Welcome to the STAMPEDE website.
We will be adding regular updates about the trial and have made all of the trial documentation available for you to download. Please check the site regularly and add us to your favourites!
Prostate cancer accounts for around one fifth of all male cancers. In the UK there are around 47,000 new cases each year and around 10,800 deaths. Most men with prostate cancer are given hormone therapy and this is often effective for a short time at stopping the tumour growing. However in most cases over time the tumour will start to grow again.
The aim of this trial is to try to prevent the tumour re-growth by adding other treatment to the hormone therapy. The trial is currently assessing abiraterone and enzalutamide in combination with hormone therapy or radiotherapy (newly diagnosed metastatic patients only) in combination with hormone therapy.
The “M1|RT comparison” opened to recruitment in January 2013 and has progressed through all its pre‑planned
interim analyses. The IDMC has also recently had the opportunity to carry out an annual review of the data.
The TMG and TSC have had the opportunity to discuss recruitment progress and have agreed that this comparison
will close to recruitment in Sep-2016.
All randomisations to Arm H will therefore stop on Friday 02-Sep-2016 at 5pm.
The closure to recruitment to Arm H will shortly be followed by the launch of the “metformin comparison”
(Arm A vs Arm K) on Monday 05-Sep-2016.
We hope that this timeline will allow for a seamless change between the closure of one comparison and the
opening of a new one with minimal impact and administrative burden to centres.
The “enzalutamide +abiraterone comparison” has progressed through its first intermediate analysis and the second intermediate analysis is planned for March 2016. Thanks to the amazing enthusiasm and support by all participating centres, we are now fast approaching the recruitment target of approximately 1,800 patients. Current accrual rates and projections indicate that the target will be reached by the end of Q1-2016.
For this reason, all randomisations to Arm J will stop on Thursday 31-Mar-2016 at 5pm.
Recruitment to the trial continues to the “M1/RT comparison” which looks at radiotherapy-to-the-prostate in men whose disease has already spread elsewhere. This was the second new comparison, initiated in January 2013. A forth new comparison, the “metformin comparison”, should start recruitment in April with the initiation of Arm K. More information will follow.
More than 7,900 patients from across the UK and Switzerland have joined STAMPEDE, demonstrating the feasibility and benefits of conducting new comparisons within an ongoing trial.
The STAMPEDE team would like to thank all of the site staff and patients involved in the trial.
The survival results from the “original comparisons” have been now published on The Lancet. A copy of the Open Access paper can be viewed on the MRC CTU website and a link is provided here for your information:
The Lancet paper
A meta-analysis of the STAMPEDE results and similar trials has also been published in The Lancet Oncology
Two briefing papers have also been put together summarising the findings from the “original comparison” as well as the recommendations that followed. These can be found here
Finally, two short films (15 min) have been produced aimed at patients, the public and health workers to explore and discuss the results
Results film for patients
Results film for health workers
Thank you for all your support and for help making these practice-changing results available to the clinical community.