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added 7/15/1997

Ann Arbor, MI - Could a vaccine to fight prostate cancer be on the horizon? A U-M researcher believes a new clinical trial using a combination of gene therapy and hormone therapy, now underway at the University of Michigan Medical Center, will go a long way toward answering that question.

Martin Sanda, M.D., assistant professor of Internal Medicine and Urology Surgery, has just begun a trial to test the efficacy of a vaccine for men in whom prostate cancer recurs after a radical prostatectomy.

The vaccine is a genetically engineered version of the small pox vaccine, called "prostvac." The test vaccine is created by extracting cancer cells during routine prostatectomy and inserting them into the small pox vaccine. The hope is that the vaccine will encourage the growth of T-lymphocyte cells that will recognize and kill the prostate cancer cells.

The Phase I/II study is one of three currently looking at the vaccine, but Sanda says the U-M trial is unique because it is targeting a vaccine at early stages of prostate cancer. "This is a novel approach to try and treat something in early disease before it has been evaluated in advanced forms," Sanda said. He points out that with advances in screening prostate cancer, most new cases are early forms of the disease, so it makes sense to target early treatment. Sanda hopes to enroll 21-to-24 men in the study.

Each patient must:

*Have had a radical prostatectomy -- a procedure to remove the prostate and some of the surrounding tissue.

*Be currently showing rising prostate-specific antigen (PSA) levels - which may indicate that the cancer is growing again.

*Have prostate cancer in an early enough stage to respond to hormone therapy, which uses various hormones to try and stop the growth of the cancer.

The patients will receive the vaccination one week after their last hormone therapy. They will then be tested weekly for the first 6-to-8 weeks and monthly after that. Sanda and his research team will measure PSA levels and look for tumor markers and lymphocyte response.

"The strategy," Sanda says, "is to improve and optimize a genetically engineered prostate cancer vaccine in patients who have tumors most likely to respond - that is, early and minimal tumors." Sanda says the main focus of this trial is to improve the efficacy of the vaccine. If the test vaccine shows promise, the next step would be to begin clinical trials to improve the vacci

The trial is funded by the American Cancer Society, The National Cancer Institute, CAP Cure and the Lilian Levy Foundation. Clinical services will be provided by the General Clinical Research Center here on the U-M campus.


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