Date: February 26, 1996
For Release: Immediate
Contact: NIDDK/Mary Harris or Jane DeMouy (301) 496-6110

PROSTATE DISEASE TRIAL TO STUDY 3,000

The largest and longest study to test whether drugs can stop noncancerous prostate growth is recruiting 3,000 men at 17 centers, the National Institutes of Health (NIH) announced today.

The Medical Therapy of Benign Prostatic Hyperplasia (BPH) Trial will test 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 the New York City.

Untreated, prostate enlargement can lead to urinary tract infections, urinary retention, and, in rare cases, kidney disease.

Men can call toll-free 1-800-BPH-1221 to locate the nearest participating medical center.

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.

A complete news kit is available from (301) 496-6110.

For Interviews

Study Spokespersons

Leroy N. Nyberg, Ph.D., M.D. (301) 594-7717
Director, Urology Program
Division of Kidney, Urologic,
and Hematologic Diseases

Gary E. Striker, M.D. (301) 496-6325
Director
Division of Kidney, Urologic,
and Hematologic Diseases

John D. McConnell, M.D. (214) 648-4767
BPH Trial Chairman
Chairman, Division of Urology
University of Texas Southwestern Med. Ctr.

Gerald L. Andriole, M.D. (314) 362-8212
BPH Trial Physician
Washington University, St. Louis

Reginald C. Bruskewitz, M.D. (608) 263-9534
BPH Trial External Advisory Board
University of Wisconsin, Madison

Pharmaceutical Concerns

Merck & Co. (finasteride, Proscar )
Glenn Gormley, M.D., Ph.D. (908) 594-4103

Pfizer Inc (doxazosin, Cardura )
Richard Siegel, M.D. (212) 573-2798
Additional Resources

National Kidney and Urologic Diseases

Information Clearinghouse

3 Information Way
Bethesda, Maryland 20892-3580
(A service of the National Institute of

Diabetes and Digestive and Kidney Diseases)

Prostate Health Council
American Foundation for Urologic Disease Suite 401
300 West Pratt Street
Baltimore, Maryland 21201-2463
(410) 727-2908

Agency for Health Care Policy and Research Publications Clearinghouse
P.O. Box 8547
Silver Spring, Maryland 20907
(800) 358-9295
(Clinical Practice Guideline:
For Patients--Treating Your Enlarged Prostate: Benign Prostatic Hyperplasia Patient Guide
For Physicians--Benign Prostatic Hyperplasia: Diagnosis and Treatment; and Quick Reference Guide for Clinicians)

National Institute on Aging
Information Center
P.O. Box 8057
Gaithersburg, Maryland 20898-8057
(800) 222-2225
(Age Page: Prostate Problems)

Voluntary Groups

American Prostate Association
P.O. Box 4206
Silver Spring, Maryland 20914
(301) 384-9405

American Prostate Society
1340 Charwood Road

California
University of California, San Diego
Physician: Joe W. Ramsdell, M.D. (619) 597-2640 Study Coordinator: Zana G. Parman, B.A. (619) 597-2640 Public Affairs: Nancy Stringer (619) 543-6163

Colorado
University of Colorado Health Sciences Center, Denver Physician: E. David Crawford, M.D. (303) 270-5936 Study Coordinator: Kevin Homan, R.N. (303) 399-8020, ext. 3535 Public Affairs: Hillarie Portell (303) 270-5571

Connecticut
Yale University School of Medicine, New Haven, Connecticut Physician: Harris E. Foster, M.D. (203) 785-2815 Study Coordinator: Theresa Martin, R.N. (203) 737-1676 Public Affairs: Katherine Zaurski (203) 785-2490

Washington, D.C.
Walter Reed Army Medical Center
Physician: David G. McLeod, M.D., J.D. (202) 782-3867 or 782-6408
Study Coordinator: Dorothy V. Myers, R.N., M.S.N. (202) 782-4682
Public Affairs: Ben Smith (202) 782-7177 or 782-7131

Georgia
Emory University, Atlanta, Georgia
Physician: Harry S. Clarke, M.D., Ph.D. (404) 778-4898 Study Coordinator: Beverly J. Lopez, R.N. (404) 778-4162 Public Affairs: Sarah Goodwin (404) 727-3366

Illinois
Northwestern University Medical School, Chicago Physician: Kevin T. McVary, M.D. (312) 908-1987 or (312) 908-8600
Study Coordinator: Elsie Perez (312) 908-7026 Public Affairs: Elizabeth Crown (312) 503-8928

Iowa
University of Iowa Hospitals & Clinics Physician: William A. See, M.D. (319) 356-3517 Study Coordinator: Margery Fearing, A.P.N. (319) 355-8666 Public Affairs: Vera Dordick (319) 335-6660

Maryland
University of Maryland Medical System, Baltimore Physician: Stephen C. Jacobs, M.D. (410) 328-2048 Study Coordinator: Mary Hershner, R.N. (410) 328-0801 Public Affairs: Ellen Beth Levitt (410) 328-8919

Michigan
Henry Ford Hospital, Detroit, Michigan
Physician: Aaron K. Kirkemo, M.D. (313) 876-7660 Study Coordinator: Michelle Fedon, R.N., B.S.N., C.U.R.N. (313) 556-8265
Public Affairs: Claudia Freeman (313) 874-4692

Minnesota
Mayo Foundation, Rochester
Physician: Michael M. Lieber, M.D. (507) 284-3369 Study Coordinator: Karen A. Hanson, R.N., C.U.R.N. (507) 284-3369
Public Affairs: Lewis Porter (507) 284-4371

Missouri
Washington University, St. Louis
Physician: Gerald L. Andriole, M.D. (314) 362-8212 Study Coordinator: Becky Snider, R.N. (314) 576-4697 Public Affairs: Caroline Decker (314) 362-8642

New York
Columbia Presbyterian Medical Center, New York City Physician: Steven A. Kaplan, M.D. (212) 305-0146 or (215) 305-0140
Study Coordinator: Patricia Meade-D'Alisera, R.N. (212) 305-0146 or (212)
305-0140
Public Affairs: Karen Eskenazi (212) 305-5587

New York University School of Medicine
Physician: Herbert Lepor, M.D. (212) 263-6301 Study Coordinator: Jean Feser, C.U.R.N. (212) 686-7500, ext. 4265
Public Affairs: Lyn O'dell (212) 263-5800

Tennessee
Vanderbilt University, Nashville
Physician: Joseph A. Smith, Jr., M.D. (615) 322-2142 Study Coordinator: Brenda Hughes, R.N. (615) 322-2142 Public Affairs: Doug Williams (615) 322-4747

Texas
Baylor College of Medicine, Houston
Physician: Kevin M. Slawin, M.D. (713) 798-8670 Study Coordinator: Valory Pavlik, Ph.D., M.P.H. (713) 798-4906 Public Affairs: Ron Ozio (713) 798-4712

Brooke Army Medical Center, Fort Sam Houston Physician: Ian M. Thompson, M.D. (210) 916-6163 Study Coordinator: Catherine R. Pollard (210) 916-6581 Public Affairs: Ms. Arcy Longoria (210) 916-8437

University of Texas Southwestern Medical Center, Dallas Physician: Claus Roehrborn, M.D. (214) 648-2941 Study Coordinator: Sherril Brown, R.N., B.S.N. (214) 648-7959 Public Affairs: Jennifer Donovan (214) 648-3404