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

Cancer type:

Prostate cancer

Status:

Open

This trial is comparing hormone therapy alone with a combination of hormone therapy and one or more other treatments for prostate cancer. This trial is supported by Cancer Research UK.

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

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

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 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

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 Open a glossary item) 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 Open a glossary item, 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 probably recruit about 7,000 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.

  • 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 Open a glossary item
  • 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

Please note - Groups B to G already have enough men taking part and are now closed to recruitment. From July 2014, men joining the trial will be able to join group A, group H or group J.

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 H, you have radiotherapy either once a week for 6 weeks, or 5 times a week for 4 weeks. If you have radiotherapy 5 times a week for 4 weeks, each dose is lower than if you have it weekly, but the total dose is a bit higher.

If you are in group J, you have enzalutamide capsules and abiraterone tablets once a day, every day. You will have treatment for 2 years, or until there are signs that your cancer has started to grow again.

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.

Hospital visits

You will see the doctors and have some tests before you can take part in this trial. The tests include

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

The most common side effects of abiraterone are

  • 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 Open a glossary item)
  • 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
  • Diarrhoea
  • 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

  • Tiredness
  • Hot flushes
  • headaches
  • Loss of fertility

We have more information about the side effects of

Location

Aberystwyth
Airedale
Ashford
Aylesbury
Ayr
Barnet
Basingstoke
Bath
Belfast
Birmingham
Blackburn
Bolton
Boston
Bournemouth
Bradford
Brighton
Bristol
Burnley
Burton on Trent
Bury St Edmunds
Cambridge
Canterbury
Cardiff
Carlisle
Chelmsford
Chester
Colchester
Coventry
Crewe
Darlington
Derby
Doncaster
Dorchester
Dudley
Durham
Eastbourne
Edinburgh
Exeter
Forth Valley
Glasgow
Guildford
Harlow
Hastings
Hereford
High Wycombe
Huddersfield
Hull
Inverness
Ipswich
Kidderminster
Leeds
Lincoln
Liverpool
London
Maidstone
Manchester
Margate
Middlesbrough
Newcastle upon Tyne
Newport
Northwood
Nottingham
Nuneaton
Oldham
Oxford
Poole
Portsmouth
Preston
Reading
Redditch
Romford
Salford
Scarborough
Sheffield
Shrewsbury
South Shields
Southampton
Southend on Sea
Southport
Stockport
Stockton-on-Tees
Sunderland
Sutton
Sutton in Ashfield
Swansea
Swindon
Taunton
Torquay
Warrington
Warwick
Weston Super Mare
Whitehaven
Wigan
Worcester
Worthing

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Nick James

Supported by

Cancer Research UK
Astellas
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
Novartis
Sanofi

Other information

This is Cancer Research UK trial number CRUK/06/019.

We have more information about the work of Professor Nick James.

Contact our cancer information nurses for other questions about cancer by:

Phone - 0808 800 4040

Last review date

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Keith took part in a trial looking into hormone therapy

"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”

Last reviewed:

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