Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from the 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 aged between 18 and 80 years old.
• People who have been diagnosed with prostate cancer (a specific type called adenocarcinoma) that has spread to other parts of the body, confirmed by a tissue or cell sample, and detected by bone scan, CT, or MRI.
• People who have had, or are able to have, a biopsy of a cancer lesion before starting the trial — or who have biopsy tissue collected within 30 days before joining.
• People whose cancer has stopped responding to at least one of the newer hormone-blocking treatments, such as abiraterone, enzalutamide, apalutamide, darolutamide, or rezivilutamide.
• People who have previously been treated with the chemotherapy drug docetaxel, or who have documented reasons why they could not tolerate or chose not to have chemotherapy.
• People whose cancer is showing signs of getting worse, either through rising PSA levels (a prostate cancer marker in the blood), new or growing tumours on scans, or new bone lesions detected on a bone scan.
• People who are receiving ongoing hormone-suppressing injections (to keep testosterone very low) or who have had both testicles surgically removed, with testosterone blood levels confirmed to be at castrate levels.
• People whose general physical health and ability to carry out daily activities falls within an acceptable range on a standard medical scale (ECOG score of 0 to 2, meaning fully active to capable of limited self-care — confirm with trial site).
• People with a life expectancy of at least 6 months.
• People whose blood counts (white cells, red cells, platelets, and infection-fighting cells) are within acceptable ranges as measured by blood tests.
• People whose liver function blood test results are within acceptable limits (with slightly higher limits allowed if cancer has spread to the liver).
• People whose blood clotting function is within acceptable ranges on standard tests.
• People whose heart is pumping effectively (at least 50% efficiency), whose heart rhythm measurement (QTc) is below 450 ms, and whose blood potassium level is within a normal range.
• People whose blood pressure is below 160/95 mmHg, including those whose blood pressure is controlled with appropriate management.
• People whose kidney function blood test results are within acceptable limits.
• People who are sexually active with the ability to produce sperm and who agree to use effective contraception and avoid sperm donation from the first dose until 3 months after the last dose of study treatment.
• People who are able to understand the study information and are willing to sign a consent form.
• People who are able to attend study visits and follow the study requirements.

Who may not be able to join:

• People who are planning to receive any other cancer treatment at the same time as the trial treatment.
• People who have cancer that has spread to the brain.
• People who have previously been treated with immunotherapy drugs, including checkpoint inhibitors (such as PD-1, PD-L1, or CTLA-4 inhibitors), or any cancer treatment that works by activating the immune system.
• People who have had another cancer in the past 3 years that is still active or requires treatment — with some exceptions for certain skin cancers or early-stage cancers that have been treated with curative intent.
• People who have an active autoimmune disease or active infection (including tuberculosis) that has required systemic medical treatment within the past 2 years (hormone replacement therapies for common conditions are not counted as systemic treatment).
• People who have a condition affecting the immune system, or who have been taking steroid medication above a certain dose (more than 10 mg of prednisone or equivalent per day) or other immune-suppressing medications within 14 days before the first dose.
• People who have a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have non-infectious lung inflammation.
• People who have received radiation therapy or certain radioactive treatments (such as Radium-223) within 28 days before the first dose, or who have taken abiraterone within 1 week, or other hormone-blocking treatments within 2 weeks before the first dose.
• People who have had a severe allergic reaction or intolerance to the type of medication being studied (a PD-L1 monoclonal antibody) or any of its ingredients.
• People with a known history of significant neurological or psychiatric conditions such as dementia, epilepsy, or conditions that increase the risk of seizures.
• People with other serious ongoing medical or psychiatric conditions — such as severe diabetes, thyroid disease, or mental health conditions — that in the treating doctor's judgement could put the person at risk or make it difficult to complete the study.
• People who, for any other reason, the trial doctor considers unsuitable for participation.

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