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:

• Men aged 18 or older.
• People who have been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer) confirmed by a tissue sample, without certain rare features (neuroendocrine differentiation or small cell features).
• People who are willing and able to sign a written consent form before joining the study.
• People with a good general health and activity level, rated 0 or 1 on a standard scale used by doctors (meaning fully active or able to carry out light work).
• People willing to provide tumor tissue samples (biopsies) during the study — an archived biopsy taken after a specific stage of disease progression may be accepted in some cases, but a biopsy after treatment will still be required (confirm with trial site).
• People willing to provide blood samples for research purposes.
• People willing to allow testing of their DNA for changes in genes related to DNA repair.
• People with prostate cancer that has spread to other parts of the body (metastatic), confirmed by bone scan, CT scan, or MRI.
• People whose cancer is causing no symptoms or only mild symptoms at the time of screening.
• People with an estimated life expectancy of at least 6 months from the time of screening.
• People who are receiving ongoing hormone therapy (called androgen deprivation therapy) to lower testosterone, either through medication or prior surgical removal of the testicles.
• People whose cancer has progressed after receiving at least 12 weeks of treatment with abiraterone for hormone-sensitive metastatic prostate cancer, with progression defined either by a rising PSA level or limited spread to a small number of new areas on imaging.
• People who received prior docetaxel (a chemotherapy) only if they received no more than 6 cycles, and their last dose was more than 6 months before joining the trial.
• People with adequate blood counts, kidney function, liver function, and protein levels within 28 days before starting the study treatment (confirm specific values with trial site).
• People who are able to swallow tablets and follow all study requirements.
• People who agree to use a condom and an additional form of contraception when having sex with a woman who could become pregnant, or a condom when having sex with a woman who is pregnant, from screening until 3 months after the last dose of treatment (unless hormone therapy has made sexual activity impossible).
• People who agree not to donate sperm from screening until 3 months after the last dose of treatment.
• People who agree not to participate in another interventional clinical trial while on treatment.
• People willing and able to attend all scheduled visits, tests, and study procedures.

Who may not be able to join:

• People who received abiraterone for less than 12 weeks, or whose cancer progressed within 6 months of starting abiraterone.
• People whose cancer progressed within 6 months of their last dose of docetaxel for metastatic hormone-sensitive prostate cancer.
• People with known or suspected cancer spread to the brain or the lining around the brain and spinal cord.
• People whose bone scan at screening shows a pattern called a "superscan," which suggests very widespread bone involvement (confirm with trial site).
• People with symptoms of, or at risk of, spinal cord compression or a related condition called cauda equina syndrome.
• People using strong pain medication (opiates) for prostate cancer pain, with a high average pain score or with increasing opiate doses in the 4 weeks before joining the trial.
• People who have previously received other hormone-targeting treatments for prostate cancer (such as enzalutamide, apalutamide, darolutamide, or ketoconazole), or chemotherapy other than up to 6 cycles of docetaxel, or immunotherapy, or radioactive drug treatments.
• People who have had radiation therapy within 14 days before joining (or 7 days for limited palliative radiotherapy), or who have not recovered from radiation side effects.
• People who have had major surgery within 4 weeks before joining, or who have not fully recovered from surgery.
• People who have received an experimental treatment or had an invasive surgical procedure (not including surgical castration) within 30 days of starting the study, or who are currently in another interventional study.
• People with a history of seizures, certain brain injuries or abnormalities, unexplained loss of consciousness, or a mini-stroke within the past year.
• People with a heart condition called congenital long QT syndrome, or an abnormal heart reading (ECG) at screening showing a specific measurement above a safe threshold.
• People with significant heart or blood vessel conditions, including stroke, mini-stroke, unstable chest pain, or heart attack in the past 12 months; inflammation around the heart; moderate to severe heart failure; or blood pressure that is not well controlled.
• People with certain abnormal heart rhythm conditions that require a pacemaker or cannot be controlled with medication.
• People with significant digestive conditions that affect how the body absorbs medication (such as major bowel surgery or active inflammatory bowel disease).
• People with active or symptomatic viral hepatitis or chronic liver disease.
• People with a known or possible allergy or sensitivity to enzalutamide, talazoparib, or any ingredients in the study capsules.
• People with another current cancer, except for non-melanoma skin cancer, carcinoma in situ, or a cancer that was diagnosed and fully treated at least 5 years ago with no signs of return.
• People with any other condition that, in the treating doctor's judgment, could put them at risk, affect study results, or interfere with participation.

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