SUMMARY: Sipuleucel-T (PROVENGE®) is a therapeutic cancer vaccine developed to boost the patients immune system to fight prostate cancer. In a double blind randomized phase III trial, 512 patients with metastatic castrate-resistant prostate cancer received PROVENGE® vaccine (341) or a placebo (171). There was a 4.1 month improvement in median survival for patients receiving the vaccine compared to those receiving a placebo (25.8 versus 21.7 months) and a 22% reduction in the risk of death in the vaccine group. Because of the slow onset of action of any vaccine therapy, this option may be appropriate for individuals with less aggressive disease. N Engl J Med 2010;363:411-422