The STAMPEDE trial has received the '2017 David Sackett Trial of the Year Award' from the Society for Clinical Trials (SCT).
Each year since 2008, the SCT has presented the award to the randomized clinical trial published in the previous year that best fulfils exacting standards. The trial must provide the basis for a substantial, beneficial change in healthcare, reflect expertise, methodological excellence, and concern for its participants. The trial's design, execution, and results must be a model of clarity and intellectual soundness.
The international award was presented at the 39th SCT Annual Meeting held 20-23 May 2018, in Portland, Oregon. Professor Mahesh Parmar, Director of MRC CTU at UCL and the UCL Institute of Clinical Trials and Methodology, accepted the award on behalf of the STAMPEDE trial team.
Professor Parmar said: "The STAMPEDE trial's innovative design allows us to achieve answers to questions decades before the more traditional sequential two-arm trial approach to testing new treatments."
Started in 2005, STAMPEDE forged a path for other trials to adopt innovative trial designs, changing the research landscape. "STAMPEDE has pioneered the multi-arm, multi-stage platform randomised trial design and will answer 11 major questions over 20 years. This is decades faster than answering these questions in any other way. The STAMPEDE design has been adopted in other cancers, infectious diseases and plans are being developed to apply it to key neuro-degenerative diseases, such as Alzheimer's disease where we have no active treatments for this disease." said Professor Parmar.
The STAMPEDE trial aims to prevent prostate cancer tumour re-growth by adding other treatment(s) to hormone therapy. STAMPEDE is the largest ever prostate cancer treatment trial, having already recruited over 10,000 men.
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.
"Abiraterone not only prolonged life, but also lowered the relative chance of relapse and reduced the relative chance of serious bone complications." said STAMPEDE Chief Investigator Nicholas James, Professor of Clinical Oncology at Queen Elizabeth Hospital in Birmingham.