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| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
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Stampede
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Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy
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Topic
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Cancer
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Portfolio Eligibility
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Funded by UKCRC partner
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ISRCTN
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78818544
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EudraCT
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2004-000193-31
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MREC N° |
04/MRE07/35
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UKCRN ID |
1409
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WHO ID
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Research Summary
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Added as of 11/09/2008:
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 three new drugs work to prevent the tumour from growing again. The drugs are called celecoxib, docetaxel and zoledronic acid and are used with the hormone therapy.
The trial information can also be found at the following MRC CTU web page: http://www.ctu.mrc.ac.uk/studies/pr08.asp
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Study Type |
Interventional
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Design Type |
Treatment
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Disease(s) |
Prostate
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Phase |
II/III
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Current Status
| Open |
| Closure Date | 31/10/2013 |
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Sample Size
| 3300 |
| Accrual to Date |
 50% |
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Geographical Scope
| UK Multi-Centre |
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Lead Country
| England (also active in Scotland and Northern Ireland and Wales) |
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Open to new sites
| Yes, within and outside lead country |
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Main Inclusion Criteria
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Patients must fulfil one of the inclusion criteria in section 1 or one the inclusion criteria in section 2. Additionally, all patients must fulfil the inclusion criteria in section 3.
Section 1. High risk newly diagnosed patients must fulfil one of the following criteria -
(a) Stage T3/4 N0 M0 histologically confirmed prostate adenocarcinoma with PSA >= 40ng/ml or Gleason sum score 8-10.
(b) Stage T(any) N+ M0 or T(any) N(any) M+ histologically confirmed prostate adenocarcinoma
(c) Multiple sclerotic bone metastases with a PSA >= 100ng/ml and no histological confirmation of Pca
Section 2. Patients with histologically confirmed prostate adenocarcinoma previously treated with radical surgery or radiotherapy that are now relapsing (please note that prior hormone therapy for localised disease must have been completed 12 months previously, have been no longer than 12 months in duration and given as adjuvant or neoadjuvant therapy):
(a) PSA = 4ng/ml and rising with doubling time less than 6 months or
(b) PSA = 20ng/mlSection 3.
For all patients-
(a) Intention to treat with long-term androgen suppression
(b) Fit for all protocol treatment and follow-up, WHO performance status 0-2
(c) Have completed the appropriate investigations prior to randomisation
(d) Adequate haematological function: neutrophil count >1.5x109/l and platelets >100x109/l
(e) Adequate renal function: Serum creatinine <1.5 ULN
(f) Adequate liver function: ALT or AST <1.5 ULN, bilirubin (g) Normal testosterone level prior to treatment
(h) Written informed consent
(i) Willing and expected to comply with follow-up schedule
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Main Exclusion Criteria
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Section 4. For all patients-
(a) Prior systemic therapy for locally advanced or metastatic prostate cancer except as listed in Section 2.
(b) Metastatic brain disease or leptomeningeal disease
(c) Any other previous or current malignant disease which, in the judgement of the responsible physician, is likely to interfere with STAMPEDE treatment or assessment
(d) Symptomatic peripheral neuropathy grade 2 (NCI CTC)
(e) Any surgery (e.g. TURP) performed within the past 4 weeks
(f) Renal insufficiency with estimated creatinine clearance <30ml/min.
(g) Patients who have been on a cox-2-inhibitor for at least 6 months prior to trial entry
(h) Patients with confirmed cardiovascular history including:
(i) Severe/unstable angina
(ii) Myocardial infarction
(iii) Severe cardiac failure (NYHA II-IV*)
(iv) Cerebrovascular disease (e.g. stroke or transient ischemic episode)
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Chief Investigator(s)
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| Prof Nicholas James |
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Further details, please contact
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Miss Karen Sanders
Medical Research Council
Cancer Division
222 Euston Road
London
NW1 2DA
UNITED KINGDOM
Tel: 0207 670 4831
kas@ctu.mrc.ac.uk
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Funder(s) |
Cancer Research UK
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Sponsor(s) |
Medical Research Council
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