A trial of enzalutamide for prostate cancer that has a high risk of coming back (ENZARAD)

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

You might be able to join this trial if all of the following apply. 

• You have adenocarcinoma of the prostate that has a high risk of coming back. This means one of the following applies. You have
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  • a gleason score of 8 to 10
  • a gleason score of 4+3, the cancer is contained within the prostate gland or has grown into surrounding tissue (stage T2b to stage T4) and you have a PSA blood test result of more than 20
  • cancer cells in nearby lymph nodes in the lower pelvis (the area between your hip bones) (stage N1)​
     
• Your treatment is planned and you are able to start within 7 days of being put into a treatment group
• You completed the quality of life questionnaire before starting treatment unless you have limited vision or you have reading difficulties
• You have satisfactory blood test results
• You are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
• You are willing to use reliable contraception during the trial if there is any chance that your partner could become pregnant 
• You are at least 18 years old

You cannot join this trial if any of these apply. You:

• Have cancer that has spread to another part of the body
• Have a large number of cells called sarcomatoid, spindle cell or neuroendocrine small cells in your tissue sample (biopsy )  
• Have cancer cells in the lymph nodes in the upper part of the pelvis or outside the pelvis 
• Can’t have external beam radiotherapy for any reason 
• Have a PSA blood test result that is more than 100
• Are having hormone therapy including a type called an anti androgen such as flutamide or enzalutamide. You might be able to take part if you have had a type of hormone therapy called a luteinising hormone blocker such as goserelin for less than 30 days before joining this trial.
• Have had surgery to remove both testicles (an orchidectomy) or you have had surgery to remove the prostate gland
• Have had internal radiotherapy (brachytherapy ) or external radiotherapy that would result in the area where you due to have radiotherapy overlapping
• Have had major surgery in the last 21 days
• Have had any other treatment as part of a clinical trial
• Have had any other cancer in the last 5 years apart from non melanoma skin cancer or very early bladder cancer that was successfully treated
• Have HIV unless it is well controlled with medication that won’t be affected by enzalutamide
• Have any condition that means you could have fits (seizures) or you have experienced seizures in the past
• Have blacked out or had a mini stroke (TIA) in the last year
• Have had a serious heart problem in the last 3 months such as a heart attack, an abnormal heart rhythm, a stroke or a condition called atrial fibrillation unless you are taking medicine to prevent clotting 
• Have a severe infection that needs treatment
• Have a problem with your digestive system that would affect how the trial drug is absorbed
• Have a problem with swallowing tablets
• Have a problem with drugs and alcohol
• Have any other serious medical condition or mental health problem that the study team think could affect you taking part