More than 1 million Americans have
prostate cancer, the leading non-skin cancer in men in the United
States. Last year alone some 220,000 new prostate cancer cases were
reported, and 28,900 men died of it.
The UC study, headed by R. Bruce Bracken,
MD, professor of surgery in the Division of Urology, is testing the
effectiveness of a new, experimental vaccine called Provenge, designed
to trigger a patient's own immune system to seek out and destroy cancer
cells. The year-long trial will determine whether the vaccine slows the
progression of prostate cancer and the development of disease-related
Study participants all have an advanced
condition known as "androgen-independent" prostate cancer, meaning
their male hormone (androgen) levels have been depressed by earlier,
but unsuccessful hormone therapy.
Depending on the seriousness of the
condition, standard treatments for prostate cancer include surgery,
radiation, and hormone and chemotherapy. A relatively new approach,
vaccines are used when localized treatment, such as radiation seeding,
The results of the UC study could help determine whether Provenge receives approval.
To participate in the study, men must
have prostate cancer that has "metastasized," or spread, during hormone
therapy. They must also have a Gleason score, the standard measure of
the seriousness of prostate cancer, of seven or lower and have no
current cancer-related pain.
The safety and effectiveness of Provenge,
Dr. Bracken points out, are not yet fully established. It might not
benefit the patient and could also cause severe or even
life-threatening side effects.