RecruitingPhase 2NCT07005154

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

A Phase 2, Open-label, Multi-cohort Study to Assess the Efficacy and Safety of ASP5541 in Participants With Advanced Prostate Cancer


Sponsor

Astellas Pharma Global Development, Inc.

Enrollment

218 participants

Start Date

Jun 19, 2025

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ASP5541 in men with prostate cancer that has spread to other parts of the body. The trial includes two groups: men with metastatic hormone-sensitive prostate cancer (mHSPC, where the cancer still responds to hormone therapy) and men with metastatic castration-resistant prostate cancer (mCRPC, where it no longer does). **You may be eligible if...** - You are a man with confirmed prostate adenocarcinoma that has spread (metastatic disease) - You are currently on androgen deprivation therapy (ADT/hormone therapy) or have had surgical castration - Your overall health is good (ECOG 0–1, or 2 if bone pain is the reason) - You have at least 12 months life expectancy (mHSPC) or 6 months (mCRPC) - For mCRPC: you have evidence of disease progression despite hormone therapy **You may NOT be eligible if...** - You have prostate cancer with neuroendocrine features or small cell type - Your cancer has not progressed while on hormone therapy (for the mCRPC group) - You do not meet organ function or other medical eligibility criteria per the protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGASP5541

Intramuscular Injection

DRUGPrednisone

Oral

DRUGPrednisolone

Oral

DRUGabiraterone acetate

Oral

DRUGAdrenocorticotropic hormone

Intramuscular or intravenous injection


Locations(33)

Clearview Cancer Institute

Huntsville, Alabama, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Associated Urological Specialists

Chicago Ridge, Illinois, United States

Ochsner Health - Ochsner Medical Center - New Orleans

New Orleans, Louisiana, United States

New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, United States

Solaris Health - The Urology Group

Cincinnati, Ohio, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Tennessee Oncology Nashville

Nashville, Tennessee, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

UW Health Carbone Cancer Center

Madison, Wisconsin, United States

Subei People's Hospital

Yangzhou, Jiangsu, China

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Huai'an First People's Hospital

Huaian, China

Renji Hospital Shanghai Jiaotong Univ School of Medicine

Shanghai, China

Site FR33004

Strasbourg, France

Site DE49004

Nürtingen, Baden-Wurttemberg, Germany

Site DE49001

Heinsberg, Germany

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, Japan

The Cancer Institute Hospital of JFCR

Koto, Tokyo, Japan

Harasanshin Hospital

Fukuoka, Japan

Osaka International Cancer Institute

Osaka, Japan

PanOncology Trials

San Juan, Puerto Rico

Site KR82008

Gwangju, South Korea

Site KR82002

Seoul, South Korea

Site KR82003

Seoul, South Korea

Site KR82004

Seoul, South Korea

Site KR82007

Seoul, South Korea

Site ES34006

Barcelona, Catalonia, Spain

Site TW88603

Kaohsiung City, Taiwan

Site TW88602

Taipei, Taiwan

Site GB44003

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07005154


Related Trials