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

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 celecoxib (Celebrex)
• 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 fewer patches. These are changed twice a week. 

If you are in group K, metformin is a tablet you take every day with food or after food. The team will tell you how often to take the tablets. 

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.