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, not small cell type), confirmed by a lab test on a tissue or cell sample.
• People whose prostate cancer continued to grow or spread while receiving hormone-suppressing treatment (or after surgical removal of both testicles) within the 6 months before the screening visit.
• People who have prostate cancer that has spread to distant parts of the body, such as bones or soft tissue, confirmed by a bone scan and/or CT or MRI scan.
• People whose cancer got worse during or after treatment with one newer type of hormone-blocking drug (called a novel hormonal agent).
• People who have received one or two chemotherapy treatments containing a taxane drug for their advanced prostate cancer, and whose cancer continued to grow during or after that treatment.
• People who still have very low levels of the male hormone testosterone (below 50 ng/dL) due to ongoing hormone-suppressing treatment.
• People who are able to provide a fresh tissue sample (biopsy) from a soft tissue area that has not been previously treated with radiation.
• People who are in reasonably good physical condition, rated 0 or 1 on a standard health scale (meaning fully active or able to carry out light activity), assessed within 7 days before being randomly assigned to a treatment group.
• People who have already received a type of drug called a PARP inhibitor, or whose doctor determined they were not suitable for it, or who chose not to receive it.
• People who have already received a specific radioactive treatment called 177Lu-PSMA-617, or whose doctor determined they were not suitable for it, or who chose not to receive it.
• People who have not received a chemotherapy drug called cabazitaxel may still be considered if their doctor determined they were not suitable for it, or if they chose not to receive it.
• People who previously took an older type of hormone-blocking drug (first-generation anti-androgen), provided enough time has passed since the last dose (more than 4 weeks after flutamide, or more than 6 weeks after bicalutamide or nilutamide).
• People taking bone-strengthening medications (such as bisphosphonates or denosumab) who have been on a stable dose for at least 4 weeks before being assigned to a treatment group.
• People living with HIV, provided their HIV is well controlled with antiviral medication.
• People who carry the hepatitis B virus, provided they have been on antiviral treatment for at least 4 weeks and the virus is undetectable in their blood before the assignment date.
• People with a history of hepatitis C infection, provided the virus is undetectable at the screening visit.
• People who can produce sperm must agree to either abstain from sexual activity or use a condom during the study treatment and for a specified period after the last dose of each study drug (at least 7 days after opevesostat, at least 30 days after abiraterone acetate, and at least 3 months after enzalutamide).

Who may not be able to join:

• People with a digestive or bowel condition that could affect how the body absorbs medication.
• People with a history of problems with the pituitary gland.
• People with poorly controlled diabetes.
• People with significantly abnormal potassium or sodium levels in their blood.
• People with a history of active or unstable heart or blood vessel disease, including blood clots.
• People who have had a seizure within 6 months before signing the consent form, or any condition that could increase the risk of seizures within 12 months before the assignment date.
• People with a history of serious irregular heartbeat (ventricular arrhythmia).
• People who have received a cancer-fighting antibody treatment within 4 weeks before the assignment date, or who have not yet recovered from side effects of such treatment given more than 4 weeks ago.
• People who have had major surgery (including certain prostate procedures, but not prostate biopsy) within 28 days before the assignment date and have not fully recovered.
• People who have not fully recovered from a major surgery or who still have complications from surgery.
• People who have used herbal or medicinal products that may affect prostate cancer or PSA levels (such as saw palmetto, megesterol acetate, or citrus pectin polysaccharide) within 4 weeks before the assignment date.
• People who have received certain radioactive treatments (radium-223 or lutetium-177) within 4 weeks before the assignment date, or who have not recovered from their side effects.
• People who have used certain hormone-related medications (5-alpha reductase inhibitors such as finasteride or dutasteride, oestrogens, or cyproterone) within 4 weeks before the assignment date.
• People who have received colony-stimulating factor injections (used to boost white blood cells) within 28 days before the assignment date.
• People who have had a whole blood transfusion within the 120 days before the assignment date (packed red blood cells or platelet transfusions are acceptable if not given within 28 days before the assignment date).
• People who have received certain cancer-targeting drugs or hormone-blocking drugs too recently before the first study dose (specific waiting periods apply depending on the drug, ranging from 2 to 4 weeks).
• People whose bone scan shows a pattern called a "superscan" (confirm with trial site).
• People with an immune deficiency diagnosis, or who are currently taking steroid medication or other immune-suppressing drugs within 7 days before the first study dose.
• People who have another cancer that is currently active or has required treatment within the past 3 years.
• People with known active cancer spread to the brain or the lining around the brain or spinal cord.
• People with an active autoimmune disease that has needed systemic (whole-body) treatment within the past 2 years.
• People with an active infection that requires systemic treatment.
• People with a current active hepatitis B or known active hepatitis C infection.
• People with a history of a heart rhythm condition called long QTc syndrome.
• People with low blood pressure (systolic below 110 mmHg) or uncontrolled high blood pressure (systolic at or above 160 mmHg, or diastolic at or above 90 mmHg, recorded on 2 out of 3 readings despite medication) at the screening visit.
• People who are unable to swallow capsules or tablets.
• People currently taking certain anti-seizure medications that affect a liver enzyme called cytochrome P450.
• People who have been on an unstable dose of thyroid hormone medication within 6 months before the start of the study treatment.
• People who have received any other systemic cancer treatment, including experimental treatments, within 4 weeks before the first study dose.
• People who have received radiotherapy within 2 weeks before the start of the study treatment, or who still have side effects from radiation that require steroid treatment.
• People who have received a live or live-attenuated vaccine within 30 days before the first study dose.
• People who have taken certain medications that can interfere with how the study drugs work in the body within 2 weeks before the first study dose — this includes specific antibiotics, antifungals, HIV medications, heart medications, and herbal products such as St John's Wort or milk thistle (a full list of named drugs applies — confirm with trial site).
• People who have used certain medications called aldosterone antagonists (such as spironolactone or eplerenone) or the drug phenytoin within 4 weeks before the start of the study treatment.

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