"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
A trial of AZD3514 for prostate cancer that has spread and is no longer responding to hormone therapy
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new drug called AZD3514 for men who have prostate cancer that has spread to other parts of the body and is no longer responding to hormone therapy.
Doctors often use hormone therapy to treat prostate cancer. This may keep it under control for long periods of time. But researchers are looking for treatments that will help men who have prostate cancer that stops responding to hormone therapy.
In this trial, they are looking at a new drug called AZD3514. Prostate cancer needs the hormone
The aims of the trial are to
- Find the highest safe dose of AZD3514
- See if it slows the growth of prostate cancer that is no longer responding to hormone therapy
- Learn more about the side effects
- Find out more about AZD3514 and what happens to it in the body
- See if it is safe to have AZD3514 alongside a drug called abiraterone
Who can enter
You can enter this trial if you
- You have prostate cancer that has spread to other parts of your body
- Have cancer that PSA tests or scans show is getting worse and there is not another
standard treatmentthat your doctors think would be suitable for you
- Have a low level of the male hormone
testosterone(your doctor can advise you about this)
- Have satisfactory blood test results
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have recovered from the side effects of any other treatment (unless they are very mild), apart from hair loss or side effects from hormone therapy
- Are willing to use condoms during the trial and for a week afterwards if you are sexually active, and for 6 months afterwards if there is any chance your partner could become pregnant
- Are at least 20 years old
You cannot enter this trial if you
- Have cancer that is pressing on your spinal cord, or has spread to your brain, unless this has been treated, is not causing any symptoms and you have not needed steroids in the last 4 weeks
- Have had any other anti cancer treatment including immunotherapy or chemotherapy in the last 3 weeks (6 weeks if you had mitomycin C or one of a group of drugs called
nitrosoureas) - if you have been taking abiraterone, you may be able to take part
- Have had hormone therapy other than a drug that blocks LHRH such as Zoladex in the last 4 weeks (6 weeks if it was an anti androgen drug)
- Have had major surgery in the last 4 weeks
- Have had radiotherapy in the last 4 weeks, or radiotherapy for symptoms in the last 2 weeks
- Have already had AZD3514
- Have had another experimental drug as part of a clinical trial in the last month
- Have already had a drug that breaks down testosterone receptors
- Are known to be sensitive to AZD3154 or similar drugs
- Have taken drugs that affect an enzyme called CYP3A4 in the last 2 weeks
- Have sickness that cannot be controlled with medication or any other problem that would make it difficult for you to swallow or absorb the study drug
- Have high blood pressure that cannot be controlled with medication, or heart problems that are a cause for concern (the trial doctor can advise you about this)
- Have an infection or another serious medical condition
- Are known to be HIV, hepatitis B or hepatitis C positive
This is a phase 1 trial. It will recruit about 160 men in different countries around the world. Everybody taking part will have AZD3514 tablets. To begin with, you have a single dose of AZD3514. Then a week later, you start having it every day.
You take AZD3514 at about the same time each day. You take it once or twice a day and you must not eat or drink anything but water for 2 hours before taking it and for an hour afterwards.
The first patients taking part will have the lowest dose of AZD3514. If they don’t have any serious side effects, the next patients will have a higher dose. And so on, until they find the best dose to give. This is called a ‘dose escalation study’.
Some men joining the study will have AZD3514 alongside another drug called abiraterone. If they haven't had abiraterone before, they have AZD3514 on its own every day for a week, then they start taking abiraterone as well.
Some men joining the trial will have already had treatment with abiraterone, but tests show their cancer is now starting to get worse. These men continue to take abiraterone, but start taking AZD3514 as well. The researchers will ask these men to have 2 extra
When you take abiraterone, you also take a drug called prednisolone.
The length of time that you take the trial drug (or the combination of the trial drug, abiraterone and prednisolone), will depend on how much it helps you and whether or not you have any side effects.
As part of this trial, the researchers are looking for substances in the body that they can measure to help them tell how a disease is developing or how a treatment is working. These are called biomarkers. To find biomarkers, the trial team will ask your permission to take some extra blood samples. The trial team will also ask your permission to get a sample of cancer that was removed when you were originally diagnosed.
The researchers will ask to use 1 blood sample to study your genes to learn more about prostate cancer. If you don’t want to give these samples for research you don’t have to. You can still take part in the main trial.
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination
- Bone scan
- CT scan, MRI scan or X-ray
- Traces of your heart (
- Blood and urine tests
You go to hospital to have the first dose of AZD3514. You have a number of blood tests, urine tests and ECGs, so you will be at the hospital for at least 12 hours. You go back again on each of the next 4 days and have more blood tests and ECGs.
Over the next few weeks, you have a number of hospital visits. The trial team will give you more detailed information about the tests you will have and how long each visit will last. On some of the days that you go to hospital, you can’t eat or drink anything but water for 8 hours. The trial team will tell you which ones.
After the first couple of months, your hospital visits reduce to once every 4 weeks and continue like this for as long as you carry on having the trial treatment.
If you have AZD3514 and abiraterone, you go to hospital
- 6 times in the first month of treatment
- 3 times in the 2nd month
- Twice in the 3rd and 4th months
- Then once every 4 weeks
When you finish treatment, you see the doctors again and have some more tests.
As AZD3514 is a new treatment, there may be side effects we don’t know about yet. From tests in the laboratory, researchers know that the possible side effects include
- Feeling or being sick
- A drop in the number of blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Changes to the way your liver or kidneys work
- Increased levels of sugar in the blood
- Breathing difficulties or changes to how your lungs work
You must not east certain foods or take drugs that affect an enzyme called CYP3A4 during the trial and for 2 weeks before and after finishing the trial treatment, as they can affect how AZD3514 works.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr T. Elliott
Experimental Cancer Medicine Centre (ECMC)