Who is the trial Sponsor?
Medical Research Council.
How can a new centre join the trial?
To become a STAMPEDE centre, a represntaive should contact the
MRC CTU and provide the following information; Name and contacts
details for the principal investigator and person who will be
resonsible for the accreditaion process. Further details will then
be provided from there.
Are the trial drugs provided free of charge?
The zoledronic acid is provided free of charge from Novartis.
The docetaxel is provided at a discounted rate of buy 1 get 2 free
from Sanofi-Aventis. See the pharmacy section for further
details.
How is the drug supply ordered?
Zoledronic acid is ordered by the MRC CTU on behalf of
hospitals. Docetaxel must be ordered directly from
Sanofi-Aventis by the hospital Pharmacist. See the pharmacy section
for further details.
Is there any additional funding available?
The Department of Health has agreed to provide a subvention fund
of £1,787 per patient randomised to arms C or E of the trial and
prescribed docetaxel. See section 15 of the protocol for further
details.
Are patients eligible for the trial if they have already
started hormone therapy?
Yes, provided that the duration fo the hormone therapy is no
longer than 12 weeks before randomisation.
Are patients allowed to receive radiotherapy?
Yes, intention to treat with radiotherapy should be recorded at
randomisation. Radiotherapy should not start until at least 6
months after randomisation. See appendix P of the protocol for more
details.
How long are patients followed up for?
Patients should be seen for a follow up visit every 6 weeks for
24 weeks, then every 12 weeks until 2 years, every 6 months until 5
years and annually thereafter.
How is disease progression assessed?
Biochemically, clincically or symptomatically.
What is defined as a biochemical progesssion?
When patients reach week 24, the MRC CTU will issue a letter to
the investigator staitng the PSA nadir and PSA progession level for
that patient. If a patient reaches the PSA progession level stated
in this letter (whilst still on hormone therapy) and this is
confirmed by 2 separate readings then the patient is said to have
biochemically progressed. See Appendix K of the protocol for
further details.