A trial looking at hormone therapy with other drugs for prostate cancer (STAMPEDE)

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

OR

• 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

OR

• You have prostate cancer that has started to grow again following surgery or radiotherapy and has now either spread into your lymph noes 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 chemotherapy or any other treatment that reaches the whole body (systemic treatment) for prostate cancer
• 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
• Have a peptic ulcer, bleeding into your gut or inflammatory bowel disease
• Have already had zoledronic acid, unless it was just for a short time to treat a raised level of calcium in your blood (hypercalcaemia)
• Have already had abiraterone
• Take other medication that can affect an enzyme called CYP3A4
• Are likely to need major dental work in the next 2 years

Trial design

The trial will recruit about 4,000 men all together. 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.

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 the testicles, so if they are removed, the level of testosterone falls dramatically. Some men may also have radiotherapy.

Any other treatment you have will depend on which treatment group you are in.

• 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 celecoxib
• 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 orchidetomy, plus abiraterone tablets

Please note - By April 2011, there were enough men in groups D and F. So men joining the trial after that were not put into either of those 2 groups. In November 2011, group G opened to recruitment. So men joining the trial since then are put into groups A, B, C, E or G.

If you are in group B or E, you have zoledronic acid as an injection into a vein once every 3 weeks for 18 weeks. Then once every 4 weeks for up to 2 years.

If you are in group C or E, you have docetaxel into a vein once every 3 weeks for 18 weeks. You also take steroid tablets called prednisolone every day during this time. If you are in group E, you will have zoledronic acid and docetaxel as separate injections on the same day, every 3 weeks for the first 18 weeks. You then have zoledronic acid every 4 weeks for up to 2 years.

If you are in group G, you have abiraterone tablets each day. You also take a steroid tablet each day. How long you take the tablets for will depend on the stage of your prostate cancer, and whether or not the treatment is helping you.

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. They will also ask for an extra blood sample 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.

Depending on where you are being treated, the researchers may ask you to take part in a sub study looking at the effect treatment has on your bones (bone density). If you agree to take part, you have a DEXA scan when you join the trial and then 1 year and 2 years later. You also give some extra blood and urine samples.

Hospital visits

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

Side effects

The most common side effects of hormone therapy or orchidectomy are

• Impotence
• Decreased sex drive
• Hot flushes
• Breast swelling and tenderness

The most common side effects of zoledronic acid are

• Flu like symptoms
• Tiredness

The most common side effects of docetaxel are

• Hair loss
• Rash
• 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
• Diarrhoea

The most common side effects of abiraterone include

• Tiredness
• Fluid retention
• High blood pressure
• Low levels of potassium in your blood
• Hot flushes
• A drop in the number of red blood cells (anaemia)
• 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

There is more information about the side effects of hormone therapy, docetaxel (Taxotere), zoledronic acid (zoledronate or Zometa), prednisolone and abiraterone on CancerHelp UK.