Landmark prostate cancer trial STAMPEDE finishes recruitment
31 Mar 2023
After nearly 20 years of studying treatments for prostate cancer, the STAMPEDE clinical trial has finished recruiting new participants. Follow-up for the final patients will continue until the last analysis in 2025.
Results from STAMPEDE have directly improved the treatment of advanced prostate cancer in the UK and beyond. Meanwhile, the trial’s pioneering methodology set an example for clinical trials across many disease areas.
Recruitment opened in 2005 in hospitals across the UK and later in Switzerland. Since then, almost 12,000 men who were starting long-term hormone therapy for prostate cancer have taken part, making it one of the largest ever clinical trials in prostate cancer.
As a multi-arm, multi-stage (MAMS) platform trial, STAMPEDE tests multiple treatment options at the same time, while comparing them all against one control group who receive standard care. It has also added new treatment comparisons over time and dropped other treatments if they were not effective.
The efficiency of the MAMS design means STAMPEDE has made progress that may have taken many decades in a traditional clinical trial.
In 2015, STAMPEDE showed that adding the chemotherapy drug docetaxel to standard hormone therapy treatment helped men with cancer that had spread beyond the prostate to live longer. This led the NHS to approve the use of docetaxel in combination with hormone for these men. Docetaxel is now offered as part of standard treatment.
STAMPEDE’s finding that radiotherapy improved survival for men whose cancer had spread to only a few places around the body also informed NHS England’s decision to recommend radiotherapy for this group of men in 2020.
The trial has also helped make a particular kind of hormone therapy called abiraterone more widely available. 2017 results showed that abiraterone extended life in men with prostate cancer that had spread beyond the prostate. Most recently, NHS Scotland approved the use of abiraterone in patients with prostate cancer which had not yet spread elsewhere, but was at high risk of spreading. This decision was based on data from STAMPEDE providing evidence that abiraterone reduced the risk of death or the cancer spreading.
STAMPEDE has been a huge collaborative effort, with 165 researchers and over 5,000 NHS staff working across 126 hospitals in the UK and Switzerland.
None of this would have been possible without the people who volunteered to take part in STAMPEDE over the years. The MRC CTU would like to thank them for their invaluable contributions.
While recruitment has now closed, existing participants will continue to take their study medication and attend medical assessments for a few more years. The STAMPEDE team will then analyse the data and release results on the final two comparisons testing metformin (a drug used to treat type 2 diabetes) and transdermal oestradiol hormone patches (an alternative way to deliver hormone therapy).
Work has also begun on setting up STAMPEDE2, a second clinical trial which will open later this year in patients whose cancer has spread beyond the prostate. STAMPEDE2 will continue delivering impactful research and improvements in care for the prostate cancer community.
STAMPEDE was funded by the Medical Research Council and Cancer Research UK, with extra support from pharmaceutical companies: Pfizer, Sanofi-Aventis, Novartis, Janssen, Astellas and Clovis.
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