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

Cancer type:

Prostate cancer
Secondary cancers

Status:

Results

Phase:

Phase 3
This is a summary of the results of the STAMPEDE trial that the team have published so far. 
 
The study includes men who:
  • have a high risk of the cancer spreading or prostate cancer that has already spread to the lymph nodes Open a glossary item or elsewhere in the body
  • are starting long term hormone therapy for the first time
  • are fit enough to have chemotherapy
There are a number of different treatment groups in this trial. Some are still open for men to take part in. But most of the groups have closed and some have results available. 
 
Cancer Research UK supports this trial.
 
Please note: This summary has information about the results of the STAMPEDE trial so far.  We have a separate summary of the STAMPEDE trial, as some parts are still open for men to join.

More about this trial

One of the usual treatments for prostate cancer that has spread outside the prostate gland or has a risk of spreading is hormone therapy. This blocks or lowers the amount of testosterone Open a glossary item in the body. 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 than hormone therapy alone.
 
In this trial, everybody has standard hormone therapy as usual. And some have other treatments as well.
 
These treatments are:
  • a drug called zoledronic acid 
  • a chemotherapy drug called docetaxel 
  • an anti inflammatory drug called celecoxib
  • another type of hormone therapy called abiraterone
  • radiotherapy to the prostate
  • another type of hormone therapy called enzalutamide
  • a drug called metformin
  • a hormone patch called transdermal oestradiol
The aim of this trial is to see if adding these treatments to hormone therapy improves treatment for prostate cancer.

Summary of results

The trial team have published some results for the STAMPEDE trial. In summary, the main findings are:
  • adding docetaxel to hormone therapy improves the length of time men live – this is called overall survival
  • adding abiraterone to hormone therapy improves overall survival and delays the time until the cancer gets worse
  • adding radiotherapy to hormone therapy in men with less prostate cancer spread improves overall survival
  • celecoxib doesn’t help men live longer 
There is a detailed summary of each published result below. 
 
About this trial
This is a phase 3 trial. There are a number of different treatment groups in this trial. It compares usual hormone therapy with usual hormone therapy and one or more other treatments.
 
Usual hormone therapy might include:
  • injections or implants to stop the testicles making testosterone or to block the effects of testosterone
  • surgery to remove the testicles or the parts of the testicles that make testosterone - this is called an orchidectomy
Men having injections or implants had them for at least 2 years.
 
The following groups are still open for men to join:
 
Group A have hormone therapy 
Group K have hormone therapy and metformin
Group L have the transdermal oestradiol patch
 
The following groups are closed and some have results:
 
Group B had hormone therapy and zoledronic acid
Group C had hormone therapy and docetaxel 
Group D had hormone therapy and celecoxib  
Group E had hormone therapy, zoledronic acid and docetaxel
Group F had hormone therapy, zoledronic acid and celecoxib
Group G had hormone therapy and abiraterone 
Group H had hormone therapy and radiotherapy to the prostate
Group J had hormone therapy, abiraterone and enzalutamide
 
Results for hormone therapy alongside docetaxel, zoledronic acid or both (Group B, group C and group E)
Men joined this part of the trial between 2005 and 2011. These results were published in 2016.
 
2,962 men took part. They were put into treatment groups at random:
  • 1,184 had hormone therapy 
  • 593 had hormone therapy and zoledronic acid
  • 592 had hormone therapy and docetaxel
  • 593 had hormone therapy, zoledronic acid and docetaxel
Some men, whose cancer hadn’t spread to lymph nodes or elsewhere in the body also had radiotherapy.
 
The researchers looked at how well treatment worked. To do this, they looked at how long men lived. This is called overall survival.
 
On average, this was:
  • 71 months in men who had hormone therapy
  • 81 months in men who had hormone therapy and docetaxel
  • 76 months in men who had hormone therapy, zoledronic acid and docetaxel
So, men who had docetaxel alongside hormone therapy lived on average 10 months longer than men who had hormone therapy alone. But having zoledronic acid didn’t improve overall survival. 
 
Side effects
Men having docetaxel had more side effects. The most common were:
  • an increased risk of infection with a fever
  • an increased risk of infection
Over half of the men who had docetaxel had a serious side effect. 8 men who had docetaxel died from serious infections. 
 
Results for men who had hormone therapy and abiraterone (Group G)
Men joined this part of the trial between 2011 and 2014. The researchers published these results in 2017.
 
1,917 men took part. They were put into treatment groups at random:
  • 957 had hormone therapy
  • 960 had hormone therapy, abiraterone and the steroid drug prednisolone
Men whose cancer hadn’t spread to lymph nodes or elsewhere in the body also had radiotherapy.
 
The researchers looked at how well treatment worked. To do this, they looked at the number of men living at 3 years.
 
This was about:
  • 7 out 10 men (76%) who had hormone therapy (group 1)
  • 8 out of 10 men (83%) who had hormone therapy and abiraterone (group 2)

They also looked at whose cancer got worse. This happened in:
  • 535 men who had hormone therapy 
  • 248 men who had hormone therapy and abiraterone
So, having abiraterone alongside hormone therapy reduces the chances of the cancer spreading or coming back. 
 
Side effects 
Men who had abiraterone had worse side effects. The most common were:
  • changes in some blood test results
  • high blood pressure
  • breathing problems
Hormone therapy can cause bone problems. But the trial found that abiraterone reduced the risk of serious bone problems by a half.
 
Results for hormone therapy and celecoxib, some men also had zoledronic acid (Group D and group F)
Men joined this part of the trial between 2005 and 2011. Researchers published these results in 2017.
 
1,245 men joined this part of the trial. Of those:
  • 622 had hormone therapy
  • 312 had hormone therapy and celecoxib
  • 311 had hormone therapy, celecoxib and zoledronic acid 
The researchers did an early analysis of the results in 2012. They looked at how long men lived. This is called overall survival. These results did not show clearly that adding celecoxib with or without zoledronic acid improved overall survival for these men.
 
So, these parts of the trials closed early and no more men took part.
 
Results for hormone therapy and radiotherapy to the prostate (Group H)
Men joined this part of the trial between 2013 and 2016. They all had cancer that had spread elsewhere in the body (metastatic cancer). Researchers published these results in 2018.
 
2,061 men took part. They were put into treatment groups at random:
  • 1,029 had hormone therapy
  • 1,032 had hormone therapy and radiotherapy 
Some men also had docetaxel.
 
The researchers looked at how long men lived. To do this, they followed the men for a period of 3 years. The researchers found that on average, there was no difference in how long men in the 2 groups lived. So, adding radiotherapy to hormone therapy didn’t improve overall survival.
 
But they found that radiotherapy helped a specific group of men. The trial team looked at how far the cancer had spread.
 
In:
  • 819 men, the cancer had spread a little bit. This is called low metastatic burden. This means it hadn’t spread beyond lymph nodes Open a glossary item and/or nearby bones 
  • 1,120 men, the cancer had spread further – this is called a high metastatic burden
  • 122 men the trial team didn’t have this information 
At 3 years, researchers looked at the number of men living whose cancer had spread a little bit. This was about:
  • 8 out of 10 (81%) men who had hormone therapy and radiotherapy (group 1)
  • 7 out of 10 (73%) men who had hormone therapy (group 2)
Radiotherapy to the prostate gland also delayed the cancer getting worse. So, having radiotherapy with hormone therapy helped men who had a little cancer spread to live longer.

But they found that radiotherapy didn’t help men live longer if their cancer had spread further at the time of diagnosis. 
 
Side effects 
Men who had radiotherapy had more problems with their bladder or bowel. For example, problems passing urine or diarrhoea. These were expected side effects.
 
Main conclusions of the STAMPEDE trial so far
The researchers found that some of the treatments they added to hormone therapy improved overall survival for men whose prostate cancer had spread or had a high risk of spread. These included:
  • docetaxel
  • abiraterone which also reduces the chances of the cancer spreading or coming back 
  • radiotherapy in men with less prostate cancer spread (low metastatic burden) 
The treatments they added to hormone therapy that didn’t improve overall survival included:
  • celecoxib 
  • zoledronic acid and adding it to docetaxel didn’t add any extra benefit to having docetaxel and hormone therapy
The results of the STAMPEDE trial have changed the standard of care for men with prostate cancer. For example, docetaxel has become part of the treatment a man might have when he is first diagnosed.
 
Further results
The trial team are continuing to follow up all the men who are taking part in STAMPEDE. They want to find out more about the long term side effects of treatment.
 
We plan to update this summary when more results become available.
 
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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Recruitment end:

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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
Medical Research Council
Astellas
Clovis Oncology
Janssen
Novartis
Pfizer
Sanofi-Aventis

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16001

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

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