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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (1 UK site)
Site GB44003
London, United Kingdom
How to Get in Touch
Astellas Pharma Global Development, Inc.
Sponsor contactCONTACT
