Systemic therapy for advancing or metastatic prostate cancer (STAMPEDE): a multi-arm, multistage randomized controlled trial.
Authors
James, Nicholas DSydes, Matthew R
Clarke, Noel W
Mason, Malcolm D
Dearnaley, David P
Anderson, John
Popert, Richard J
Sanders, Karen
Morgan, Rachel C
Stansfeld, J
Dwyer, John
Masters, John
Parmar, Mahesh K B
Affiliation
CRUK Institute for Cancer Studies, University of Birmingham, UK.Issue Date
2009-02
Metadata
Show full item recordAbstract
There is a need to improve the outcomes for men with high-risk localised, nodal or metastatic prostate cancer, or with aggressively relapsing disease after initial therapy for local disease. This group of men is currently managed with long-term hormone therapy. Thus we aim to evaluate the toxicity and efficacy of three different systemic therapies (docetaxel, zoledronic acid and celecoxib) used alone or combined at the initiation of hormone manipulation for high-risk prostate cancer. A novel statistical design (multi-arm, multistage method) simultaneously tests multiple distinct strategies in parallel against a single control arm. The trial has several 'stages', from initial confirmation of safety to a phase III assessment of survival, with a series of intervening activity stages. This method provides a means of assessing several agents more quickly and efficiently, and allows inactive treatments to be dropped from further study at an early stage. STAMPEDE has been designed to address in parallel the activity and efficacy of these agents for this patient group. It is a flagship randomized clinical trial for academic research into prostate cancer in the UK. More than 500 patients have been recruited on schedule, confirming the acceptability of this complex trial design to patients and clinicians. The trial targets a population of approximately 3000 patients. STAMPEDE is a major new trial with a novel design applicable to the synchronous testing of several agents. It is hoped that the results will improve outcomes for patients with high-risk prostate cancer. The design could be applicable to the study of new therapies in other cancer types. Continued efforts are required by the urological cancer community to maintain the excellent recruitment shown to date.Citation
Systemic therapy for advancing or metastatic prostate cancer (STAMPEDE): a multi-arm, multistage randomized controlled trial. 2009, 103 (4):464-9 BJU Int.Journal
BJU InternationalDOI
10.1111/j.1464-410X.2008.08034.xPubMed ID
18990168Type
ArticleLanguage
enISSN
1464-410Xae974a485f413a2113503eed53cd6c53
10.1111/j.1464-410X.2008.08034.x
Scopus Count
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