The pivotal IMPACT trial was a Phase 3, randomized, double-blind, multicenter, controlled study in 512 men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (CRPC).¹

Primary endpoint: Overall survival

Secondary endpoint: Time to objective disease progression

The main goal of the IMPACT trial was not to lower PSA levels—it was to extend survival.

Trial Design¹

*Eligible patients were hormone refractory and had metastatic disease in the soft tissue and/or bone with evidence of progression; 18% had received prior chemotherapy (including docetaxel).
^†Control was nonactivated, autologous, peripheral blood mononuclear cells.
^‡Progression=radiographic evidence of disease progression.
^§Autologous, peripheral blood mononuclear cells that were cryopreserved at the time of control generation and subsequently activated.

• 64% of patients in the control group, following progression, crossed over to a
  nonrandomized, open-label protocol to receive an investigational autologous
  immunotherapy made from cryopreserved cells¹
• Treatment in the open-label protocol was at the physician’s discretion

Phase 3 IMPACT Trial Results

Learn more about survival benefit with PROVENGE therapy, and read the complete
Phase 3 IMPACT Trial results published in the New England Journal of Medicine.

1. Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study Investigators.
   Sipuleucel-T immunotherapy for castrate-resistant prostate cancer. N Engl J Med.
   2010;363(5):411-422.