STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy
A trial that aims to find the best treatment for people with advanced prostate cancer
What is this study about?
Prostate cancer accounts for around one fifth of all cancers among
men. In the UK there are around 25,000 new cases of prostate
cancer each year, and around 10,000 deaths.
Most men are given hormone therapy if their prostate cancer has spread
(metastasised), or if the cancer is very likely to spread.
This usually stops the tumour from growing for a while. But
in most cases over time the tumour will start to grow again.
The trial is testing how well four new drugs work to prevent the tumour from growing again. The drugs are called celecoxib, docetaxel, zoledronic acid and abiraterone acetate and are used alongside hormone therapy.
Who is included?
Men with newly diagnosed advanced prostate cancer, or with relapsing prostate cancer
When is it taking place?
Now until around 2014
Where is it taking place?
Hospitals throughout the UK and Switzerland.
Who is funding the study?
The trial is mainly funded by the charity Cancer Research UK with extra support from four pharmaceutical companies: Pfizer, Sanofi-Aventis,Novartis and Janssen.
|Type of study:||Randomised trial|
|MAMS||This is a multi arm multi stage study|
|Status:||Open to recruitment|
|Study start date:||October 2005|
|Study end date:||October 2014|
|Randomisations achieved:||2636, as of November 2011|
|Also included in this study:||Health Economics|
Quality of life outcomes
NHS Information Centre flagging
|Chief investigator:||Prof. Nick James|
|Registration numbers:||ISRCTN78818544, EUDRACT number: 2004-000193-31, CTA number: 00316/0026/001-0001, NCT number: NCT00268476|
|Inclusion criteria:||(1) High-risk newly diagnosed non-metastatic node-negative disease with at least two of: |
stage t3/4, psa>40ng/ml or gleason sum score 8-10
- intention to treat with radical radiotherapy (unless there is a contra-indication; exemption can sought in advance of consent, after discussion with MRC CTU.
(2) newly diagnosed metastatic or node-positive disease
- stage T(any) N+ M0 or T(any) N(any) M+1
(3) Previously treated with radical surgery or radiotherapy, now relapsing with least one of:
- PSA >4ng/ml and rising with doubling time less than 6 months
- PSA >20ng/ml
AND For all patients:-
(i) Histologically confirmed prostate adenocarcinoma
(ii) Intention to treat with long-term hormone therapy
(iii) Fit for all protocol treatment and follow-up, WHO performance status 0-2
(iv) Have completed the appropriate investigations prior to randomisation
(v) Adequate haematological function: neutrophil count >1.5x109/l and
(vi) Estimated creatinine clearance >30ml/min
(vii) Serum potassium >3.5mmol/L
(viii) Written informed consent
(ix) Willing and expected to comply with follow-up schedule
(x) Using effective contraceptive method if applicable
|Exclusion criteria:||(i) Prior systemic therapy for locally advanced or metastatic prostate cancer except as listed in inclusion criteria (3) |
(ii) Metastatic brain disease or leptomeningeal disease
(iii) Abnormal liver functions consisting of any of the following:
:: Serum bilirubin =1.5 x ULN (except for patients with Gilbert’s disease, for whom the
upper limit of serum bilirubin is 51.3Rmol/l or 3mg/dl)
:: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =2.5 x ULN
(iv) Any other previous or current malignant disease which, in the judgement of the responsible physician, is likely to interfere with STAMPEDE treatment or assessment
(v) Patients with active peptic ulceration, gastrointestinal bleeding, inflammatory bowel
(vi) Symptomatic peripheral neuropathy grade >2 (NCI CTC)
(vii) Any surgery (e.g. TURP) performed within the past 4 weeks
(viii) Patients with confirmed severe cardiovascular history e.g.:
a. Severe/unstable angina
b. Myocardial infarction
c. Severe cardiac failure (NYHA II-IV5)
d. Cerebrovascular disease (e.g. stroke or transient ischaemic episode)
e. Patients with uncontrolled hypertension defined as systolic BP >160 mmHg or diastolic BP >95 mmHg).
(ix) Patients who have been scheduled to have major dental extractions within the next 2 years
(x) Patients receiving treatment with drugs known to induce CYP3A4 (including phenytoin,
(xi) Prior exposure to abiraterone
(xii) Prior chemotherapy for prostate cancer
(xiii) Prior therapy with zoledronic acid other than short-term treatment for hypercalcaemia.
|Intervention and control groups:||Other|
|Method of randomisation:||Minimisation with random element|
|Study website:||http://www.stampedetrial.org |
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