A trial looking at enzalutamide and Ra223 for men with prostate cancer (PEACE III)

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

• You have adenocarcinoma of the prostate (prostate cancer) that has spread to the bones
• You have 4 or more areas of cancer in the bones and this has been confirmed by a CT scan or MRI scan
• You take medicines to prevent fractures and strengthen the bones
• Your cancer is causing no pain or only mild pain (and you aren’t taking strong painkillers such as opioids)
• Your PSA level and scans show that your cancer is getting worse
• You take drugs to lower the levels of the male hormone testosterone such as Zoladex or have had both your testicles removed (orchidectomy)
• You have very low levels of testosterone (less than 50 ng/dL)
• You have satisfactory blood tests results
• Your heart is working well
• You are able to swallow and absorb tablets
• You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
• You are at least 18 years old
• You are willing to use reliable contraception during treatment and for 3 months after the final dose of enzalutamide or for 6 months after the last dose of Ra223 if there is any possibility your partner could become pregnant.

You cannot join this trial if any of these apply.

• Your cancer has spread to internal organs (such as lungs and liver), the brain, spinal cord or the tissues that surround the brain (carcinomatous meningitis)
• You have had another cancer in the past 3 years apart from basal cell skin cancer, squamous cell skin cancer or an early cancer (carcinoma in situ) of the bladder that has been successfully treated
• You have had a type of external radiotherapy to help with pain from cancer that has spread to the bones (hemibody radiotherapy). You may be able to take part if you had any other type of external radiotherapy and you don’t have side effects from it
• You have had treatment with enzalutamide, Ra223 or with any other radioactive drugs (such as strontium-89)
• You have had docetaxel or abiraterone for castration resistant prostate cancer
• You have had drugs that affect certain proteins called cyp17 (such as abiraterone), drugs to treat fungal infections (such as ketoconazole) or drugs that affect your heart (such as clarithromycin and chlorpromazine)
• You have had drugs that block the effect of testosterone (such as bicalutamide or flutamide) is the past 48 hours
• You take a high dose of corticosteroids such as prednisolone  
• You have had an experimental drug as part of a clinical trial in the past 4 weeks
• You have osteonecrosis of the jaw
• You have had a major surgery in the past 4 weeks
• You have had a fit (seizure), loss of consciousness, a transient ischemic attack (TIA) or any other condition that makes you at risk of having a fit (such as stroke or head trauma) in the past 12 months
• You have had heart problems such as congestive heart failure, high or low blood pressure and problems with your heart rhythm (arrhythmias and bradycardia) that are not controlled by medication, a heart attack in the past 6 months, angina that is not controlled in the past 3 months or you have a pacemaker
• You have a serious medical condition such as an infection that needs antibiotics, inflammation of the bowel (ulcerative colitis or Crohn’s disease), problems with your bone marrow, a condition that affects the way you absorb tablets (such as active peptic ulcer) or you have a problem controlling your bowels (faecal incontinence) 
• You are known to be sensitive to enzalutamide, Ra223 or anything they contain
• You have any other serious medical condition or mental health problem that the trial team think could affect you taking part
• You take drugs or drink an amount of alcohol that is a concern for your doctors