Phase 3 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 have signed a written informed consent form before any trial procedures begin (if someone is physically unable to sign, a trusted person of their choice may confirm consent in writing on their behalf)
• People aged 18 years or older
• People who have been diagnosed with a specific type of prostate cancer (adenocarcinoma) confirmed by a tissue sample, without certain rare features (small cell or pure endocrine)
• People who have previously had treatment aimed at curing localised prostate cancer, such as surgery or radiotherapy
• People whose prostate cancer has continued to grow or spread despite hormone-lowering therapy (castration-resistant prostate cancer), shown by rising PSA levels on three separate tests, tumour growth on scans, or new spots on a bone scan
• People who have between 1 and 5 areas of cancer spread (metastases), detected on a specialised PET scan using choline, fluciclovine, or PSMA tracers
• People whose metastatic sites are all suitable for a precise type of targeted radiation treatment called stereotactic radiation therapy
• People whose blood counts fall within acceptable ranges (sufficient neutrophils, platelets, and haemoglobin levels)
• People whose liver function test results are within acceptable limits
• People whose liver protein and waste-filtering levels are within acceptable ranges
• People whose blood pressure is below 160/100 mmHg at the start of the trial (people with controlled high blood pressure may still be eligible)
• People whose kidneys are functioning adequately, based on a standard calculation of kidney filtering ability
• People who are generally well enough to carry out daily activities with no more than minor limitations, based on a standard medical fitness scale (ECOG performance status of 0 or 1)
• People who are willing to use contraception during treatment and for at least one week after stopping the study medication (darolutamide)
• People who are enrolled in a social security system or local equivalent, as required by regulations
• People who are willing and able to attend all required appointments, treatments, and follow-up visits for the full duration of the trial

Who may not be able to join:

• People who have previously received certain advanced treatments for metastatic prostate cancer, including newer hormone therapies, CYP17 inhibitors, ketoconazole, chemotherapy, or immunotherapy
• People who have had another cancer within the past 3 years, with the exception of certain fully treated localised cancers such as non-melanoma skin cancer or early-stage bladder cancer
• People who have an uncontrolled medical condition that the trial doctor believes would interfere with participation or require hospitalisation
• People who have active hepatitis or active HIV infection at the time of screening
• People who have a known allergy or serious reaction to the study drug or any of its ingredients
• People who are unable to swallow tablets or oral medications
• People who have a stomach or bowel condition or have had a procedure that could significantly affect how the body absorbs the study drug
• People who have experienced a stroke, heart attack, severe unstable chest pain, bypass surgery, or serious heart failure (NYHA Class III or IV) within the 6 months before joining the trial
• People who are currently participating in another treatment trial, or who have done so within the 30 days before being assigned to a treatment group
• People who are unable to meet trial requirements for geographic, social, or physical reasons, or who are unable to understand the trial's purpose and procedures
• People who are under legal custody, protective supervision, or guardianship

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