
"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called AZD5363 alongside chemotherapy to see if it helps men with prostate cancer that has spread to another part of the body and isn’t responding to hormone therapy.
The trial is supported by Cancer Research UK.
If prostate cancer spreads to other parts of the body, doctors often treat it with hormone therapy. But after a while, this can stop working. If this happens, you may have chemotherapy and steroids. But researchers are looking for new treatments to help men in this situation. In this trial they are looking at a drug called AZD5363 alongside chemotherapy and steroids.
AZD5363 is a type of biological therapy. It stops signals that cancer cells use to divide and grow.
The aims of the trial are to
You may be able to enter this trial if you
You cannot enter this trial if you
This phase 1/2 trial will recruit about 150 men. The trial is in 2 parts.
In part 1, the researchers are looking for the highest dose of AZD5363 that you can safely have with docetaxel and prednisolone. In this part of the trial, everybody has AZD5363. The first few men taking part will have a low dose of AZD5363. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.
Please note - this part of the trial has finished and patients are now being recruited to part 2.
In part 2, they are comparing AZD5363 with a dummy drug (). This part of the trial is randomised. The men taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
Everybody joining this part of the trial has docetaxel and prednisolone. Half the men also have the highest safe dose of AZD5363 that was found in part 1. The other half will have a dummy drug.
In both parts of the trial you have chemotherapy in 3 week periods called cycles of treatment. You have up to 10 cycles of chemotherapy.
You have docetaxel through a drip into a vein on the 1st day of each treatment cycle. It takes about an hour each time. You take prednisolone tablets every day.
You take AZD5363 (or the dummy drug) throughout your treatment, starting on the 2nd day of the 1st cycle of chemotherapy. AZD5363 comes as tablets that you swallow. You take the tablets twice a day for 4 days, followed by a 3 day break.
You should take the tablets 12 hours apart and try to take them at about the same time each day. You mustn’t eat or drink anything apart from water for at least 2 hours before taking the tablets and for at least 1 hour afterwards.
If they are helping you, you can carry on taking the tablets after you finish having chemotherapy, as long as you don’t have bad side effects.
The trial team will give you a diary to help you to remember the days when you need to take the tablets.
They will also ask you to complete a questionnaire a number of times during the trial and when you finish treatment. It will ask about any pain you have, how it is being managed and how it is affecting your daily activities.
You see the trial team and have some tests before you start the trial treatment. The tests include
If you join phase 1 of the trial, you go to hospital 5 times in each of the first 2 cycles of treatment. You have a number of blood tests at these visits. On some days, the trial team will ask you not to eat anything for 8 hours before arriving at the hospital and not to take your capsules until you’ve had a blood test.
From cycle 3 onwards, you go to hospital at least once every 3 weeks for as long as you have the trial treatment.
If you join phase 2, you go to hospital twice in the 1st cycle of treatment and then once every 3 weeks after that.
Everybody has regular blood tests and some more heart traces throughout the trial. The trial team will explain what will happen at each hospital visit.
When you finish treatment, you see the trial team and have more blood tests and scans. You then continue to see them every 6 weeks until your cancer starts to get worse or you start another type of treatment.
As AZD5363 is a new drug, there may be side effects we don’t know about yet. In trials so far, the most common side effects have included
The most common side effects of docetaxel include
The most common side effects of prednisolone include
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Simon Crabb
AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University Hospital Southampton NHS Foundation Trust
This is Cancer Research UK trial number CRUK/12/042.
Freephone 0808 800 4040
"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”