Phase 3 Prostate Cancer Trial, Completed

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 who have been diagnosed with prostate cancer (a specific type called adenocarcinoma, confirmed by lab testing of a tissue or cell sample)
• People whose prostate cancer continued to grow or spread while receiving hormone-blocking treatment (or after surgical removal of both testicles), within 6 months before the screening visit
• People who have evidence that their cancer has spread to bones (seen on a bone scan) and/or to other soft tissues (seen on a CT or MRI scan)
• People who have previously been treated with either abiraterone acetate OR enzalutamide — but not both — and whose cancer progressed during or after that treatment (for at least 8 weeks on treatment, or at least 14 weeks if the cancer spread involved bones)
• People who received abiraterone acetate for hormone-sensitive metastatic prostate cancer but did not go on to receive abiraterone acetate or enzalutamide after the cancer became castration-resistant
• People who have previously received docetaxel chemotherapy for castration-resistant prostate cancer, and whose cancer continued to grow during or after that treatment
• People whose testosterone levels remain very low (below 50 ng/dL) due to ongoing hormone-blocking treatment
• People who, if currently taking bone-strengthening medications (such as bisphosphonates or denosumab), have been on a stable dose before joining the trial
• People who agree to avoid donating sperm during the trial and for a set period after the last dose, and who either abstain from heterosexual intercourse or agree to use contraception (or are confirmed to have no sperm in their semen) — in line with local regulations
• People who can provide a tumour tissue sample from a recent biopsy (taken within 12 months of screening) from soft tissue that has not been previously treated with radiation (or from a bone biopsy if the cancer is primarily in the bones)
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or restricted only in physically strenuous activity), assessed within 7 days of joining

Who may not be able to join:

• People who have another cancer that is currently growing or has needed active treatment in the past 3 years
• People who have an active autoimmune disease (where the immune system attacks the body) that has needed systemic medical treatment in the past 2 years
• People who have a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis
• People with a known active HIV, hepatitis B, or hepatitis C infection
• People with known active cancer spread to the brain or the lining of the brain or spinal cord
• People who have a history of seizures or any condition that could increase the risk of seizures
• People who have lost consciousness at any point within 12 months before screening
• People who have, or show signs of having, a blood disorder called myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML)
• People who have been diagnosed with an immune deficiency condition, or who are currently taking long-term steroid medication throughout their body
• People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients
• People with a known allergy to the ingredients in olaparib, abiraterone acetate, prednisone, prednisolone, or enzalutamide
• People who have significant heart failure symptoms (classified as Class III or IV by a standard heart disease rating system)
• People who have previously received a certain type of cancer-fighting drug called a monoclonal antibody before joining the trial
• People who have previously been treated with olaparib or any other PARP inhibitor drug
• People who have previously been treated with apalutamide or darolutamide
• People who have previously received enzalutamide or apalutamide for hormone-sensitive metastatic prostate cancer
• People who have used herbal products known to have anti-prostate cancer effects or to lower PSA levels (such as saw palmetto) before joining the trial
• People who have previously received radium or other radioactive treatments for prostate cancer
• People who have previously received certain immunotherapy drugs, including anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or similar immune checkpoint treatments (such as those targeting CTLA-4, OX-40, or CD137)
• People who are currently taking certain medications that strongly or moderately affect how the body processes some drugs (specifically CYP3A4 inhibitors) and cannot stop taking them for the duration of the study
• People who have previously had a bone marrow transplant from a donor, a double umbilical cord transplant, or a solid organ transplant
• People who have received a live vaccine within 30 days before joining the trial
• People who are currently taking part in, or have taken part in, another clinical trial of an experimental treatment within 4 weeks before joining
• People whose bone scan shows a particular pattern called a "superscan" (confirm with trial site)
• People who are planning to father children from the screening visit through to 90 days after the last dose of the study treatment

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