ClinicaliQ Trial Snapshot
- A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer — Recruiting • Phase II • Oncology • NCT07005154.
- What is being tested: ASP5541, a novel androgen receptor pathway inhibitor (ARPI), is being evaluated in a Phase 2 study as a potential treatment for prostate cancer, representing advancement beyond standard hormone therapy (ADT) approaches.
- Patient eligibility overview: The trial includes participants with prostate cancer who are candidates for hormone therapy; specific eligibility criteria typically encompass disease stage, prior treatment history, and adequate organ function to tolerate the investigational agent.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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…
Eligibility Snapshot
- : * Participant is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features. * 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. * Participant has been diagnosed with mCRPC or mHSPC documented by metastatic lesions on a bone scan, computed tomography (CT), magnetic resonance imaging (MRI) or prostate-specific membrane antigen positron emission tomography (PSMA-PET). * Participant is receiving ongoing ADT with a gonadotropin-releasing hormone (GnRH) analogue or has a history of bilateral orchiectomy (i.e., surgical or medical castration). Participant with mHSPC must have started castration therapy (medical or surgical) at least 14 days prior to Cycle 1 Day 1 (C1D1). Note: Participant who has not had a bilateral orchiectomy must have a plan to maintain effective GnRH analogue therapy for the duration of the study. * If the participant has mCRPC, participant has evidence of disease progression defined as 1 or more of the following…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.