The largest and longest study to test whether drugs can stop the noncancerous prostate growth known as benign prostatic hyperplasia or BPH is recruiting 3,000 men at 17 centers, the National Institutes of Health (NIH) announced today.
The Medical Therapy of Prostatic Symptoms (MTOPS) Trial is testing whether the oral drugs finasteride (Proscar) and doxazosin (Cardura) will prevent further growth of the prostate that might require more expensive treatment such as surgery.
The U.S. Food and Drug Administration approved finasteride in 1992 and doxazosin in 1995 to relieve the symptoms of BPH. "These drugs can relieve the symptoms in many men over the short term. But we don't know if they only postpone, or can actually prevent, the need for surgery or other treatment down the road," says John McConnell, M.D., a urologist at the University of Texas Southwestern Medical Center in Dallas and chairman of the study.
By age 60, more than one-half of all men, and eventually most men, will have BPH, which causes frequent and urgent calls to urinate. Once they reach a bathroom, men with BPH may have trouble starting the urine flow, may have a weak or interrupted stream, and may dribble after they think their bladder is empty.
BPH is an expensive disease. About 7.5 million men have BPH, with about 250,000 men needing prostate surgery each year. All forms of treatment for BPH cost an estimated $5 billion each year, and as the U.S. population ages, these costs will increase.
"By the year 2000, the number of men over 50 will have increased by 25 percent, and we estimate that about 9 million men will have symptoms of BPH," says Steven Kaplan, M.D., a trial physician at Columbia Presbyterian Medical Center in New York City.
Untreated, prostate enlargement can lead to urinary tract infections, urinary retention, and, in rare cases, kidney disease.
The BPH Trial is supported by the National Institutes of Health's National Institute of Diabetes and Digestive and Kidney Diseases and the Office of Research on Minority Health; Pfizer Inc., New York City; and Merck & Co., Rahway, New Jersey.
Additional Resources:
Agency for Health Care Policy and Research
Publications Clearinghouse
P.O. Box 8547
Silver Spring, MD 20907
(800) 358-9295
E-mail: info@ahcpr.gov
(Clinical Practice Guideline:
For Patients--Treating Your Enlarged Prostate Patient Guide
For Physicians--Benign Prostatic Hyperplasia: Diagnosis and Treatment
American Prostate Society
7188 Ridge Rd.
Hanover, MD 21076
(410) 859-3735
National Institute on Aging
Information Center
P.O. Box 8057
Gaithersburg, MD 20898-8057
(800) 222-2225
E-mail: niainfo@lkacc.com
Age Page: Prostate Problems
National Kidney and Urologic Diseases Information Clearinghouse
3 Information Way
Bethesda, MD 20892-3580
E-mail: nkudic@info.niddk.nih.gov
Prostate Enlargement: Benign Prostatic Hyperplasia
Prostate Health Council
American Foundation for Urologic Disease
Suite 401
300 West Pratt Street
Baltimore, MD 21201-2463
(410) 727-2908
# # #
CONTACT:
Mary Harris
Jane DeMouy
National Institute of
Diabetes and Digestive
and Kidney Diseases
(301) 496-3583
