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WSU School of Medicine researchers test vaccine to treat advanced prostate cancer

DETROIT – March 3, 2004 – Richard Santucci, M.D., assistant professor of urology at the Wayne State University School of Medicine, is conducting a clinical research trial of an investigational product for metastatic prostate cancer. The vaccine, called Provengeâ, is designed to trigger a patient's own immune system to seek out and destroy cancer cells.

Currently, Dr. Santucci is enrolling men in the Phase 3 placebo-controlled clinical trial who have androgen-independent prostate cancer with a Gleason Score of 7 or below and bone or soft tissue metastases. The WSU School of Medicine is the only site in Michigan conducting the study.

"This investigational vaccine is designed to use a patient’s own cells to fight against prostate cancer. This trial is currently enrolling men with advanced prostate cancer who currently have limited therapeutic treatments available," said Dr. Santucci.

To be eligible for the study, men must have metastatic prostate cancer that has progressed while on hormone therapy. Patients must also have a Gleason Score of 7 or lower, have no current cancer-related pain and meet certain other eligibility criteria. For information on the trial, call 1-866-4-PROSTATE (1-866-477-6782).

The safety and effectiveness of Provenge^® have not yet been fully established. As with other anti-cancer treatments, this investigational treatment may not provide benefit and may cause side effects. These side effects could be severe or even life-threatening. There may be side effects that are not known or predictable at this time, but that may occur at the time of treatment or later.

Gleason Score is considered one of the most important prognostic indicators for prostate cancer. The score is based on the examination of a patient’s prostate cancer tissue and correlates with the aggressiveness of the tumor. In the metastatic, androgen independent patient population, approximately 75 to 80 percent of patients have cancer with a Gleason Score of 7 or less.

Prostate cancer is the leading non-skin cancer diagnosed among men in the United States. More than one million men in the United States have prostate cancer, with an estimated 220,000 cases diagnosed and 28,900 deaths in 2003. There are currently no products FDA-approved for slowing or stopping the progression of AIPC or delaying the onset of cancer-related pain.

With more than 1,000 medical students, WSU is among the nation’s largest medical schools. Together with its clinical partner, the Wayne State University Physician Group, the school is a leader in patient care and medical research in a number of areas, including cancer, genetics, neuroscience and women’s and children’s health.

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