A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
Public ClinicalTrials.gov record NCT07005154. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Open-label, Multi-cohort Study to Assess the Efficacy and Safety of ASP5541 in Participants With Advanced Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07005154
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 218 participants
Conditions and interventions
Conditions
Interventions
- ASP5541 Drug
- Prednisone Drug
- Prednisolone Drug
- abiraterone acetate Drug
- Adrenocorticotropic hormone Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 18, 2025
- Primary completion
- May 30, 2032
- Completion
- May 30, 2032
- Last update posted
- Aug 20, 2026
2025 – 2032
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | 35805 | Recruiting |
| Sharp HealthCare - Sharp Memorial Hospital | San Diego | California | 92123 | Recruiting |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | Recruiting |
| Associated Urological Specialists | Chicago Ridge | Illinois | 60415 | Recruiting |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | Recruiting |
| Ochsner Health - Ochsner Medical Center - New Orleans | New Orleans | Louisiana | 70121 | Recruiting |
| New Mexico Oncology Hematology Consultants | Albuquerque | New Mexico | 87109 | Recruiting |
| Solaris Health - The Urology Group | Cincinnati | Ohio | 45212 | Recruiting |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | Recruiting |
| Tennessee Oncology Nashville | Nashville | Tennessee | 37203 | Recruiting |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908-07 | Recruiting |
| UW Health Carbone Cancer Center | Madison | Wisconsin | 53792 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07005154, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07005154 live on ClinicalTrials.gov.