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Feb. 7 - Research on Gene and Radiation Therapy for Prostate Cancer Expanded by Henry Ford Hospital

Henry Ford Hospital is embarking on an expanded major clinical trial involving the use of gene therapy in combination with radiation therapy, to determine if the combined treatment is more effective than radiation therapy alone for patients with intermediate risk prostate cancer.

The clinical trial is part of a $9 million grant from the National Cancer Institute (NCI) awarded to Henry Ford to study the effectiveness of gene therapy to treat prostate cancer.

Because of the results from the previous trials, NCI approved a phase III trial involving 280 prostate cancer patients over a three-year period. A phase III trial is the final stage in a study to determine if the treatment being studied should become the standard treatment.

Currently radiation therapy (without the gene therapy) or surgical removal of the prostate is the standard treatment for patients with localized prostate cancer, with similar cure rates. Prostate Cancer is the second leading cause of cancer death for men according to the American Cancer Society.

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 didn't 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 patient's 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.

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 which treatment is most effective.

Source: Henry Ford Health System

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