Phase 3 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 who have signed a written consent form before any trial procedures begin.
• Men who have been confirmed through laboratory testing (biopsy or cell sample) to have prostate cancer of the adenocarcinoma type.
• Men who are 18 years of age or older at the time of signing the consent form.
• Men whose prostate cancer has already spread to other parts of the body (called metastatic disease) at the time of diagnosis, confirmed by clinical or imaging evidence. For men whose cancer has only spread to lymph nodes, specific size and location requirements apply (confirm with trial site).
• Men whose cancer can be measured or assessed on scans, or who have bone lesions that can be evaluated using specific prostate cancer guidelines.
• Men who are not suitable for treatment with any of the following drugs — docetaxel, abiraterone, enzalutamide, or apalutamide — AND who also meet at least one of the following signs of frailty: difficulty with daily living activities (based on a specific assessment score); difficulty with tasks like managing finances or transport (based on another specific assessment score); a significant health condition identified on a geriatric health questionnaire; a body mass index of 21 or below and/or more than 5% weight loss in the last 6 months; or taking longer than 14 seconds on a standard stand-and-walk mobility test.
• Men whose blood counts meet minimum levels — including haemoglobin, white blood cells, and platelets — as confirmed by blood tests.
• Men whose liver function blood test results are within acceptable ranges as defined by the trial.
• Men whose kidneys are functioning at or above a minimum level, as measured by a specific calculation from blood test results.
• Sexually active men who agree to use adequate contraception throughout the trial and for up to 2 weeks after finishing treatment.
• Men who are covered by a social security system or equivalent private health insurance, as required by local regulations.
• Men who are willing and able to follow the trial schedule, including attending appointments, receiving treatment, and completing follow-up visits.

Who may not be able to join:

• Men who have three or more significant health conditions, or any very severe health condition, identified on a specific geriatric health questionnaire (confirm with trial site).
• Men whose general physical functioning is severely limited, based on a standard performance scale used by doctors (a score of 3 or higher on the ECOG scale).
• Men with high blood pressure that is not adequately controlled by medication (consistently at or above 160/95 mmHg across three measurements taken 5 minutes apart).
• Men who still have significant side effects from previous treatments that have not returned to a mild level or to their pre-treatment baseline, with the exception of hot flushes and erectile dysfunction.
• Men who have previously received systemic treatment for prostate cancer, except for hormone therapy (ADT) or an older type of hormone-blocking drug taken for less than 12 weeks.
• Men with a serious or uncontrolled illness, infection, or other medical condition.
• Men with a known allergy or sensitivity to the study treatment or any of its components.
• Men who have had major surgery within 28 days before joining the trial.
• Men who have had a stroke, heart attack, severe or unstable chest pain, heart bypass surgery, or a serious level of heart failure within the 6 months before joining the trial.
• Men who have had another cancer within the last 3 years, with some exceptions — such as certain treated skin cancers, early-stage bladder cancers that have not spread deeply, localised cancers where treatment was completed at least 6 months ago with no signs of return and a low relapse risk, or early-stage chronic lymphocytic leukaemia not requiring treatment (confirm specific exceptions with trial site).
• Men who are unable to swallow oral medications.
• Men with a stomach or bowel condition or procedure that may significantly affect how the body absorbs the study treatment.
• Men with active hepatitis, active HIV, or chronic liver disease identified at the time of screening.
• Men who have taken part in another experimental drug trial within 28 days before joining.
• Men who are currently participating in another clinical trial that involves an experimental treatment.
• Men who are under legal guardianship or have had their personal liberty restricted.
• Men whose mental state, psychological situation, family circumstances, social situation, or location may prevent them from properly understanding or following the trial requirements, or who have any other condition that, in the treating doctor's opinion, would prevent safe participation.

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