Phase 3 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:

• Adults (as defined by local law at the time of signing consent) may be considered.
• People who have been diagnosed with a specific type of prostate cancer confirmed by laboratory testing of tissue or cell samples — specifically adenocarcinoma, but not certain rare subtypes (neuroendocrine, signet cell, or small cell types).
• People whose prostate cancer has spread to bones (shown on a bone scan) or to other soft tissues (shown on a CT or MRI scan) — but not those whose cancer has spread only to nearby pelvic lymph nodes.
• People who are receiving or willing to maintain hormone-suppressing therapy (LHRH agonist or antagonist) throughout the study, or who have previously had surgical removal of both testicles.
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity) (confirm with trial site).

For the open-label extension phase of the trial, additional criteria apply:

• People who completed the randomised, double-blind part of the ARCHES trial without meeting any stopping criteria.
• People willing to continue hormone-suppressing therapy or who have had both testicles surgically removed.
• People able to swallow the study capsules whole and follow all study requirements.
• People (and their female partners) who agree to follow the contraception and sperm donation rules set out in the main study protocol.

Who may not be able to join:

• People who have previously received drug treatment, radiation, or surgery for metastatic (spread) prostate cancer — though some specific limited prior treatments may be permitted, including:
  • Up to 3 months of hormone-suppressing therapy (with or without anti-androgen tablets) before day 1, provided there is no sign of disease worsening beforehand.
  • A single course of palliative (symptom-relieving) radiation or surgery, if completed at least 4 weeks before day 1.
  • Up to 6 cycles of docetaxel chemotherapy, completed within 2 months of day 1, with no sign of disease worsening during or after treatment.
  • Up to 6 months of hormone-suppressing therapy if docetaxel was also given, with no sign of disease worsening beforehand.
  • Prior hormone therapy lasting less than 39 months total and finishing more than 9 months before joining, given as preventive treatment around the time of initial cancer treatment.
• People who have had major surgery within 4 weeks before day 1.
• People who have taken certain prostate-related medications called 5-alpha reductase inhibitors (such as finasteride or dutasteride) within 4 weeks before day 1.
• People who have been treated with oestrogens, cyproterone acetate, or androgens within 4 weeks before day 1.
• People who have taken high-dose steroid medications (above the equivalent of 10 mg per day of prednisone) to treat prostate cancer within 4 weeks before day 1.
• People who have used herbal medicines known to have anti-prostate cancer effects or known to lower PSA levels within 4 weeks before day 1.
• People who have previously been treated with specific hormone-blocking drugs including aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide, or who have taken part in a clinical trial of similar investigational drugs (confirm with trial site).
• People with known or suspected cancer spread to the brain or the lining around the brain or spinal cord.
• People with certain abnormal blood test results, including low white blood cell counts, low platelet counts, or low haemoglobin (anaemia) (confirm specific thresholds with trial site).
• People with certain abnormal liver function blood test results (confirm specific thresholds with trial site), except those with a known condition called Gilbert's disease (confirm with trial site).
• People with a kidney function blood test result above a certain level (confirm with trial site).
• People with low blood protein (albumin) levels below a certain threshold (confirm with trial site).
• People with a history of seizures (fits) or any condition that may increase the risk of seizures.
• People who have had a loss of consciousness or a mini-stroke (TIA) within 12 months before day 1.
• People with serious heart or blood vessel disease.
• People who have recently started bone-strengthening medications (bisphosphonates or denosumab) within 2 weeks before day 1, unless the dose has been stable or the medication is being taken for diagnosed osteoporosis.

For the open-label extension phase, additional exclusion criteria apply:

• People who have already taken commercially available enzalutamide (Xtandi) outside of this trial.
• People whose cancer worsened (on imaging) during the double-blind phase and who stopped taking the study drug before the study results were revealed — though those who continued the study drug despite imaging progression may still be eligible (confirm with trial site).
• People who have started any new experimental or anti-cancer treatment for prostate cancer after the study results were revealed.
• People with significant health conditions — including serious alcohol or drug misuse, or a second cancer — that could interfere with participation.
• People with current or previously treated cancer spread to the brain or its surrounding lining.
• People with a history of seizures or any condition that may increase the risk of seizures.

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