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A trial of custirsen with cabazitaxel and prednisolone for prostate cancer that has spread and is not responding to hormone therapy (AFFINITY)
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 cabazitaxel. It is for men who have prostate cancer that has spread to other parts of the body.
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. If prostate cancer starts to get worse after having docetaxel, you may have another chemotherapy drug called cabazitaxel with a steroid drug called prednisolone.
Some cancer cells produce a lot of a protein called clusterin. This may help the cells protect themselves from cancer drugs and stop the drugs working as well as they could.
In this trial, researchers are looking at a new drug called OGX-011 (custirsen) which can reduce the level of clusterin. They 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 cabazitaxel and prednisolone improves this treatment for men with prostate cancer that has spread, is not responding to hormone therapy and has got worse despite having docetaxel.
Who can enter
You may be able to enter this trial if you
- Have prostate cancer that has spread to your bones, lungs or tummy (abdomen)
- Have already had docetaxel and your cancer is now getting worse
- Are able to care for yourself even if you aren’t able to carry on with all your normal activities or do active work (Karnofsky performance status score of at least 70)
- Have recovered from the side effects of any earlier treatment (apart from hair loss,
anaemiaor the effects of anti androgen therapy) unless they are only mild
You cannot enter this trial if you
- Have had any other chemotherapy for prostate cancer - apart from docetaxel
- Have cancer that has spread to your brain or spinal cord
- Have cancer that is pressing on your spinal cord (spinal cord compression) and this needs treating with surgery or radiotherapy
- Have had internal radiotherapy (radioisotope therapy) such as strontium
- Have taken part in another phase 3 trial looking at custirsen
- Take other medication that can affect body proteins called cytochrome P (CYP) enzymes
- Have any other type of cancer (apart from non melanoma skin cancer or superficial bladder cancer) that needs treatment or is at high risk of coming back during the trial
- Are known to be very sensitive to
taxane drugsor drugs containing polysorbate 80 (the trial team can advise you about this)
- Have any other medical condition that the trial team think could affect you taking part
This phase 3 trial will recruit 630 men. It is a randomised trial. The people 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 cabazitaxel, prednisolone and custirsen
- Men in group B have cabazitaxel and prednisolone
If you are in group A, you start by having custirsen through a drip into a vein on 3 separate days in the 1st week. You then have it once a week and you also have a cabazitaxel through a drip every 3 weeks. You take prednisolone tablets every day. Each 3 week period is called a cycle of treatment.
If you are in group B, you have cabazitaxel every 3 weeks and you take prednisolone tablets every day.
As long as you don’t have side effects and your cancer is not getting worse, you can have up to 10 cycles of treatment.
You see the trial team and have some tests before you start treatment. The tests include
The trial team will also assess any cancer pain you have and ask about any painkillers you use.
Men in group A go to hospital every week to have treatment. Men in group B go to hospital every 3 weeks. The trial team will also contact men in group B by phone each week to see how they are doing.
You have blood tests before each cycle of treatment (about every 3 weeks). You may have extra CT and bone scans after the 4th cycle of treatment, about 5 months after joining the trial and again 6 weeks later.
When you finish treatment, the trial team will check how you are every 3 months. This may be a hospital visit, or they may phone you or your doctor.
As custirsen is a new drug, there may be side effects we don’t know about yet. The most common side effects seen with custirsen or cabazitaxel are
- 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
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.
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer