Sipuleucel-T for the treatment of prostate cancer: novel insights and future directions

Future Oncol. 2018 Apr;14(10):907-917. doi: 10.2217/fon-2017-0531. Epub 2017 Dec 20.


Sipuleucel-T, an autologous cellular immunotherapy manufactured from antigen-presenting cells primed to recognize prostatic acid phosphatase, was the first immunotherapy product approved by the US FDA. It was approved for men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer after it was shown to provide a survival advantage. Additional studies have examined its use in other clinical settings and in combination with other approved and investigational immunotherapy agents. This review will discuss the pivotal trials leading to approval, will outline some of the biomarkers associated with its efficacy and will review some of the ongoing combination strategies. Maximizing the efficacy of sipuleucel-T through better patient selection or through combination approaches remains the challenge of the future.

Keywords: biomarkers; cancer vaccine; castration-resistant prostate cancer; immunotherapy; prostate cancer; sipuleucel-T.

Publication types

  • Review

MeSH terms

  • Acid Phosphatase
  • Animals
  • Antineoplastic Agents / therapeutic use
  • Biomarkers, Tumor
  • Cancer Vaccines / therapeutic use*
  • Clinical Trials as Topic
  • Combined Modality Therapy / trends
  • Humans
  • Immunotherapy, Adoptive / legislation & jurisprudence
  • Immunotherapy, Adoptive / trends*
  • Male
  • Prostatic Neoplasms, Castration-Resistant / therapy*
  • Tissue Extracts / adverse effects
  • Tissue Extracts / therapeutic use*


  • Antineoplastic Agents
  • Biomarkers, Tumor
  • Cancer Vaccines
  • Tissue Extracts
  • sipuleucel-T
  • Acid Phosphatase
  • prostatic acid phosphatase