Results of phase I trial of novel herbal therapy for men at high risk of prostate cancer

NEW YORK – 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.

NewYork-Presbyterian Hospital, based in New York City, is the nation's largest not-for-profit, non-sectarian hospital, with 2,242 beds. The Hospital has nearly 2 million inpatient and outpatient visits in a year, including more than 230,000 visits to its emergency departments — more than any other area hospital. NewYork-Presbyterian provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian Morgan Stanley Children's Hospital, NewYork-Presbyterian Hospital/The Allen Pavilion and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons. For more information, visit www.nyp.org.

Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians & Surgeons was the first institution in the country to grant the M.D. degree. Among the most selective medical schools in the country, the school is home to the largest medical research enterprise in New York State and one of the largest in the country. For more information, visit www.cumc.columbia.edu.