A team of University of Iowa Health Care researchers is conducting the next phase of a clinical trial that may lead to new treatments for men diagnosed with prostate cancer.
Researchers recently reported they have successfully completed a Phase I study of an adenovirus/prostate-specific antigen (Ad/PSA) vaccine for prostate cancer showing that the therapeutic agent can safely be given to patients.
A total of 32 men with advanced prostate cancer received a single dose of the vaccine in the study's initial phase in order to assess its safety. The treatment is not designed to prevent prostate cancer like a traditional vaccine prevents a disease. Instead, it stimulates the body's immune system to fight existing cancer cells.
The outcome of the study shows that the average survival time for patients in the study was 18 months, compared to the six to nine months that patients with such advanced disease typically survive. The study also shows evidence that the therapy did boost the patients' immune systems.
"The results of the Phase I portion of the trial are encouraging," said Richard Williams, MD, the Rubin H. Flocks Chair in Urology and professor and head of the UI Department of Urology. "Eventually, vaccines such as this may play an important role, in combination with other therapies, in the treatment of prostate cancer."
Following that positive result, the Food and Drug Administration gave approval for the UI researchers to begin Phase II of the trial. Several patients have already received treatment under the new segment of the study.
The UI researchers say it will take several years before the treatment could be approved and come into general use, if it is shown to be effective.
Other UI investigators involved in the study include:
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David Lubaroff, PhD, developer of the vaccine
- Badrinath Konety, MD
- Brian Link, MD
- Timothy Ratliff, PhD
- Tammy Madsen, PA
Prostate cancer is the third-leading cause of death among men in the United States. African-American males face a higher risk for the disease than other men.
Holden Comprehensive Cancer Center at the UI is Iowa's only National Cancer Institute (NCI)-designated comprehensive cancer center. NCI-designated comprehensive cancer centers are recognized as the leaders in developing new approaches to cancer prevention and cancer care, conducting leading edge research and educating the public about cancer.
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