MRC Clinical Trials Unit at UCL
90 High Holborn
What is STAMPEDE and why are we doing this study?
STAMPEDE (Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy) is a large clinical trial that aims to assess new treatment approaches for people affected by high-risk prostate cancer. The trial has been open since 2005 and has tested many different ways of treating prostate cancer and some results are now already known. Each new or alternative treatment is compared with the current standard approach, referred to as a "comparison". More than 10,000 people have joined STAMPEDE so far with answers becoming available throughout the trial as information on life expectancy and disease control rates are gathered and compared.
All trial participants are asked whether they would like to join some of the sub-studies being run alongside the trial. These aim to address several additional research questions such as what effect each treatment has on quality-of-life (QL), and which provides the greater value for money for the health service. Some sub-studies are focused on improving our understanding of the biology of prostate cancer. For example, can genetic changes be identified in prostate cancer cells that could predict which treatments might work best and may explain why some treatments stop working?
What have the results of the trial shown so far?
In the past STAMPEDE also tested whether adding docetaxel chemotherapy, zoledronic acid, or celecoxib, alone or in combination, was beneficial in controlling prostate cancer growth and improving life expectancy. Recruitment has been completed to all of these original treatment groups, the results have been presented.
The addition of docetaxel was shown to benefit patients and this has led to a change in clinical practice. See the summary of results that we prepared for the STAMPEDE participants letting them know about the details of these results STAMPEDE participant summary 2016
In results presented in June 2017, the addition of abiraterone to androgen-deprivation therapy has also been shown to be beneficial. See the summary of results that we prepared for the STAMPEDE participants letting them know about the details of these results.
In results presented in October 2018, the provision of radiotherapy to patients with metastatic prostate cancer, resulted in a substantial improvement in survival for some men.
STAMPEDE: Docetaxel and Zoledronic Acid Results
Check out the "Docetaxel and Zoledronic Acid Comparisons" Results Summary Sheet and watch the video below.
STAMPEDE "Abiraterone Comparison" Results
Check out the "Abiraterone Comparison" Results Summary Sheet and watch the video below.
We are still collecting data on the recently closed combination Enzalutamide and Abiraterone comparison. Information will be published in the coming years.
STAMPEDE "M1 Radiotherapy Comparison" Results
Check out the "M1 Radiotherapy Comparison" Results Summary Sheet and watch one of the videos below (there is a full version and a shorter version):
When will more results be known?
New information may become available about the treatments you receive during the study. If this happens, your study doctors will tell you about it and talk with you about whether you want to continue with treatment.
Further results are expected in the next few years from other treatments tested in STAMPEDE, which have completed recruitment. This include a treatment combination currently used in different settings, abiraterone and enzalutamide, both currently used when hormone treatment is no longer effective and the cancer has started to grow again, termed castrate-resistant prostate cancer (CRPC).
Further results are expected following that from other treatments tested in STAMPEDE, which are still recruiting.
What do I need to know about the treatments currently being tested?
Metformin: Metformin is a diabetic treatment that may also have an effect on prostate cancer growth and help prevent some of the side effects of hormone treatment. Only men without diabetes can join Treatment Group K, therefore all men wishing to take part must have a blood test to check for diabetes first.
Transdermal oestradiol: Hormone patches containing transdermal oestradiol are being assessed as an alternative form of hormone therapy. STAMPEDE is looking at whether transdermal oestradiol can work as well as, or better than, standard hormone therapy in treating the cancer longer-term. Men with diabetes can join this group, but men should switch from standard hormone treatment to alternative patches soon after hormone treatment is first started.
What treatment might I receive if I chose to take part?
New participants joining the trial from protocol v19.0 onwards may be eligible to join one of two treatment comparisons:
- The "metformin comparison" made between the control arm (arm A) who receive standard treatment only and the metformin treatment group (arm K) who receive standard treatment and metformin.
- The "transdermal oestradiol comparison" made between the control arm (arm A) and the transdermal oestradiol treatment group (arm L) who receive transdermal oestradiol as an alternative form of standard hormone treatment.
Eligibility for each treatment group is dependent on several factors including the stage of prostate cancer, whether it has spread to involve other parts of the body (metastatic), and how long a patient has received hormone therapy prior to joining STAMPEDE. A computer program will be used to randomly allocate participants between all treatment groups for which they are eligible.
What about taking part?
If you are interested in taking part please talk to your medical team, the STAMPEDE map shows all of the hospitals taking part in the trial.
MRC Clinical Trials Unit at UCL