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dc.contributor.authorJames, Nicholas D
dc.contributor.authorSydes, Matthew R
dc.contributor.authorClarke, Noel W
dc.contributor.authorMason, Malcolm D
dc.contributor.authorDearnaley, David P
dc.contributor.authorAnderson, John
dc.contributor.authorPopert, Richard J
dc.contributor.authorSanders, Karen
dc.contributor.authorMorgan, Rachel C
dc.contributor.authorStansfeld, J
dc.contributor.authorDwyer, John
dc.contributor.authorMasters, John
dc.contributor.authorParmar, Mahesh K B
dc.date.accessioned2009-06-04T09:23:58Z
dc.date.available2009-06-04T09:23:58Z
dc.date.issued2009-02
dc.identifier.citationSystemic therapy for advancing or metastatic prostate cancer (STAMPEDE): a multi-arm, multistage randomized controlled trial. 2009, 103 (4):464-9 BJU Int.en
dc.identifier.issn1464-410X
dc.identifier.pmid18990168
dc.identifier.doi10.1111/j.1464-410X.2008.08034.x
dc.identifier.urihttp://hdl.handle.net/10541/69696
dc.description.abstractThere 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.
dc.language.isoenen
dc.subjectProstate Canceren
dc.subjectZoledronic Aciden
dc.subjectRandomized Controlled Trialen
dc.subjectHormone Therapyen
dc.subjectDocetaxelen
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAged, 80 and over
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.meshDiphosphonates
dc.subject.meshHumans
dc.subject.meshImidazoles
dc.subject.meshMale
dc.subject.meshMiddle Aged
dc.subject.meshNeoplasm Metastasis
dc.subject.meshProstatic Neoplasms
dc.subject.meshPyrazoles
dc.subject.meshRisk Factors
dc.subject.meshSulfonamides
dc.subject.meshTaxoids
dc.subject.meshTreatment Outcome
dc.titleSystemic therapy for advancing or metastatic prostate cancer (STAMPEDE): a multi-arm, multistage randomized controlled trial.en
dc.typeArticleen
dc.contributor.departmentCRUK Institute for Cancer Studies, University of Birmingham, UK.en
dc.identifier.journalBJU Internationalen
html.description.abstractThere 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.


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