Alcohol Injection for BPH
Clinical Trial Initiated
Los Angeles, CA, March 19, 2001 --- In a press release today from American Medical Systems, the testing of direct alcohol injection as a treatment for men with symptomatic prostate enlargement was announced. The first men in this nationwide multicenter trial were treated in Los Angeles by Dr. Leonard Marks, Clinical Associate Professor of Urology at UCLA and Medical Director of Urological Sciences Research Foundation. The full press release is posted here.
Medicinal use of direct alcohol injection is not new and, in fact, was grandfathered onto the market for use in neurolysis when the Food, Drug and Cosmetic (FD&C) Act was enacted by Congress in 1938. It's also been successfully used for ablation of tumors. Now an application to prostate shrinkage for men with symptomatic BPH is being explored. The rationale for the project is detailed in the pioneering work of Prof. Goya and associates from Tokyo. The early U.S. work of Dr. Joseph Ditrolio has been presented in 1999 at the annual meeting of the American Urological Association and June, 2000 at the International Consultation on BPH in Paris; those abstracts are posted here.
An explanation of the procedure in a series of video clips is posted here. The procedure is done under a brief anesthetic procedure, generally involving a few minutes of cystoscopy time and a few hours of hospital stay. The study is being conducted in 13 medical centers across the U.S., including Stanford University, San Diego Naval Hospital, Columbia University, The Cleveland Clinic, and The University of Vermont.
A key advance in the present study is the use of a specially curved injection needle that allows more accurate delivery of the alcohol to the lobes of the prostate. The endoscopic needle, known as the Prostaject, is marketed exclusively by American Medical Systems of Minnetonka, MN, sponsor of the trial. The trial is being conducted under an IND (permit to investigate a new drug) reviewed by the U.S. Food and Drug Administration in January, 2001.
Patients interested in the alcohol injection project should call the offices of the Urological Sciences Research Foundation for further information, (310) 838-6347. Enrollment is expected to remain open through June, 2001.
Dr. Mark Plante, urology professor at the University of Vermont, works with Dr. Leonard Marks in the cystosopy suite during alcohol ablation of prostate. (click on image for description and larger version of picture)