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Study identifier: NCT07005154 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Prostate Cancer · Metastatic Castration-Resistant Prostate Cancer · Metastatic Hormone Sensitive Prostate Cancer  ·  Sponsor: Astellas Pharma Global Development, Inc.

PhasePhase 2
Planned participants218
Who can joinMale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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…

This description comes directly from the study's public registry record.

Talk to the study team

Astellas Pharma Global Development, Inc.  ·  800-888-7704  ·  Astellas.registration@astellas.com

Always discuss trial participation with your own doctor first.

Locations (50)

Clearview Cancer InstituteHuntsville, Alabama, United StatesRecruiting
Sharp HealthCare - Sharp Memorial HospitalSan Diego, California, United StatesRecruiting
H. Lee Moffitt Cancer CenterTampa, Florida, United StatesRecruiting
Associated Urological SpecialistsChicago Ridge, Illinois, United StatesRecruiting
NorthShore University HealthSystemEvanston, Illinois, United StatesRecruiting
Ochsner Health - Ochsner Medical Center - New OrleansNew Orleans, Louisiana, United StatesRecruiting
New Mexico Oncology Hematology ConsultantsAlbuquerque, New Mexico, United StatesRecruiting
Solaris Health - The Urology GroupCincinnati, Ohio, United StatesRecruiting
Carolina Urologic Research CenterMyrtle Beach, South Carolina, United StatesRecruiting
Tennessee Oncology NashvilleNashville, Tennessee, United StatesRecruiting
University of Virginia Cancer CenterCharlottesville, Virginia, United StatesRecruiting
UW Health Carbone Cancer CenterMadison, Wisconsin, United StatesRecruiting

+ 38 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07005154