Phase 3 Prostate Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with prostate cancer (a specific type called adenocarcinoma) confirmed through a tissue or cell sample
• People whose prostate cancer has continued to grow or spread while receiving hormone-suppressing treatment (androgen deprivation therapy, or ADT) or after surgical removal of both testicles, within the 6 months before screening
• People who have prostate cancer that has spread to other parts of the body, such as the bones or soft tissue, confirmed by bone scan, CT scan, or MRI
• People whose cancer continued to grow during or after treatment with at least one newer type of hormone-blocking medication (called a next-generation hormonal agent) for at least 8 weeks (or at least 14 weeks if bone progression was involved) — with specific conditions around prior chemotherapy use (confirm with trial site)
• People who have previously been treated with a type of drug called a PARP inhibitor, or whose treating doctor determined they were not suitable for it, or who chose not to receive it
• People who are still receiving ADT and have very low testosterone levels in their blood (below 50 ng/dL)
• People who are in generally good physical condition, rated 0 or 1 on a standard medical scale (ECOG), assessed within 10 days before being assigned to a treatment group
• People whose liver, kidneys, and other organs are functioning adequately
• People who are able to provide a fresh tissue sample from a biopsy of soft tissue that has not previously been treated with radiation (samples from tumors growing at a prior radiation site are allowed)
• People who have hepatitis B but have been on antiviral treatment for at least 4 weeks and have no detectable hepatitis B virus in their blood at the time of enrolment
• People with a history of hepatitis C whose hepatitis C virus is no longer detectable at screening
• People who experienced side effects from previous cancer treatments, where those side effects have largely resolved to a mild level or returned to their normal baseline — with some exceptions for certain hormone-related, nerve-related, or bone-related side effects (confirm with trial site)
• People living with HIV whose condition is well managed with antiviral medication

Who may not be able to join:

• People who have a condition affecting the gastrointestinal (digestive) system that could interfere with how the study medications are absorbed
• People who are unable to swallow capsules or tablets
• People who have a history of problems with the pituitary gland
• People who have poorly controlled diabetes
• People who have significantly abnormal potassium or sodium levels in their blood
• People who have low blood pressure (systolic below 110 mmHg) or high blood pressure that is not well controlled despite medication (systolic at or above 160 mmHg, or diastolic at or above 90 mmHg, recorded on 2 out of 3 measurements)
• People who have a history of active or unstable heart or blood vessel disease, including blood clots
• People who have a personal or family history of a heart rhythm condition called long QTc syndrome
• People who have had a seizure within 6 months before signing consent, or who have a condition that may increase the risk of seizure within 12 months before enrolment
• People who have a history of serious heart rhythm problems or certain types of heart block, unless they have a permanent pacemaker in place
• People who have previously received taxane-based chemotherapy (such as docetaxel or cabazitaxel) for castration-resistant prostate cancer
• People who have not fully recovered from a major surgery or who have ongoing surgical complications
• People currently taking certain anti-seizure medications that affect how the body processes drugs (CYP450-inducing antiepileptic drugs)
• People who have been on an unstable dose of thyroid hormone medication within 6 months before starting the study treatment, as determined by the treating doctor
• People who have received radiation therapy within 2 weeks before the first study dose, or who still have radiation-related side effects requiring steroid medication
• People who have received other systemic cancer treatments, including experimental treatments, within 4 weeks before the first study dose
• People who have taken certain medications that strongly affect drug processing in the body (strong CYP3A4 inducers or P-glycoprotein inhibitors) within 2 weeks before the first study dose
• People who have received a targeted cancer medication or a next-generation hormonal agent within 4 weeks before the first study dose
• People who have received a live vaccine within 30 days before the first study dose
• People who have used any other experimental drug or device within 4 weeks before starting study treatment
• People who have a known allergy or sensitivity to any of the study medications or their ingredients, including abiraterone acetate, prednisone, prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat
• People whose bone scan shows a pattern (called a "superscan") that would make it impossible to detect any new bone spread in the future
• People who have another cancer that is currently active or has required treatment within the past 3 years
• People who have an immune system disorder, or who have been taking high-dose steroid or other immune-suppressing medications within 7 days before the first study dose
• People who have active cancer spread to the brain or the lining of the brain — though people with previously treated and stable brain metastases may be considered (confirm with trial site)
• People who have an active autoimmune disease that has required systemic treatment within the past 2 years (replacement hormone therapy is generally permitted)
• People who have an active infection currently requiring treatment with systemic medication
• People who have both hepatitis B and hepatitis C infections active at the same time

Important: Always verify eligibility with the trial site directly before applying.