STAMPEDE is a multi-centre, randomised controlled trial for
patients with locally advanced or metastatic prostate cancer who
are about to commence hormone therapy (HT). Patients can have
either newly diagnosed disease, or have been previously treated
with radical radiotherapy or surgery but now have a rising prostate
specific antigen (PSA). The trial will assess the effects of adding
two different agents, both as single agents and in combinations, to
hormone therapy.
A number of newer treatments have recently become available and
have shown initial promise against prostate cancer. Newer
treatments are usually used in prostate cancer when hormone
treatment is no longer effective and the cancer has started to grow
again. The aim of STAMPEDE is to assess newer treatments,
given earlier in the course of the disease in combination with
hormone treatment.
The new treatments being assessed are:
- Zoledronic acid: Prostate cancer cells can spread to bones and
weaken them. Zoledronic acid is a drug that reduces bone
destruction and hardens bones. This may make them more resistant to
attack by cancer cells.
- Docetaxel: A drug that stops cells replicating that is
currently being used to treat lung, breast and ovarian cancer.
- Abiraterone: A drug that works by blocking the
prostate cancer cells from making their own hormones.
STAMPEDE will look at the effect of combining one or two of the
new treatments described above with hormone treatment. A computer
program will be used to allocate which treatment the patient
receives, using a chance process. Two in every five patients will
receive hormone treatment only; the other three in five patients
will be split equally between the three newer combined treatment
options The trial will look at the effects of the combined
treatments on quality of life and find out whether the new
treatment combinations increase the time when the cancer is not
growing and result in patients living longer. The study will also
look at which treatment provides the greater value for money for
the health service. Between 2500 and 3500 patients will participate
in the trial and it will take between 6-10 years to
complete.
This trial uses a multi-arm, multi stage design which means that
the data is reviewed at planned interim analyses during the course
of the trial. After the last analysis at the end of March 2011 the
Trial Steering Committee decided to stop recruitment to arms D (HT
+ Celecoxib) and F (HT + Zoledronic Acid + Celecoxib) due to lack
of sufficient activity. Arms A, B, C and E were also reviewed and
continue unchanged.