Major recruitment milestone in
Recruitment to the “abiraterone comparison” of
STAMPEDE was completed on 17 January 2014, after the recruitment
target was reached. This is a major milestone for the trial because
the “abiraterone comparison” was the first of the new comparisons
to be incorporated into this ongoing multi-arm multi-stage trial.
Most trials have only two arms and do not change. STAMPEDE started
with 6 arms, and has efficiently drawn in further comparisons over
Rates of accrual to STAMPEDE were remarkable
throughout 2013 with an average of around 150 patients per month.
The recruitment target for the “abiraterone comparison” of 1800 men
with hormone-naïve prostate cancer was reached in 26 months instead
of the predicted 36 months.
The “abiraterone comparison” compares men
randomised over the same period of time to either the control group
(Arm A: standard care with androgen deprivation therapy with or
without radiotherapy) or the abiraterone group (Arm G: standard
care plus abiraterone and prednisone).
Recruitment to the abiraterone group started 5
years after the trial originally opened, but has been completed
only 10 months after completion of recruitment to the original
research arms. The original research arms assessed adding one or
two of zoledronic acid, docetaxel or celecoxib to standard
The primary outcome measure for all
comparisons is overall survival. Follow-up activity continues for
all trial patients. The results of the different comparisons within
STAMPEDE are eagerly awaited.
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 third new comparison,
the “enzalutamide + abiraterone comparison”, should start
recruitment in March with the initiation of Arm J. More information
More than 5,000 patients from across the UK
and Switzerland have joined STAMPEDE, demonstrating the
feasibility and benefits of conducting new comparisons within an
The STAMPEDE team would like to thank all of
the site staff and patients involved in the trial.