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 willing and able to give written consent before any screening takes place (or have a legal representative do so on their behalf).
• People who are 18 years of age or older.
• People who are willing to be assigned to either treatment group and follow the study rules.
• People who are able to swallow capsules and/or tablets whole.
• People who are willing to stay on the study treatment and continue having scans even if PSA levels rise, unless their health is clearly getting worse.
• People who have a confirmed diagnosis of prostate adenocarcinoma (a specific type of prostate cancer), without certain features called neuroendocrine differentiation or small cell features.
• People whose cancer (in a tumour sample or blood test) shows a specific type of gene change — called a pathogenic homologous recombination repair (HRR) mutation — in at least one of these genes: BRCA1, BRCA2, ATM (limited to 15% of participants), CDK12, CHEK2, PALB2, MLH1, NBN, ATR, FANCA, MRE11A, RAD51C, tested through an approved laboratory.
• People with prostate cancer that has spread to other parts of the body and is no longer responding to hormone-lowering treatment (known as metastatic castration-resistant prostate cancer, or mCRPC), confirmed by approved imaging methods.
• People whose cancer previously progressed while receiving a specific hormone therapy called abiraterone acetate with prednisone, used for either locally advanced disease or hormone-sensitive metastatic prostate cancer.
• People whose cancer is currently progressing despite having very low testosterone levels (below 50 ng/dL), either through surgical removal of the testicles or ongoing hormone-blocking medication.
• People whose disease progression is shown by at least one of: rising PSA levels, growth of soft tissue tumours on scans, two or more new bone lesions on a bone scan, or new lesions identified on a PSMA PET scan.
• People with a general health and activity level rated at 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity) (confirm with trial site).
• People whose blood test results within 14 days before starting treatment fall within acceptable ranges for blood cell counts, kidney function, liver function, and potassium levels (confirm with trial site for specific values).
• People who agree to use an effective method of contraception during the study and for four months after the last dose, and to avoid sperm donation during this time. Female partners must also use hormonal or barrier contraception unless they are post-menopausal or abstinent.

Who may not be able to join:

• People who have another active cancer at the time of starting the study, or who have been diagnosed with another cancer requiring active treatment within the past three years (except certain easily curable skin cancers or superficial bladder cancer).
• People who have previously been treated for castration-resistant prostate cancer (CRPC) with a different type of hormone therapy drug — other than abiraterone acetate with prednisone — for 12 weeks or more.
• People who received chemotherapy for hormone-sensitive prostate cancer less than six months before the start of the study.
• People who have used an investigational (experimental) prostate cancer treatment within four weeks before starting the study.
• People who have previously been treated with a type of drug called a PARP inhibitor.
• People currently being treated with a drug called crizotinib.
• People who have previously received platinum-based chemotherapy for prostate cancer.
• People currently using, or planning to use, certain medications known as strong P-gp inhibitors within seven days before joining the study — a specific list of these medications is outlined in the trial criteria (confirm with trial site).
• People currently using certain other medications that affect how drugs are processed by the liver (including strong CYP2C8 inhibitors or inducers, strong or moderate CYP3A4 inducers, or certain other enzyme-sensitive drugs), unless medically necessary for a life-threatening condition (confirm with trial site for the full list).
• People who have used certain hormone-related medications that act against prostate cancer — such as testosterone, certain anti-androgens, or estrogens — within 28 days before starting the study.
• People who have used certain herbal products or supplements that may lower PSA or have hormone-like effects on prostate cancer (such as saw palmetto or St. John's Wort) within 28 days before starting, or who plan to use them during the study.
• People who have received a blood transfusion within 14 days before being assigned to a treatment group.
• People with a history of seizures, certain brain injuries or strokes, loss of consciousness, or a mini-stroke (transient ischemic attack) within the past 12 months.
• People with uncontrolled high blood pressure, uncontrolled diabetes, or heart conditions that the investigating doctor considers would make participation unsafe.
• People with untreated cancer that has spread to the brain or spinal cord, or significant cancer affecting the tissue around the spine.
• People currently using any other prohibited medications listed in the trial's drug interaction guidelines within 28 days before starting the study (confirm with trial site).
• People who still have significant side effects (rated above grade 2) from a previous cancer treatment, except for hair loss or nerve-related symptoms in the hands or feet.
• People who have a known allergy to any of the medications being studied.
• People whom the trial investigator considers unable to safely participate for any other reason.

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