Phase 4 Prostate Cancer Trial, Completed

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:

• You have been diagnosed with prostate cancer that has spread (metastatic) and confirmed by a tissue biopsy to be a specific type called adenocarcinoma.
• You are currently receiving hormone therapy to lower testosterone (using injections or implants called GnRH analogues) or have had both testicles surgically removed.
• Your cancer has gotten worse, shown by rising PSA blood test levels on at least 2 tests taken at least a week apart, new spots showing up on a bone scan, or growth of tumors seen on other scans.
• If you have not had your testicles removed, you must be willing to continue hormone therapy for the entire duration of the study.
• Your cancer has already stopped responding to at least one course of hormone therapy (GnRH analogue treatment).
• You are well enough to carry out some daily activities, though you may not be fully active (a standard doctor's rating scale score of 0–2).
• A neurologist (brain and nerve specialist) has assessed you before joining and found that you have at least one risk factor for seizures, such as: a past seizure (other than a single childhood fever-related seizure), a history of stroke or mini-stroke, a head injury with loss of consciousness, unexplained blackout in the last 12 months, a brain tumour or previously treated brain cancer, abnormal blood vessels in the brain, a past brain infection, currently taking medication that can lower the threshold for seizures, or a diagnosis of Alzheimer's disease or certain other brain conditions.
• You are able to swallow the study medication and follow all study requirements.
• You agree not to take part in any other treatment-based clinical trial while on this study.
• You and your female partner (if she could become pregnant) agree to use two forms of contraception — one of which must be a condom — from the start of the study until 3 months after the last dose of study drug.
• If your partner is pregnant, you must use a condom during sex.
• You must not donate sperm from the start of the study until at least 3 months after the last dose of study drug.

Who may not be able to join:

• You have previously been treated with a drug called enzalutamide.
• You have another serious illness, infection, or health condition that the study doctor feels would make it unsafe for you to participate.
• You are currently taking anti-epileptic (anti-seizure) medications.
• You have had a seizure within the 12 months before joining the study.
• Your cancer is spreading quickly to internal organs (such as the liver or lungs) and you have not yet tried chemotherapy, but doctors believe you could tolerate it (those who have already had chemotherapy may still be eligible).
• There are signs that you may be at high risk of a broken bone, spinal cord compression, or a related nerve problem in your lower back.
• Your blood test results at screening show that certain blood counts are too low — specifically, too few white blood cells, platelets, or red blood cells (confirm specific numbers with trial site).
• Your liver function blood tests are above acceptable levels, unless you have a specific known liver condition called Gilbert's disease (confirm with trial site).
• Your kidneys are not working well enough, based on a calculation using your blood creatinine level, age, and weight (confirm with trial site).
• Your blood pressure is too high and uncontrolled at the time of screening (systolic above 160 or diastolic above 100 mmHg).
• You have taken part in another clinical trial or received an experimental treatment within the past 4 weeks (or longer, depending on the drug) before the study starts.
• You have had an allergic reaction to enzalutamide or any of the ingredients in the study capsules, including Labrasol, butylated hydroxyanisole, or butylated hydroxytoluene.

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