Sipuleucel-T (Provenge), an autologous cellular immunotherapy designed to stimulate a patient's own immune system against cancer, has been recently approved by the Food and Drug Administration (FDA) to treat asymptomatic or minimally symptomatic metastatic, "castration-resistant" (hormone-refractory) prostate cancer.

Provenge is made by collecting some of the patient's immune cells (in a process called leukapheresis) and then exposing them to a protein that will cause them to stimulate the immune system to work against the prostate cancer. The exposed cells are returned to the patient through IV infusion. A randomized, double-blind, placebo-controlled, multicenter clinical trial of 512 patients with metastatic, hormone-refractory prostate cancer found a small but statistically significant increase in overall survival of about four months among those who received Provenge.

Patient education should include a complete explanation of the procedure, which includes leukapheresis three days before infusion and three complete infusions, and the importance of keeping all scheduled appointments. (Skipping appointments will necessitate additional leukapheresis.) If venous access cannot be gained, a central venous catheter will be necessary.

Common adverse reactions include chills, fatigue, fever, back pain, nausea, joint ache, and headache. Most adverse effects are not severe, but acute infusion reactions and stroke have been among the severe reactions reported. For more information on sipuleucel-T from the FDA, go to http://bit.ly/bhfIRB.