Condition: Prostate Cancer · Metastatic Castration-Resistant Prostate Cancer · Metastatic Hormone Sensitive Prostate Cancer · Sponsor: Astellas Pharma Global Development, Inc.
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.
Astellas Pharma Global Development, Inc. · 800-888-7704 · Astellas.registration@astellas.com
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| Clearview Cancer Institute | Huntsville, Alabama, United States | Recruiting |
| Sharp HealthCare - Sharp Memorial Hospital | San Diego, California, United States | Recruiting |
| H. Lee Moffitt Cancer Center | Tampa, Florida, United States | Recruiting |
| Associated Urological Specialists | Chicago Ridge, Illinois, United States | Recruiting |
| NorthShore University HealthSystem | Evanston, Illinois, United States | Recruiting |
| Ochsner Health - Ochsner Medical Center - New Orleans | New Orleans, Louisiana, United States | Recruiting |
| New Mexico Oncology Hematology Consultants | Albuquerque, New Mexico, United States | Recruiting |
| Solaris Health - The Urology Group | Cincinnati, Ohio, United States | Recruiting |
| Carolina Urologic Research Center | Myrtle Beach, South Carolina, United States | Recruiting |
| Tennessee Oncology Nashville | Nashville, Tennessee, United States | Recruiting |
| University of Virginia Cancer Center | Charlottesville, Virginia, United States | Recruiting |
| UW Health Carbone Cancer Center | Madison, Wisconsin, United States | Recruiting |
+ 38 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07005154