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A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
NCT07005154 · View on ClinicalTrials.gov ↗
Study Summary
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 co
Conditions Studied
Interventions
- DRUG Prednisone
- DRUG abiraterone acetate
- DRUG Prednisolone
- DRUG ASP5541
- DRUG Adrenocorticotropic hormone
Study Locations (12)
Other
- Harasanshin Hospital — Fukuoka
- Osaka International Cancer Institute — Osaka
- PanOncology Trials — San Juan
- KR82008 — Gwangju
Tokyo
- Nippon Medical School Hospital — Bunkyo-ku
- The Cancer Institute Hospital of JFCR — Koto-ku
Florida
- H. Lee Moffitt Cancer Center — Tampa
New Mexico
- New Mexico Oncology Hematology Consultants — Albuquerque
South Carolina
- Carolina Urologic Research Center — Myrtle Beach
Baden-Wurttemberg
- DE49004 — Nürtingen
Chiba
- National Cancer Center Hospital East — Kashiwa
Shizuoka
- Shizuoka Cancer Center — Sunto-gun
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2025-06-19 |
| Est. Completion | 2032-05-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07005154
The ClinicalTrials.gov registry entry for NCT07005154 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 218 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 172 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 5 interventions — of which Prednisone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07005154 reports 12 study locations spanning 8 distinct geographic areas — top geographies include Other, Tokyo, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07005154 about?
NCT07005154 is a clinical study titled "A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer". 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 ...
What is the current status of trial NCT07005154?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 218 participants. The study started on 2025-06-19. Estimated completion is 2032-05-31.
What conditions does trial NCT07005154 study?
This clinical trial studies the following conditions: Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07005154?
The interventions under investigation include: Prednisone (DRUG), abiraterone acetate (DRUG), Prednisolone (DRUG), ASP5541 (DRUG), Adrenocorticotropic hormone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07005154?
This trial is sponsored by Astellas Pharma Global Development, which has 172 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07005154 being conducted?
This trial has 12 study locations across Florida, New Mexico, South Carolina, Baden-Wurttemberg, Chiba. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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