August 11th, 2010

Provenge® for Hormone-refractory Prostate Cancer


Among men with metastatic, hormone-refractory prostate cancer, the immunotherapy agent Provenge® (sipuleucel-T) improves survival by roughly four months. The findings from this Phase III study were recently published in The New England Journal of Medicine.[1]

The prostate is a male sex gland responsible for producing fluid that forms semen. It is located below the bladder, in front of the rectum, and surrounds the urethra. Prostate cancer occurs when the cells in the prostate gland grow out of control.

Prostate cancer is a hormonally sensitive disease that can often 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 prostate cancer. 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 FDA approval of Provenge was a study known as IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment). The results of this study were presented at the 2010 Genitourinary Cancers Symposium, and the final results were recently published.[2]

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, a 4.1-month improvement in survival. The 36-month survival was 31.7% for the Provenge group versus 23% for the placebo group. Time to disease progression was similar in both groups. Chills, fever, and headache were reported more frequently in the Provenge group compared with the placebo group.

The four-month improvement in overall survival with manageable side effects reported in this study resulted in the approval of Provenge for the treatment of metastatic prostate cancer that is hormone-refractory.


[1] Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. New England Journal of Medicine. 2010;363:411-422.

[2] 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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