Results of a phase I clinical trial of a novel herb-based therapeutic called Zyflamend have demonstrated that the therapy is associated with minimal toxicity and no serious adverse events in men at high-risk for developing prostate cancer.
The new findings, led by researchers from the Center for Holistic Urology at Columbia University Medical Center and NewYork-Presbyterian Hospital/Columbia, are published in the current issue of the Journal of the Society for Integrative Oncology.
In the study, 23 men ages 40-75 years-old who were diagnosed with high-grade prostatic intraepithelial neoplasia (HGPIN) at biopsy, lesions that indicate an increased risk of developing prostate cancer, were admitted into this prospective clinical trial, in order to determine the safety and tolerability of Zyflamend when administered orally for 18-months, either alone or along with various dietary supplements.
"Since we know that men with HGPIN have an increased risk for developing prostate cancer, new strategies formulated to decrease cancer risk, prevent or delay surgery, and improve quality of life, will be greatly beneficial for these men," said Aaron E. Katz, M.D., senior author of the study. He is associate professor of urology at Columbia University College of Physicians and Surgeons, director of the Center of Holistic Urology at Columbia University Medical Center and a urologist at NewYork-Presbyterian/Columbia.
Basic science studies have indicated that Zyflamend may have an anti-inflammatory mechanism of action and the agent has been shown to decrease prostate cancer proliferation in cell culture.
"Our results confirm that Zyflamend, in a dose of three times daily for up to 18-months, was well tolerated," said Jillian L. Capodice, M.S., director of the Acupuncture Research and Integrative Clinical Service of the Department of Urology's Center for Holistic Urology, at Columbia University College of Physicians and Surgeons.
Prostate cancer is a cancer that forms in tissues of the prostate (a gland in the male reproductive system found below the bladder and in front of the rectum). Prostate cancer usually occurs in older men. The National Cancer Institute estimates that in 2009 there will be 192,280 new cases of prostate cancer diagnosed and 27,360 deaths attributed to prostate cancer in the United States.
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