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

As part of this research grant we have had encouraging results involving two smaller clinical studies, says Svend Freytag, Ph.D., division head of Research, Radiation Oncology, Henry Ford Hospital.

Dr. Freytag, along with Benjamin Movsas, M.D., chair of Radiation Oncology and Hans Stricker, M.D., vice chair of Urology at Henry Ford Hospital are the studys key researchers.

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

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

When you consider that across the world most trials involving gene treatment are in very early stages of development involving research in test tubes, the fact that Henry Ford Hospital is now embarking on a major phase III clinical trial to test this as a new standard therapy, is a testament to the world class innovative research taking place right here, says Dr. Movsas, principal investigator of the study. To my knowledge, this is the only place in the world where such a gene treatment study is available for this group of patients, he adds.

The first FDA-approved clinical trial studied approximately 15 men who previously had radiation treatment alone and experienced cancer regrowth. They were given only the suicide gene treatment, which was proven safe. Suicide gene treatment uses two specific genes, encased in a virus (the one linked to 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 treatment.

In this setting gene treatment 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 treatment. Since hormone treatment can be linked to a number of side effects, delaying the treatment can improve a patients quality of life.

The second trial of about 25 men with newly diagnosed prostate cancer combined the suicide gene treatment with radiation treatment. Again, it proved safe and demonstrated a benefit in a certain class of patients. Scientists observed that all of the patients with intermediate-risk prostate cancer (the group eligible for this study) had excellent responses following the combined therapy, 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 therapy for intermediate prostate cancer involving Intensity Modulated Radiation Therapy (IMRT), a high-precision radiation treatment 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 therapy involving the gene treatment with IMRT to see which therapy is most effective.


Posted by: Emily    Source

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