"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 looking at a hormone therapy to treat advanced cancer of the prostate (SAKK 08 11)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at an experimental medicine called Orteronel, to see how well it works and how it affects men’s quality of life. This trial is supported by Cancer Research UK.
If you have advanced prostate cancer that has stopped growing after completing docetaxel chemotherapy, you would usually stop treatment and have regular check ups with your specialist. If your cancer started to get worse, your specialist would discuss further treatment with you.
Researchers in this trial are looking to see if an experimental drug called Orteronel can stop your cancer growing for longer. Orteronel works by blocking production of the male sex hormone
Men in the trial will take either Orteronel or a dummy tablet (placebo). And, complete questionnaires asking about their
- How well Orteronel works to keep the cancer stable
- How well the men taking part cope with side effects of the drug
Who can enter
You may be able to enter this trial if
- You have prostate cancer
- You have had either surgery to remove your testicles, or are taking a hormone therapy called a GnRH analogue, such as leuprorelin, goserelin or degarelix, but your cancer continued to grow, so you completed a course of docetaxel chemotherapy in the last 6 weeks, and your cancer has not got any worse
- You agree to continue taking GnRH analogue treatment if you were on this before
- Your cancer has spread to another part of your body, apart from your brain or spinal cord
- You have satisfactory blood test results
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Your heart is working well enough – your doctor will test for this
- You are able to swallow tablets whole
- You are willing to use reliable contraception during the trial, and for 4 months afterwards if there is any chance that your partner could become pregnant
- You are at least 18 years old
You cannot enter this trial if
- Your cancer is causing pressure on your spinal cord (spinal cord compression)
- You have had radiotherapy in the last 2 weeks
- You have had chemotherapy apart from docetaxel in the last 12 months
- You had further docetaxel after a break of at least 5 weeks
- You have had treatment with a drug that blocks an enzyme in your body called CYP17, such as abiraterone (Zytiga) – you can ask your doctor about this
- You are taking a daily dose of 10 mg or more of a steroid such as prednisolone for another condition – you can ask your doctor about this
- You are allergic to any of Orteronel’s ingredients
- You have had any other trial drugs in the last 30 days
- You have had any other cancer in the last 2 years, unless it was a very early stage and has been successfully treated – the trial team can advise you about this
- You have high blood pressure that is uncontrolled
- You have a condition that may affect how your body takes in (absorbs) or copes with the trial drug
- You have hepatitis B or hepatitis C
- You have any other illness that could make you unwell if you took part, or affect the results of the trial
This phase 3 trial will recruit 192 men in the UK and Switzerland. About 90 men will take part from the UK. It is randomised. The men taking part will be put into one of 2 groups by a computer. Neither you nor your doctor will be able to decide or know which group you are in. This is called a double blind trial.
Half the men take Orteronel tablets. The other half take a dummy drug (placebo). You take 3 tablets each morning and evening, with water. You record the doses and when you took them each day in a diary. You won’t know if you are taking Orteronel or the dummy drug.
If you have not had surgery to remove your testicles, you will carry on having hormone therapy to lower your testosterone levels.
You continue in the trial until your cancer starts to get worse.
The trial team will ask you to fill out a questionnaire before you start treatment, and regularly throughout treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
After you finish the trial, the team will contact you or your GP every 3 months to see how you are getting on.
The team may ask if they can use samples of your prostate cancer that were taken when you were diagnosed, or that might be taken in future as part of your routine care. They will use these for research now and in the future. You do not have to agree to this if you don’t want to. You can still take part in the rest of the trial.
Before you start the trial, you see the doctor and have some tests. These tests include
- Physical examination
- Blood tests
- CT scan or MRI scan
- Chest X-ray (if needed)
- Bone scan
- Heart trace (
- Heart scan (
echocardiogram) or MUGA scan
During the trial you see the doctor and have regular
- Blood tests
- CT scan or MRI scans
- Bone scans
- Heart ultrasounds
- Heart traces
When you finish the trial you see the doctor and give a blood sample. If you stopped for a reason other than your cancer getting worse, you continue to see the team every 3 months and have
- A blood test
- CT scan, MRI scan or X-ray
- Bone scan
The most common side effects of Orteronel include
- Tiredness (fatigue)
- Feeling or being sick
- Loss of appetite
- Swelling of feet or legs
- Pain or discomfort in muscles, bones or joints
- Feeling hot and sweaty
- High blood sugar
- Tummy pain
- High blood pressure
- Weight loss
- Temporary changes to the way your liver and kidneys work
- Muscle weakness
- Needing to pass urine more at night
- Difficulty breathing
- Skin rash
You can talk to the trial team about other less common side effects of Orteronel.
You will have some extra radiation from the trial scans. But the trial team think that any risk to you would be very small.
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 Simon Crabb
Cancer Research UK
NIHR Clinical Research Network: Cancer
Swiss Group for Clinical Cancer Research
University Hospital Southampton NHS Foundation Trust
This is Cancer Research UK trial number CRUKE/12/023.