OncoMatch/Clinical Trials/NCT07005154
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
Is NCT07005154 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for prostate cancer.
Treatment: ASP5541 · Prednisone · Prednisolone · abiraterone acetate · Adrenocorticotropic hormone — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: androgen deprivation therapy (GnRH analogue, bilateral orchiectomy) — ongoing or prior
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).
Cannot have received: CYP17 inhibitor (ketoconazole, abiraterone acetate)
Exception: must have discontinued ≥ 4 weeks prior to first dose
Participant is receiving current treatment with systemic ketoconazole, abiraterone acetate (AA) or any other cytochrome P450 17A1 (CYP17) inhibitor. Participant who has received systemic ketoconazole, AA or any other CYP17 inhibitor must have discontinued these agents ≥ 4 weeks prior to the first dose of study intervention.
Cannot have received: strong CYP3A4 inducer or inhibitor
Exception: must have discontinued ≥ 4 weeks prior to first dose
Participant received prior systemic treatment with a strong inducer or inhibitor of cytochrome p450 3A4 (CYP3A4) within 4 weeks of first dose of study intervention. Concomitant use of strong inducers or inhibitors of CYP3A4 are not permitted on study.
Cannot have received: investigational therapy
Exception: must have discontinued ≥ 4 weeks or 5 half-lives (whichever is longer) prior to C1D1
Participant has received any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to C1D1.
Cannot have received: ASP5541 (ASP5541)
Participant has received ASP5541 previously.
Lab requirements
Blood counts
absolute neutrophil count ≥ 1500/μL, platelet count ≥ 100000/μL, hemoglobin ≥ 9 g/dL, INR < 1.5 (unless on oral anticoagulants, then INR ≤ 2.0), serum albumin ≥ 3.0 g/dL
Kidney function
calculated creatinine clearance ≥ 30 mL/min
Liver function
serum total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN for Gilbert's disease), ALT/AST ≤ 2.5 x ULN, no moderate or severe hepatic impairment (Child-Pugh Class B or C), no active liver disease
Cardiac function
QTcF < 450 msec, no congenital long QT syndrome, no clinically significant cardiac arrhythmias (except rate-controlled atrial fibrillation), no NYHA Class III/IV heart failure, LVEF ≥ 50%, no recent MI/unstable angina per cohort, no uncontrolled hypertension per cohort, no recent thrombotic/embolic events per cohort
See exclusion criteria: QTcF ≥450 msec, congenital long QT syndrome, significant arrhythmias, NYHA > II, LVEF < 50%, unstable angina/MI/thrombotic events, uncontrolled hypertension, see cohort-specific definitions. Absolute neutrophil count < 1500/μL, platelet count < 100000/μL, hemoglobin < 9 g/dL, INR ≥ 1.5 (unless on anticoagulants, then INR ≤ 2.0), serum albumin < 3.0 g/dL, serum total bilirubin > 1.5 x ULN (or > 3 x ULN for Gilbert's), ALT/AST > 2.5 x ULN, moderate/severe hepatic impairment, calculated creatinine clearance < 30 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- H. Lee Moffitt Cancer Center · Tampa, Florida
- New Mexico Oncology Hematology Consultants · Albuquerque, New Mexico
- Carolina Urologic Research Center · Myrtle Beach, South Carolina
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify