Phase 2 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 are 18 years of age or older, of any race or ethnic background
• People who have signed a consent form agreeing to take part and follow the study requirements
• People who have been confirmed through a tissue test (biopsy) to have prostate cancer that has not spread to other parts of the body
• People whose prostate cancer falls into a high-risk category based on at least one of the following: a cancer aggressiveness score (called Gleason sum) above 7, a tumour stage classified as T3 that can be surgically removed, or a PSA blood test result above 20 ng/ml
• People whose cancer risk is assessed using a specific online tool (the Memorial Sloan Kettering nomogram) showing a 50% or lower chance of remaining cancer-free 5 years after surgery — this applies in certain situations where only one high-risk feature is present (confirm with trial site)
• People whose bone scan shows no clear signs that the cancer has spread to bones
• People whose pelvic CT scan (if required) shows no lymph nodes larger than 2 cm
• People who have decided, after discussion with their doctor about other options including radiotherapy, to have surgical removal of the prostate (prostatectomy) with extended lymph node removal as their primary treatment
• People able to provide a tumour tissue sample from a biopsy taken within the past 6 months, or in some cases an older stored sample (with sponsor agreement)
• People whose tumour tissue shows a specific marker result (PTEN staining of 10% or less) as measured by the central laboratory
• People who are in good general health, rated 0 or 1 on a standard health scale (ECOG), with no decline in the 2 weeks before starting the study
• People whose treating doctor estimates their life expectancy to be greater than 10 years
• People who weigh at least 45 kg and have a Body Mass Index (BMI) of at least 18.5
• People who are able to swallow and keep down oral (tablet/capsule) medication
• People whose blood test results show the heart, liver, kidneys, and blood cells are working well enough, as measured within 30 days before treatment starts
• Men who are not surgically sterile and may be sexually active with a partner who could become pregnant must use a condom from the start of the study until 16 weeks after the last dose of the study drug; contraception for female partners should also be considered

Who may not be able to join:

• People with serious or poorly controlled health conditions such as uncontrolled high blood pressure, active bleeding conditions, severe lung, kidney, or liver problems, uncontrolled infections, or significant heart disease
• People with any other condition that, in the doctor's opinion, makes participation unsafe or could affect the study results
• People with active hepatitis infection, a positive hepatitis C antibody, hepatitis B surface antigen, or hepatitis B core antibody
• People with HIV who have a low immune cell count (CD4+ below 350 cells/uL) or who have had a serious HIV-related infection in the past 12 months
• People with active tuberculosis
• People with a known history of drug or alcohol misuse within 6 months before screening
• People who have already had any prior treatment for prostate cancer, including hormone therapy, surgery to remove the testes, radiation therapy, chemotherapy, or any experimental treatment (note: short-term hormone therapy of 2 months or less may be allowed — confirm with trial site)
• People who have had another cancer in the past 5 years, except for certain low-risk skin cancers or cancers treated with curative intent that are considered very unlikely to return
• People with certain heart problems, including an abnormal heart rhythm reading on an ECG, a history of significant heart rhythm disorders, heart failure, a heart attack or blood clot event in the past 6 months, certain heart procedures in the past 6 months, very low or very high blood pressure, or a reduced heart pumping function below 50%
• People with type 1 or type 2 diabetes who require insulin, or whose long-term blood sugar measurement (HbA1c) is 8.0% or higher
• People who have ongoing nausea or vomiting, significant bowel or digestive conditions, or have had major bowel surgery that could prevent the study medications from being absorbed properly
• People with known psychiatric conditions or substance use problems that would make it difficult to follow the study requirements
• People who have previously had a bone marrow transplant from a donor or a solid organ transplant
• People who have had major surgery within 6 weeks before screening, or a significant injury within 4 weeks of the first study dose (prostatectomy is an exception)
• People currently taking part in another clinical trial or who have received an experimental treatment within 30 days (or 5 half-lives of the drug, whichever is longer) before starting this study
• People who have received certain cancer-fighting antibody treatments within 30 days before the study starts, or who are still experiencing side effects from such treatments
• People who have received chemotherapy, immunotherapy, targeted drug therapy, immune-suppressing medicines, or radiation therapy within 30 days before the study starts, or who are still experiencing side effects (minor nerve-related side effects may be an exception — confirm with trial site)
• People who have recently taken certain specific medications that could interfere with the study drugs, including drugs that affect how the body processes the study medication, drugs that affect heart rhythm, or drugs that interact with one of the study treatments (abiraterone)
• People with a known allergy or sensitivity to the study drugs (capivasertib or abiraterone) or similar medicines
• People for whom the prescribing guidelines for abiraterone or leuprolide (another study medication) would prevent their use
• People who are unable to have a research biopsy, which is required as part of the study
• People who, in the doctor's judgement, are unlikely to follow the study procedures and requirements

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