Posted on March 22nd, 2010 by
The immunotherapy agent Provenge® (sipuleucel-T) significantly prolongs overall survival in men with metastatic, hormone-refractory prostate cancer, according to follow-up data presented at the 2010 Genitourinary Cancers Symposium in San Francisco.
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 be controlled for long periods with androgen deprivation therapy (ADT). When prostate cancer stops responding to this treatment is it referred to as hormone refractory prostate cancer. Metastatic, androgen-independent (or 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 investigational immunotherapy that is intended to prompt the body’s immune system to respond against the cancer. To evaluate the effect of Provenge among men with metastatic, androgen-independent prostate cancer, researchers conducted a Phase III clinical trial known as IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment). The trial enrolled 512 men. Study participants were treated with either Provenge or a placebo.
The median follow-up of this study is now 36.5 months. Researchers recently released updated data that continues to indicate that Provenge improves overall survival in this population of men. Median overall survival was 25.8 months in the Provenge group and 21.7 months in the group receiving placebo. The 36-month survival was 32% for the Provenge group versus 23% for the placebo group.
It is anticipated that these findings will result in FDA approval of Provenge.
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