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A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer

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Trial Profile

A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Sipuleucel-T (Primary)
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Dendreon Corporation
  • Most Recent Events

    • 16 Feb 2019 Results of a pooled analysis of D9901, D9902A, and IMPACT trials assessing survival outcomes for African-American patients with mCRPC treated with sipuleucel-T, presented at the 2019 Genitourinary Cancers Symposium
    • 18 Feb 2017 Results of survival outcomes from three phase III studies including this study presented at the 2017 Genitourinary Cancers Symposium
    • 17 Sep 2013 Sipuleucel-T has been approved by the European Commission for the treatment of asymptomatic or minimally symptomatic, metastatic hormone-refractory prostate cancer. Approval was based on the results of this and 2 other trials.
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