Can We Better Define the Patients that Benefit from Sipuleucel-T Treatment? - Editorial

It is now a decade ago that Provenge (sipuleucel-T), an autologous active cellular immunotherapy, was approved by the FDA. Many unanswered questions, still needed to be resolved. When to give this to which patient, i.e. timing and predictive patient characteristics are issues that need to be resolved.

An analysis of pooled phase III data suggested differences in overall survival (OS) between African American and Caucasian men receiving sipuleucel-T. This hypothesis was tested in a registry study (PROCEED, (NCT01306890)) in which 1900 patients were followed that received Sipuleucel-T treatment. Caucasian and African American men were compared after PSA matching, and the analysis showed that OS was longer in African Americans. This was particularly true when men were compared who started at lower PSA baseline levels.  The outcome from this registry, i.e. African American men treated early with Sipuleucel-T might benefit more warrants further studies to position this immunotherapy in the prostate cancer treatment landscape. The mechanism that would explain this difference is poorly understood yet also prompts further studies.

Written by: Jack Schalken, Ph.D., Director of Urological Research, Professor of Experimental Urology, Radboud University MC, Nijmegen, Netherlands


  1. Sartor O, Armstrong AJ, Ahaghotu C, et al. Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the PROCEED registry [published online February 28, 2020]. Prostate Cancer Prostatic Dis.
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Read the Full-Text Article: Survival of African-American and Caucasian Men after Sipuleucel-T Immunotherapy: Outcomes from the PROCEED Registry
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