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 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 fro

Trial Details

NCT ID

NCT07005154

Phase

PHASE2

Sponsor

Astellas Pharma Global Development, Inc.

Status

RECRUITING

Cancer Type

Prostate Cancer

Interventions

ASP5541
Prednisone
Prednisolone
abiraterone acetate
Adrenocorticotropic hormone

Locations (sample)

Huntsville, Alabama, United States|34.7304,-86.58594
Tampa, Florida, United States|27.94752,-82.45843
Chicago Ridge, Illinois, United States|41.70142,-87.77922
New Orleans, Louisiana, United States|29.95465,-90.07507
Albuquerque, New Mexico, United States|35.08449,-106.65114

Key Eligibility Criteria

Participant is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or sm…
Participant has ECOG performance status of 0 or 1, or ECOG performance status of 2 if due to bone pain.
Participant must have an estimated life expectancy of ≥ 12 months with mHSPC or ≥ 6 months with mCRPC.
Participant is able to understand and comply with all study requirements and procedures.

For full eligibility, visit ClinicalTrials.gov.

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