Provenge® (sipuleucel-T), a type of immunotherapy, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of asymptomatic or minimally symptomatic, metastatic, hormone-refractory prostate cancer.

Prostate cancer is a hormonally sensitive disease that can be controlled for long periods with androgen-deprivation therapy (ADT). When prostate cancer stops responding to this treatment it is referred to as hormone-refractory. Metastatic, hormone-refractory prostate cancer is a challenging form of the disease to treat because the cancer has spread to distant sites in the body and does not respond to treatment with hormonal therapy.

Provenge is an immunotherapy that prompts the body’s immune system to respond against the cancer. A Phase III clinical trial that contributed to the approval of Provenge was a study known as IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment). The study enrolled 512 men with metastatic, hormone-refractory prostate cancer. Study participants were treated with either Provenge or a placebo. Median overall survival was 25.8 months in the Provenge group compared with 21.7 months in the placebo group.

The most common side effects of Provenge are chills, fatigue, fever, back pain, nausea, joint ache, and headache.

Initially, Provenge is expected to be made available at approximately 50 centers, all of which were approved Provenge clinical trial sites.


FDA News Release. FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer. Available at: Accessed April 29, 2010.

Kantoff P, Higano CS, Berger ER, et al. Updated survival results of the IMPACT trial of sipuleucel-T for metastatic castration-resistant prostate cancer (CRPC). Presented at the 2010 Genitourinary Cancers Symposium in San Francisco. March 5-7, 2010. Abstract #8.

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