Comparing Opevesostat with Abiraterone acetate for metastatic castration-resistant prostate cancer (mcrpc)

Exclusion

• −Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat
• −Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention
• −Has concurrent active Hepatitis B virus and Hepatitis C virus infection
• −The main exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → include but are not limited to the following:
• −Has presence of gastrointestinal condition
• −Is unable to swallow capsules/tablets
• −Has history of pituitary dysfunction
• −Has poorly controlled diabetes mellitus
• −Has clinically significant abnormal serum potassium or sodium level
• −Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) \<110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy
• −Has a history of active or unstable cardio/cerebrovascular disease, including thromboembolic events
• −History or family history of long QTc syndrome
• −Has a history of seizure(s) within 6 months before providing documented informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
• −Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place
• −Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures
• −Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
• −Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention
• −Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention
• −Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• −Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
• −Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baselineBaselineYour starting measurements, taken before treatment begins.Read more → bone scan such that the presence of additional metastases in the future could not be evaluated
• −Has known additional malignancy that is progressing or has required active treatment within the past 3 years
• −Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
• −Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed
• −Active infection requiring systemic therapy
• −Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)
• −Has not adequately recovered from major surgery or have ongoing surgical complications
• −Participants on an unstable dose of thyroid hormone therapy, as judged by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, within 6 months before the start of the study intervention
• −Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids