The NIHR-supported trial, STAMPEDE, set out find the best way of treating men with high risk prostate cancer by assessing the effect of a range of new treatments.
Published: 14 June 2019
The challenge
Prostate cancer is the most common form of cancer affecting men in the UK - with approximately 47,000 men diagnosed with the disease and 11,500 deaths each year.
The five-year survival rate for localised prostate cancer is nearly 100%. But for men diagnosed with prostate cancer that has already spread to other parts of the body, known as advanced or metastatic prostate cancer, only a third will survive for five years or more.
Prostate cancer is notoriously difficult to detect and significant numbers of men are not diagnosed until the cancer has already spread, significantly reducing their chance of survival.
How NIHR is making a difference
The NIHR-supported trial, STAMPEDE, set out find the best way of treating men with high risk prostate cancer by assessing the effect of a range of new treatments.
Since opening in 2005, the multi-arm trial has reported practice-changing evidence around the effectiveness of many different treatments - as information on life expectancy and disease control rates are established and compared. The study has made a global impact in how men presenting with more advanced disease are treated.
STAMPEDE is now the largest ever randomised controlled trial for men with prostate cancer. More than 10,000 men with high risk prostate cancer have taken part in the trial so far - with the NIHR supporting recruitment across over 125 UK sites.
Addition of docetaxel to first-line hormone therapy
One part of the trial tested whether a chemotherapy drug called docetaxel could improve outcomes if it was administered earlier, when men are just starting hormone therapy. Thanks to all those who took part in this arm of the trial, the findings have now led to a change in clinical practice.
Between 2005 and 2013, nearly 1200 men were allocated to a control group, receiving standard care (hormone therapy); while a further 600 men were allocated to the treatment group - where in addition to standard care, the participants were also treated with docetaxel.
The researchers looked at whether life expectancy was increased amongst those assigned to the docetaxel group; whether the disease stayed away for longer; and whether there were any adverse side effects associated with the treatment.
The trial showed that six doses of docetaxel increased survival gain by around 10 months, and for men with the worst disease - those in which the cancer had already spread at diagnosis - the survival gain was 16 months.
Although the addition of docetaxel increased side effects for some participants, overall it was shown to benefit patients whose cancer has spread to other parts of their body - increasing life expectancy, as well as the length time before their disease got worse.
As a result of STAMPEDE, the use of docetaxel is now the standard treatment on the NHS for men with high risk, locally advanced metastatic prostate cancer who are starting first line hormone therapy.
“The STAMPEDE trial has been world-leading in bringing about improvements in survival for men with advanced prostate cancer. It is a tribute to the UK trials infrastructure as well as the 10,000 plus men who have taken part.”
Chief Investigator of STAMPEDE, Professor Nicholas James, University of Birmingham
Patient story
For some participants like Ian, the benefits of receiving the new treatments tested as part of the trial have been significant.
Ian, who took part in the docetaxel and zoledronic acid arm of the trial said: “The diagnosis and the extent of the disease was very shocking for me. But to know that there was an opportunity to take part in a new treatment that was not normally available on the NHS was very positive.”
“There were several different treatment arms. When you take part, you are randomised and you don't know which of those treatments you're going to be given. It turned out that the chemotherapy group I was in was very beneficial - so I was pleased that I went through it because I knew there was a significant benefit.”
Having finished his course of chemotherapy as part of the trial, Ian was uncertain of his prognosis.
Ian said: “It's now more than five years now since I started treatment and I’m absolutely fit and healthy. So I'm really quite amazed that not only is my disease under control, but also having taken part on the trial - the knowledge gained has benefited thousands of other people.”
“I believe very strongly that if there's a way that you can help not only yourself, but other people as well - then if you’re given that opportunity you should take it. It wasn't a difficult decision for me.”
“For 70 years we were treating men with just hormonal manipulation. What STAMPEDE has shown is if we want the best outcomes - then we need to add additional treatments in. But the other way that this trial has been hugely beneficial is that it allowed us to say that certain drugs do not have a place up front for when men first present with their disease.”
Professor Andrew Protheroe, University of Oxford
To find out more, visit the STAMPEDE website.
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