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Date: February 26, 1996 For Release: Immediate Contact: NIDDK/Mary Harris or Jane DeMouy (301) 496-6110
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 Hanover, Maryland 21076 (410) 859-3735 NIDDK BPH Trial Clinical Centers 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