Henry Ford Hospital expands research on gene and radiation therapy for prost...(p of patients he adds. The first FDA...),Health

The first FDA-approved clinical trial studied approximately 15 men who previously had radiation therapy alone and experienced cancer regrowth. They were given only the suicide gene therapy, which was proven safe. Suicide gene therapy uses two specific genes, encased in a virus (the one associated with the common cold), to convert non-toxic drugs into highly toxic agents when the genes are inserted into a tumor. The genes activate chemotherapeutic agents locally to destroy the cancer cells and make them more sensitive to enhance the effectiveness of radiation therapy.

In this setting gene therapy didnt eliminate the cancer, but it did slow its rate of growth and delayed by an average of 2.5 years, when the patients began hormone therapy. Since hormone therapy can be associated with many side effects, delaying the therapy can improve a patients quality of life.

The second trial of about 25 men with newly diagnosed prostate cancer combined the suicide gene therapy with radiation therapy. Again, it proved safe and demonstrated a benefit in a certain class of patients. Researchers found that all of the patients with intermediate-risk prostate cancer (the group eligible for this study) had excellent responses following the combined treatment, with no evidence of cancer regrowth to date.

The main criteria for the phase III study requires either a patients PSA to be in the range of 10-20 and/or a Gleason score of 7 (moderately differentiated tumor cells on the prostate biopsy).

In this randomized study, half of the patients will received the standard treatment for intermediate prostate cancer involving Intensity Modulated Radiation Therapy (IMRT), a high-precision radiation therapy technique uses computer-controlled x-ray beams so that the radiation delivery conforms to the shape of the tumor.

The other half will receive the combination treatment involving the gene therapy with IMRT to see
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