cancer
  • • Phase2 - 218 participants
  • • Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with prostate cancer
  • • Male only

Where?

  • • London - Site GB44003

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of the main male sex hormone, testosterone in the body. Androgen receptor pathway inhibitors (ARPIs) are another type of hormone therapy. They either slow down how much testosterone is made or block testosterone from reaching the prostate cancer cells. Abiraterone acetate (AA) is an ARPI that is used to treat advanced prostate cancer. This type of treatment is usually given as a tablet with a steroid called prednisone/prednisolone to manage any medical problems from the hormone therapy. ASP5541 is a different form of abiraterone acetate. It is given as an injection into the muscle. In this study, ASP5541 will be given to men with advanced prostate cancer, both with and without prednisone/prednisolone. This study will check the safety of ASP5541 and compare how well ASP5541 works in men with advanced prostate cancer compared to abiraterone acetate. The main aims of the study are: * To check how well ASP5541 with prednisone/prednisolone works compared to AA with prednisone/prednisolone in men with advanced prostate cancer who haven't previously been treated with an ARPI. * To check the safety of ASP5541 given by itself in men with advanced prostate cancer that haven't previously been treated with an ARPI. * To check how well ASP5541 given by itself works compared to AA with prednisone/prednisolone in men with advanced prostate cancer that haven't previously been treated with an ARPI. * To check the safety of ASP5541 with prednisone/prednisolone in Japanese men with advanced prostate cancer. Adult men with a certain type of advanced prostate cancer can take part. Their cancer has spread to other parts of the body (metastatic). The different types are: * Metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer that needs testosterone to grow. * Metastatic castration-resistant prostate cancer (mCRPC). Prostate cancer that continues to grow even when testosterone levels are low. In this study there will be 3 treatment groups: * In Group 1, men with mCRPC who haven't previously been treated with an androgen receptor pathway inhibitor will either be given ASP5541 and prednisone/prednisolone or be given abiraterone acetate and prednisone/prednisolone. * In Group 2, men with mHSPC who haven't previously been treated with an androgen receptor pathway inhibitor will either be given ASP5541 by itself or be given abiraterone acetate with prednisone/prednisolone. * In Group 3, Japanese men with mCRPC or mHSPC who may or may not have previously been treated with an androgen receptor pathway inhibitor will be given ASP5541 with prednisone/prednisolone. ASP5541 will be given as an injection into a muscle every 12 weeks. Men with mCRPC will take prednisone/prednisolone twice daily and men with mHSPC will take prednisone/prednisolone once daily. Abiraterone acetate will be given as tablets to be taken once daily. All groups will also receive the standard of care treatment, such as androgen deprivation therapy. The men in the study will visit their clinic regularly during and after treatment for health checks, including checking for any medical problems. Some men (Group 2) will check their blood pressure weekly at home. On some visits they will also have scans to check for any changes in their cancer. The number of visits and type of safety checks done at each visit will depend on the health of each person and when they completed their treatment.

Prostate CancerMetastatic Castration-Resistant Prostate CancerMetastatic Hormone Sensitive Prostate Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Male only
  • How fit you need to be: ECOG 0 or better

Biomarkers mentioned

PSAIgM positiveantigen positiveantibody positive

Treatment history

Treatments you must have had:

  • ✓ an estimated life expectancy of ≥ 12 months with mHSPC or ≥ 6 months with mCRPC
  • ✓ started castration therapy (medical or surgical) at least 14 days
  • ✓ a plan to maintain effective GnRH analogue therapy for the duration of the study

What the study is looking for

  • ✓Participant is diagnosed with confirmed by testing a sample adenocarcinoma of the prostate without...
  • ✓Participant has Fit enough for normal activity (ECOG 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 mHSPC or ≥ 6 months with mCRPC.
  • ✓Participant is able to understand and comply with all study requirements and procedures.
  • ✓Note: Participant who has not had a bilateral orchiectomy must have a plan to maintain effective GnRH analogue...

Who cannot take part

  • ✗Participant has a known additional cancer beyond prostate cancer that requires active treatment with the...
  • ✗Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type
  • ✗Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for...
  • ✗Any other cancer from which the participant has been disease-free for ≥5 years
  • ✗Participant has clinically significant heart disease, defined as any of the following:
See the full criteria
Inclusion Criteria: * Participant is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features. * Participant has 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 mHSPC or ≥ 6 months with mCRPC. * Participant is able to understand and comply with all study requirements and procedures. * Participant has been diagnosed with mCRPC or mHSPC documented by metastatic lesions on a bone scan, computed tomography (CT), magnetic resonance imaging (MRI) or prostate-specific membrane antigen positron emission tomography (PSMA-PET). * Participant is receiving ongoing ADT with a gonadotropin-releasing hormone (GnRH) analogue or has a history of bilateral orchiectomy (i.e., surgical or medical castration). Participant with mHSPC must have started castration therapy (medical or surgical) at least 14 days prior to Cycle 1 Day 1 (C1D1). Note: Participant who has not had a bilateral orchiectomy must have a plan to maintain effective GnRH analogue therapy for the duration of the study. * If the participant has mCRPC, participant has evidence of disease progression defined as 1 or more of the following criteria at study entry: * Evidence of radiographic progression of disease prior to first dose and following the most recent prostate cancer treatment, defined as progressive disease on CT/MRI per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or on a bone scan per PCWG3. * PSA progression defined as an increase in PSA of at least 25% and ≥ 1 ng/mL above the nadir, confirmed by a second value 1 week later, and with at least 1 of the measurements within 90 days prior to screening. PSA nadir is defined as the lowest PSA during or after the most recent treatment. * If the participant has mCRPC, participant has a serum testosterone level \< 1.73 nmol/L (\< 50 ng/dL) at the Screening visit. * Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 7 months after final ASP5541 administration. * Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 7 months after final ASP5541 administration. * Male participant must not donate sperm during the treatment period and for 7 months after final ASP5541 administration. * Participant agrees not to participate in another interventional study while receiving ASP5541 in the present study. * Participant should have normal serum potassium (within the local laboratory normal range) at screening without supplementation. Exclusion Criteria: * Participant has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data. * Participant has known active central nervous system (CNS) metastases. Note: Participant with CNS metastases who has been treated with surgery and/or radiation therapy, who is off pharmacologic doses of glucocorticoids and who is neurologically stable is eligible. * Participant has a known additional malignancy beyond prostate cancer that requires active treatment with the exception of any of the following: * Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of any type * Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥ 2 years * Any other cancer from which the participant has been disease-free for ≥5 years * Participant has clinically significant cardiac disease, defined as any of the following: * Clinically significant cardiac arrhythmias including bradyarrhythmia which are poorly controlled. Rate-controlled atrial fibrillation is permitted. * Congenital long QT syndrome. * QT interval corrected by Fridericia's formula (QTcF) ≥450 msec at Screening. If the QT interval corrected for heart rate intervals (QTc) is prolonged in a participant with a pacemaker or bundle branch block, the participant may be enrolled in the study if confirmed by the medical monitor. * History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II or left ventricular ejection fraction measurement of \< 50% at baseline. * Cohorts 1 and 3: Participant must not have unstable angina (symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months. * Cohort 2: Participants must not have symptomatic heart failure, unstable or new-onset angina or myocardial infarction within the past 12 months. * Cohorts 1 and 3: Uncontrolled hypertension, defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg that has been confirmed by 2 successive measurements despite optimal medical management. * Cohort 2: Uncontrolled hypertension, defined as systolic BP \> 140 mmHg or diastolic BP \> 90 mmHg that has been confirmed by 2 successive measurements despite optimal medical management. Participants may be receiving a maximum of 2 antihypertensives that were initiated at least 3 months prior to Cycle 1 Day 1. * Cohort 1 and 3: Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 3 months before start of study medication (except for adequately treated catheter related venous thrombosis occurring \> 1 month before Cycle 1 Day 1). * Cohort 2: Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within the last 12 months. * Participant has any unresolved National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 5.0) Grade \> 2 toxicity at the Screening visit. Note: Participant receiving ongoing hormone replacement therapy for endocrine immune-related AEs without clinical symptoms will not be excluded. * Participant has had major surgery (e.g., requiring general anesthesia) within 30 days before screening, or has not fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study. * Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day 1. * Participant received a blood transfusion within 1 month of the first dose of study intervention. * Participant has a history of impaired pituitary or adrenal gland function (e.g., Addison's disease, Cushing's syndrome). * Participant has hemoglobin A1c (HbA1c) \> 10% (if diabetes mellitus was previously diagnosed) or HbA1c \> 8% (if diabetes mellitus was previously undiagnosed). (Excluded participant may be rescreened after referral and evidence of improved control of their condition.) * Participant has jaundice or known current active liver disease from any cause, including hepatitis A (hepatitis A virus IgM positive, but testing for hepatitis A in screening is not required), hepatitis B (hepatitis B virus surface antigen positive, confirmed by hepatitis B virus DNA), or hepatitis C (hepatitis C virus antibody positive, confirmed by hepatitis C virus RNA). * Participant has moderate or severe hepatic impairment (Child-Pugh Class B or C). * Participant has a known history of human immunodeficiency virus (HIV) infection (HIV antibody positive). * Participant has a body mass index \> 40 kg/m2. * Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria within 2 years before screening. * Participant received treatment with glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to C1D1. The use of topical, intraocular, inhalational, intranasal or intra-articular glucocorticoids is permitted. * Participant received treatment with herbal medications with known anti-cancer properties or known effects on prostate physiology within 4 weeks prior to Cycle 1 Day 1 (e.g., saw palmetto, St. John's wort, turmeric/curcumin). Participants must agree not to use herbal products during study participation. * Participant is receiving current treatment with systemic ketoconazole, abiraterone acetate (AA) or any other cytochrome P450 17A1 (CYP17) inhibitor. Participant who has received systemic ketoconazole, AA or any other CYP17 inhibitor must have discontinued these agents ≥ 4 weeks prior to the first dose of study intervention. * Participant received prior systemic treatment with a strong inducer or inhibitor of cytochrome p450 3A4 (CYP3A4) within 4 weeks of first dose of study intervention. Concomitant use of strong inducers or inhibitors of CYP3A4 are not permitted on study. * Participant requires use of biotin (i.e., vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg. Note: Participant who switches from a high dose to a dose of 30 μg/day or less prior to first dose of study drug is eligible for study entry. * Participant is required to use any prohibited medication on the List of Excluded Concomitant Medications. * For mCRPC participants only: Participant has been treated with any of the following for prostate cancer, during the indicated time frame prior to enrollment: * Hormonal therapy (e.g., androgen receptor blockers \[AR\] antagonists, second-generation androgen receptor pathway inhibitors \[including enzalutamide, apalutamide, darolutamide, rezvilutamide and AA\], 5-alpha reductase inhibitors, estrogens, cyproterone acetate) within 4 weeks of C1D1. Note: Participant has been treated with bicalutamide within 6 weeks prior to enrollment is not permitted. Participant has been treated with all other GnRH analogues or antagonists is permitted. * Chemotherapy within 2 weeks or 5 half-lives of C1D1 (whichever is longer) * Biologic therapy within 4 weeks of C1D1 * Immunotherapy within 4 weeks of C1D1 * Radiation therapy (includes radioligands) within 4 weeks of C1D1 * For mHSPC participants only: Participant has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted): * Up to 4 months of ADT with GnRH agonists or antagonists or orchiectomy (within 3 months prior to C1D1) with or without concurrent antiandrogens. * Participant may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to C1D1. * Up to 6 cycles of docetaxel therapy, with the last dose of docetaxel ≤ 2 months prior to C1D1. A participant who has received docetaxel should have maintained a response to docetaxel of stable disease or better, by imaging and PSA, prior to C1D1. * Up to 6 months of ADT with GnRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to C1D1 if subject was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to C1D1. * Participant has received any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to C1D1. * Participant has received ASP5541 previously. * Participant has absolute neutrophil count \< 1500/μL, platelet count \< 100000/μL or hemoglobin \< 9 g/dL (6.2 mmol/L) or international normalized ratio (INR) ≥ 1.5 (unless participant is taking oral anticoagulants in which case INR ≤ 2.0 is permitted) at Screening. Note: Participant may not have received any growth factors within 7 days or blood transfusions within 28 days prior to the hematology values obtained at Screening. * Participant has serum total bilirubin \> 1.5 x upper limit of normal (ULN) (or \> 3 x ULN for participants with documented Gilbert's disease), or serum alanine aminotransferase or aspartate aminotransferase \> 2.5 x ULN at Screening. * Participant does not have adequate renal function defined as a calculated creatinine clearance \< 30 mL/min as determined by a validated algorithm for calculating creatinine clearance. * Participant has serum albumin \< 3.0 g/dL (30 g/L) at Screening. * Participant has a known or suspected hypersensitivity to ASP5541, prednisone, or any components of the formulations used. * Participant has a gastrointestinal disorder affecting absorption.

Where Is This Study? (1 UK site)

Site GB44003

London, United Kingdom

Recruiting

How to Get in Touch

Astellas Pharma Global Development, Inc.

Sponsor contact

CONTACT

800-888-7704 Astellas.registration@astellas.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08