Comparing Opevesostat with Abiraterone acetate for prostate cancer metastatic

Exclusion

• −Has concurrent active HBV or known active HCV infection
• −Has a gastrointestinal disorder that might affect absorption
• −Has a history of pituitary dysfunction
• −Has poorly controlled diabetes mellitus
• −Has clinically significant abnormal serum potassium or sodium level
• −Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
• −Has a history of seizure within 6 months of providing documented informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → or any condition that may predispose to seizures within 12 months before the date of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
• −Has a history of clinically significant ventricular arrhythmias
• −Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) due to mAbs administered more than 4 weeks before the date of randomization
• −Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate, citrus pectin polysaccharide) within 4 weeks before the date of randomization
• −Has received radium-223 or Lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baselineBaselineYour starting measurements, taken before treatment begins.Read more → from AEs due to radium-223 or Lutetium-177 administered more than 4 weeks before the date of randomization
• −Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization
• −Has received colony-stimulating factors within 28 days before the date of randomization
• −Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization
• −Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks
• −Has a "superscan" bone scan
• −Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
• −Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• −Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• −Has an active autoimmune disease that has required systemic treatment in past 2 years
• −Has an active infection requiring systemic therapy
• −Has a history of long QTc syndrome
• −Has any of the following at Screening VisitScreeningThe checks done before joining, to see whether a study fits.Read more →: hypotension (systolic BP \<110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy)
• −Is unable to swallow capsules/tablets
• −Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures
• −Received prior systemic anticancer therapy including investigational agents 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
• −Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe, carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfinavir, atazanavir, glecaprevir-pibrentasvir, simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle \[Silybum marianum\])
• −Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention
• −Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications
• −Participants who have not adequately recovered from major surgery or have ongoing surgical complications
• −Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
• −Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids