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STAMPEDE Trial recruits its 10,000th participant

11 April 2018

As the STAMPEDE trial recruits its 10,000th participant, we would like to mark this milestone and take the opportunity to thank everyone involved, particularly participants and their families, all the hundreds of hospital staff involved and the staff at the MRC CTU at UCL. It would not be possible to help improve care for men with advanced prostate cancer without the dedication and continued involvement of all of these people.

Impact on treatments for patients with prostate cancer

STAMPEDE is the largest ever prostate cancer treatment trial. The study has already demonstrated improved survival with the addition of either docetaxel or abiraterone to standard-of-care treatment for men starting long-term hormone therapy. The clinical results from STAMPEDE on docetaxel were published in early 2016 and have changed the treatment for men with prostate cancer worldwide.

Docetaxel is now available on the NHS to men with cancer that has spread to distant parts of their body. However, it is not currently widely available to men with locally-advanced disease who are starting long-term hormone therapy. A more recent analysis of the STAMPEDE data supports use in these men and the researchers are urging clinicians to consider whether these men should be offered docetaxel. The extension of use of docetaxel in these men is currently under consideration by NICE.

The data showing the survival benefits of the drug abiraterone were published summer 2017, and NICE are in the process of reviewing whether men with metastases starting long-term hormone therapy should have routine access to this drug in the NHS.

Trial Chief Investigator Nick James said: "It has been an honour and a privilege to be involved in the practice changing STAMPEDE trial. The impact of the study has been on men with the disease worldwide and is a tribute to the UK clinical trials research community."

Since opening to recruitment in 2005, STAMPEDE has already tested and published data on whether adding docetaxel chemotherapy, abiraterone, zoledronic acid, or celecoxib, is beneficial in controlling prostate cancer growth and improving life expectancy. Further results on prostate radiotherapy, the combination of abiraterone and enzalutamide, metformin and oestrogen patches are due in the next few years.

Max Parmar, Director of MRC CTU at UCL and the UCL Institute of Clinical Trials and Methodology, and originator of the multi-arm multi-stage design said: "The ground-breaking multi-arm, multi-stage platform approach in the STAMPEDE protocol has allowed us to test far more therapies more rapidly than a more conventional trial design. The huge success of STAMPEDE has led to this design being used in many other diseases including other cancers, TB, HIV and Hepatitis-C."

Lead Trial Statistician Matt Sydes said: "The UK and Switzerland have shown fantastic nationwide support to make this research happen. The trial has brought together multiple funders, both academic and industry. We are in discussions about testing further new treatments to STAMPEDE."

Innovative design

STAMPEDE, which continues to recruit new men, implements the innovative multi-arm, multi-stage platform protocol design. The multi-arm multi-stage or 'MAMS' design, developed by the MRC CTU at UCL, allows assessment of several treatments against a single control arm, and for recruitment to be stopped early to insufficiently active research arms; the platform element allows new treatments to be added to the trial as it progresses.