A trial looking at AZD5363 and enzalutamide for advanced prostate cancer (RE-AKT)

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

• You have adenocarcinoma of the prostate gland that has spread to other parts of your body (metastatic prostate cancer) and it is continuing to grow despite having treatment
•  Your diagnosis was confirmed when you had surgery, or when a sample (biopsy) of your cancer was taken. If this is not the case, you will need to have a biopsy to confirm your diagnosis
• A sample of your cancer is available for the trial team to test for a fault in a gene called PTEN
• You have had hormone therapy with the aim of lowering the amount of testosterone in your body
• You have had at least 1 or 2 treatments with a group of chemotherapy drugs called taxanes
• You have had treatment with a drug called abiraterone (you must have had this treatment for at least 3 months)
• Have a PSA blood test result that is equal to or more than 10ng/ml
• Have satisfactory results from other blood tests
• Are well enough to be up and about for at least half of the day (performance status 0,1 and 2)
• You are willing to use contraception during the trial and for at least 1 year afterwards if you are sexually active and there is any chance 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 your brain
• Have already had treatment with drugs that block the action of cancer growth blockers such as P13K inhibitors, AKT inhibitors or mTOR inhibitors (your doctor can advise you about this)
• Have had surgery, chemotherapy, or treatment in a trial in the last 4 weeks
• Have had hormone therapy in the last 2 weeks, or in the last 6 weeks if you had a drug called bicalutamide (Casodex)
• Have had radiotherapy in the last 4 weeks (you can take part if you have had radiotherapy to just a small area of your body to control symptoms in the last 2 weeks)
• Have had any other anti cancer treatment in the last 4 weeks (there are some drugs that you can’t have taken in the last 2 weeks, the trial team can advise you about this)
• Have had any other cancer in the last 5 years apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
• Are still having side effects from any anti cancer treatment, apart from hair loss or severe numbness and tingling in your hands and feet (peripheral neuropathy 
• Have had fits (seizures) in the past, or you have a medical condition or injury which puts you at risk of having a fit (your doctor can confirm whether this applies to you)
• Have been diagnosed with diabetes or have high levels of sugar in your blood (you will have a blood test to check this)
• Have a condition which means your body cannot absorb the trial drug properly
• Have any other medical condition that the trial doctor thinks could affect your taking part
• Have had any medication that affects body substances called CYP enzymes in the last 2 weeks (with the exception of St John’s wort, which you should avoid for 3 weeks before the start of the trial). Your doctor can explain what this means in more detail
• Have certain heart problems such as a heart attack in the last 6 months or heart failure
• Have certain liver problems, such as cirrhosis of the liver or hepatitis
• Are unable to swallow tablets

As well as the above, men who join part 2 of the trial cannot take part if they have already had treatment with enzalutamide.