"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 custirsen with docetaxel and prednisolone for prostate cancer that has spread and is not 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 drug called custirsen (also known as OGX-011) alongside chemotherapy for prostate cancer that has spread to other parts of the body and is not responding to hormone therapy.
Doctors can treat prostate cancer with hormone therapy. But if the cancer doesn’t respond to this type of treatment, or hormone therapy is no longer controlling the cancer, you may have chemotherapy. Doctors often use a chemotherapy drug called docetaxel. You may have docetaxel with a steroid drug called prednisolone.
Some cancer cells produce a lot of a protein called clusterin. This may help them to protect themselves from cancer drugs and stop the drugs working as well as they could.
In this trial, researchers are looking at a drug called custirsen, which can reduce the level of clusterin. Researchers hope that by lowering the levels of clusterin, the cancer drugs will work better.
The aim of the trial is to see if adding custirsen to docetaxel and prednisolone improves this treatment for men with prostate cancer that has spread and is not responding to hormone therapy.
Who can enter
You may be able to enter this trial if you
- Have prostate cancer that has spread outside your prostate gland, is now in your bones, lungs or tummy (abdomen) and is not responding to hormone therapy
- Are willing to use reliable contraception during the trial if there is any chance your partner could become pregnant
You cannot enter this trial if you
- Have cancer that has spread to your brain
- Have cancer that is pressing on your spinal cord (spinal cord compression) and this needs treating with surgery or radiotherapy
- Have already had any type of chemotherapy for prostate cancer
- Have taken part in another trial looking at custirsen (OGX-011)
- Have any other type of cancer apart from non melanoma skin cancer or superficial bladder cancer
- Have another medical condition such as heart failure, high blood pressure or a bad infection that cannot be controlled with medication, a recent heart attack or stroke
This is an international phase 3 trial that will recruit about 800 men. It is a randomised trial. The men taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- Men in group A have docetaxel, prednisolone and custirsen
- Men in group B have docetaxel and prednisolone
If you cannot take prednisolone for some reason, you can still join the trial and have just docetaxel and custirsen, or docetaxel alone.
You have 3 week cycles of treatment. Everybody taking part has
- Docetaxel through a drip into a vein on the first day of each treatment cycle
- Prednisolone tablets for the first 5 days of each cycle
Just before starting docetaxel and prednisolone, men in group A have custirsen on 3 separate occasions over a 9 day period. You have it through a drip into a vein (an infusion) which takes about 2 hours each time. This is called a loading dose and ensures that you have enough custirsen in your body when you start the treatment cycles. During the treatment cycles, men in group A have an infusion of custirsen each week.
If the trial treatment is helping you and not causing bad side effects, you may have up to 10 cycles of treatment.
You will see the trial team and have some tests before you start treatment. The tests include
Men in group A go to hospital on days 1, 8 and 15 of each treatment cycle. Men in group B go to hospital just on day 1 of each cycle. A member of the trial team will contact them by phone on days 8 and 15 to see how they are.
You have blood tests in each treatment cycle. You have a scan after cycles 4, 6 and 10.
When you finish the treatment, you go to see the trial team about 3 weeks later. You then have appointments once every 4 weeks, but if your cancer gets worse, this will go down to once every 12 weeks.
As custirsen is quite a new drug, there may be side effects we don’t know about yet. In other clinical trials looking at a combination of custirsen, docetaxel and prednisolone, the most common side effects included
- Tiredness (fatigue)
- Feeling or being sick
- High temperature (fever)
- Loss of appetite and taste changes
- Diarrhoea or constipation
- Hair loss
- Shortness of breath
- Swelling in your legs
- Difficulty sleeping
- Joint or muscle pain
- Numbness and tingling in your hands and feet (peripheral neuropathy)
- Hot flushes
You may have a fever, chills and flu like symptoms the first few times you have custirsen. The trial team will give you other medication such as ibuprofen or paracetamol to try to stop this happening.
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.
Professor Johann de Bono
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
Teva Pharmaceutical Industries Ltd