The STAMPEDE trial

Paradigm-changing data through innovative trial design

Bradley C. Carthon, Emmanuel Antonarakis

Research output: Contribution to journalArticle

Abstract

Despite the numerous regulatory approvals for prostate cancer, metastatic prostate cancer remains a huge burden for men worldwide. In an exciting development, James et al. recently published data from the Systemic Therapy in Advanced or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: a multi-stage multi-arm randomised control trial (STAMPEDE). This is an innovative multi-arm multi-stage (MAMS) trial that has utilized one control arm and several comparator arms in order to provide evidence for the inclusion of therapies beyond standard androgen deprivation alone. The patient population included: (I) men with high-risk, non-metastatic, node-negative disease; (II) men with distant-metastatic or node-positive disease; and (III) men with previously-treated prostate cancer by prostatectomy or definitive radiotherapy presenting with relapse. Men were to continue androgen deprivation for at least 2 years. The current data published by this group supports earlier results and provides additional evidence that docetaxel utilized in an up-front fashion provides a survival benefit in men with hormone-sensitive metastatic prostate cancer. Moreover, the initial results from STAMPEDE show how therapies without a demonstrated survival benefit can be efficiently excluded from further study once the likelihood of a benefit is ruled out by a predetermined analysis. In this piece, we will review the STAMPEDE data, contrast it with existing results, and provide our perspectives on how this will affect future trial conduct in the field of prostate cancer.

Original languageEnglish (US)
Pages (from-to)S485-S490
JournalTranslational Cancer Research
Volume5
DOIs
StatePublished - 2016

Fingerprint

Prostatic Neoplasms
docetaxel
Androgens
Drug Evaluation
Survival
Prostatectomy
Radiotherapy
Therapeutics
Hormones
Recurrence
Population

Keywords

  • Androgen deprivation
  • Docetaxel
  • Stampede
  • Zoledronic acid

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

The STAMPEDE trial : Paradigm-changing data through innovative trial design. / Carthon, Bradley C.; Antonarakis, Emmanuel.

In: Translational Cancer Research, Vol. 5, 2016, p. S485-S490.

Research output: Contribution to journalArticle

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