"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.
Please note, some parts of the STAMPEDE trial have results. We have a separate summary of the STAMPEDE trial results. These results have changed the way prostate cancer is treated. There are now more options for treatment when a man is first diagnosed with high risk prostate cancer.
More about 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, most men have standard hormone therapy as they usually would. Some will have other treatments as well, or will have a different treatment instead of hormone therapy. The differerent treatments include
- 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
- A hormone patch called transdermal oestradiol
The aim of this trial is to see which treatment is best for prostate cancer that has spread outside of the prostate gland.
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 10,000 men so far. 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 - group A, group K and group L are open for men to join. These groups are as follows.
- Group A have hormone therapy or an orchidectomy, some men might also have radiotherapy and or a chemotherapy drug called docetaxel and some might have a targeted drug called abiraterone. These are standard of care treatments
- Group K have standard of care treatment, plus metformin
- Group L have the transdermal oestradiol patch, as a replacement of the hormone therapy with standard of care treatments
The following groups are now closed and no more men can join. These groups are as follows.
- Group B have standard of care treatment, plus zoledronic acid (zoledronate or Zometa)
- Group C have standard of care treatment, plus docetaxel (Taxotere)
- Group D have standard of care treatment, plus
- Group E have standard of care treatment, plus zoledronic acid and docetaxel
- Group F have standard of care treatment, plus zoledronic acid and celecoxib
- Group G have standard of care treatment, plus abiraterone tablets
- Group H have standard of care treatment, plus radiotherapy to the prostate
- Group J have standard of care treatment, plus abiraterone and enzalutamide
Please note, some parts of the STAMPEDE trial have results. We have a separate summary of the STAMPEDE trial results.
Open groups (Group A, K and L)
All men in groups A and K have hormonal treatment. This could be hormone injections 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.
In Group L, the transdermal oestradiol patch is put on a hairless part of the skin on the upper body. The hormone is gradually absorbed through the skin. You have this instead of hormone therapy as described above. Research suggests that having hormone treatment this way may reduce side effects.
To start with you have 4 patches changed twice a week, for example Monday and Thursday, for 4 weeks. After 4 weeks your hormone levels are checked. If the levels are satisfactory you then have 3 patches changed twice a week.
If you are in group K, metformin is a tablet you take once a day with food or after food.
Quality of life
The trial team may ask you to fill out a number of questionnaires during the trial. These ask about any side effects that 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.
Samples for research
The trial team may 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
This also depends on when you join the trial. For example if you joined before November 2011, the trial doctor will tell you more about any specific follow up appointments.
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
- Skin irritation to site where patch applied
- Hot flushes
- Mood changes
- Weight gain
We have more information about the side effects of
How to join a clinical trial
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