"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 hormone therapy with other treatments for prostate cancer (STAMPEDE)
This trial is comparing hormone therapy alone with a combination of hormone therapy and one or more other treatments for prostate cancer. Cancer Research UK supports this trial.
Doctors often use hormone therapy to treat prostate cancer that has spread outside the prostate gland. It can work very well, but the cancer often starts to grow again at some stage. Doctors think that having other treatments at the same time as hormone therapy may work better.
In this trial, everybody will have standard hormone therapy as they usually would. But some will have other treatments as well. The treatments are
- A bisphosphonate called zoledronic acid (zoledronate or Zometa)
- A chemotherapy drug called docetaxel (Taxotere)
COX-2 inhibitorcalled celecoxib
- A new drug called abiraterone
- Radiotherapy to the prostate
- A hormone therapy called enzalutamide (Xtandi)
- A drug called metformin
The aim of this trial is to see which treatment is best for prostate cancer that has spread outside of the prostate gland.
More about this trial
In May 2015, the first results from the trial were presented at an international cancer research conference. They showed that men having docetaxel as well as standard treatment lived on average 10 months longer than men who had standard treatment alone. And the increase in the length of time men lived was even greater for those who had cancer that had already spread to other parts of the body.
At the same time, results showed that men who had the drug zoledronic acid as well as standard treatment didn’t live any longer than men who had standard treatment alone. And adding zoledronic acid to docetaxel did not seem to add any additional benefit to having docetaxel and standard treatment.
The trial team are continuing to follow up all the men who are taking part in the trial to find out more about the long term side effects of these drugs. As and when more results become available, we will update the information on this page.
The trial continues to recruit men into groups comparing some of the other treatments listed above.
Who can enter
You can enter this trial if
- You have recently been diagnosed with prostate cancer that has spread outside the prostate gland into your lymph nodes or to another part of your body
- You have recently been diagnosed with prostate cancer that has not spread outside the gland if at least 2 of the following apply to you - your prostate cancer has broken through the capsule covering the gland, you have a PSA level of 40 or above, or you have a Gleason score of 8 or above
- You have prostate cancer that has started to grow again following surgery or radiotherapy and has now either spread into your lymph nodes or to another part of your body, or you have a PSA level of 20 or more, or a PSA level above 4 if it has doubled in less than 6 months
As well as that, you must
- Be due to have hormone treatment for your prostate cancer
- Be up and about for at least half the day (performance status 0, 1 or 2)
- Have satisfactory blood test results
You cannot enter this trial if you
- Have prostate cancer that has spread to the brain
- Have had any cancer treatment that reaches the whole body (
systemic treatment) for prostate cancer apart from hormone therapy
- Have any other cancer that the doctors think may affect the treatment or the trial results
- Have numbness or tingling in your hands or feet (peripheral neuropathy) unless it is very mild
- Have had surgery in the last 4 weeks
- Have a serious heart condition, high blood pressure that cannot be controlled with medication or have had a heart attack or stroke in the past
- Take other medication that can affect an enzyme called CYP3A4
The trial has already recruited 9,000 men. The team need about another 1,250 men to join. It is a randomised trial. The men taking part are put into treatment groups by a computer. Neither you nor your doctors will be able to decide which group you are in.
Please note - Groups B to J already have enough men taking part and are now closed to recruitment. From March 2016, men joining the trial will be able to join group A or group K.
- Group A have just hormone therapy or an orchidectomy
- Group B have hormone therapy or an orchidectomy, plus zoledronic acid (zoledronate or Zometa)
- Group C have hormone therapy or an orchidectomy, plus docetaxel (Taxotere)
- Group D have hormone therapy or an orchidectomy, plus
- Group E have hormone therapy or an orchidectomy, plus zoledronic acid and docetaxel
- Group F have hormone therapy or an orchidectomy, plus zoledronic acid and celecoxib
- Group G have hormone therapy or an orchidectomy, plus abiraterone tablets
- Group H have hormone therapy or an orchidectomy, plus radiotherapy to the prostate
- Group J have hormone therapy or an orchidectomy, plus abiraterone and enzalutamide
- Group K have hormone therapy or an orchidectomy, plus metformin
All the men taking part will have hormonal treatment. This could be hormone injections, tablets or an operation to remove both testicles (an orchidectomy). The hormone testosterone is made by the testicles, so if they are removed, the level of testosterone falls dramatically. Any other treatment you have will depend on which treatment group you are in.
If you are in group K, metformin is a tablet you take once a day with food or after food.
The trial team will ask you to fill out a number of questionnaires during the trial. These ask about any side effects you have had and about how you have been feeling. This is called a quality of life study. The questionnaires may also have some questions about what health services you have used during the time you are on the trial.
The trial team will also ask for an extra blood sample, a sample of spit (saliva) and a sample of tissue taken when your cancer was diagnosed. They will look at the DNA and proteins in your samples to learn more about the causes of prostate cancer and how it responds to different treatments. If you don’t want to give samples for this study, you don’t have to. You can still take part in the trial.
You will see the doctors and have some tests before you can take part in this trial. The tests include
- CT scan or MRI scan
- Bone scan
- Chest X-ray
- Heart trace (ECG)
- Blood tests (including a PSA test)
- Physical examination
How often you go to the hospital for treatment will depend on which group you are in. But everybody taking part will see the trial team
- Every 6 weeks for the first 6 months
- Every 3 months up to 2 years
- Then every 6 months up to 5 years
- Once a year after that
The most common side effects of hormone therapy or orchidectomy are
- Decreased sex drive
- Hot flushes
- Breast swelling and tenderness
The most common side effects of zoledronic acid are
- Flu like symptoms
The most common side effects of docetaxel are
- Hair loss
- A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness or breathlessness
- Swelling of hands and feet (fluid retention)
- Feeling or being sick
- Sore mouth
The most common side effects of abiraterone are
- Fluid retention
- High blood pressure
- Low levels of potassium in your blood
- Hot flushes
- A drop in the number of red blood cells (
- Tummy (abdominal) pain
- Feeling or being sick
- Joint pain
- Diarrhoea or constipation
- Changes to the way your liver works
- An increase in the amount of sugar (glucose) in your blood
The most common side effects of radiotherapy to the prostate are
- Inflammation of the bladder
- Inflammation of the back passage (proctitis)
- Sore skin in the genital area
- Problems passing urine
- Erection problems
The most common side effects of enzalutamide are
- Hot flushes
- Loss of fertility
The most common side effects of metformin are
- mild tummy (abdominal) cramps
- change in appetite and taste
- feeling sick
We have more information about the side effects of
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 Nick James
Cancer Research UK
Department of Health
Experimental Cancer Medicine Centre (ECMC)
Janssen Pharma PV
Medical Research Council (MRC)
MRC Clinical Trials Unit at UCL
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUK/06/019