Medical Therapy of Prostatic Symptoms (MTOPS)

Condition(s) targeted: Prostatic Hyperplasia; Prostatic Hypertrophy, Benign

Intervention: Doxazosin (Drug); Finasteride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Official(s) and/or principal investigator(s):
E. David Crawford, Principal Investigator, Affiliation: Clinic 01 - Univ of Colorado Health Sciences Center
Steven A. Kaplan, Principal Investigator, Affiliation: Clinic 02 - New York Presbyterian Hospital
Claus Roehrborn, Principal Investigator, Affiliation: Clinic 03 - UT Southwestern Medical Center
Noah S. Schenkman, Principal Investigator, Affiliation: Clinic 04 - Walter Reed Army Medical Center
Herbert Lepor, Principal Investigator, Affiliation: Clinic 06 - New York University School of Medicine
Kevin M. Slawin, Principal Investigator, Affiliation: Clinic 07 - Baylor College of Medicine
John P. Foley, Principal Investigator, Affiliation: Clinic 08 - Brooke Army Medical Center
Joe W. Ramsdell, Principal Investigator, Affiliation: Clinic 09 - University of California San Diego
Mani Menon, Principal Investigator, Affiliation: Clinic 10 - Henry Ford Hospital
Michael M. Lieber, Principal Investigator, Affiliation: Clinic 11 - Mayo Foundation
Kevin T. McVary, Principal Investigator, Affiliation: Clinic 12 - Northwestern University
Joseph A. Smith, Principal Investigator, Affiliation: Clinic 13 - Vanderbilt University
Gerald L. Andriole, Principal Investigator, Affiliation: Clinic 14 - Washington University
Harris E. Foster, Principal Investigator, Affiliation: Clinic 15 - Yale University
Harry S. Clarke, Principal Investigator, Affiliation: Clinic 16 - Emory University
Karl J. Kreder, Principal Investigator, Affiliation: Clinic 17 - University of Iowa
Stephen C. Jacobs, Principal Investigator, Affiliation: Clinic 18 - University of Maryland
Gary J. Miller, Principal Investigator, Affiliation: Diagnostic Center - Univ of Colorado Health Sciences Center
Oliver M. Bautista, Principal Investigator, Affiliation: Biostatistical Coordinating Center - George Washington Univ.

The Medical Therapy of Prostatic Symptoms (MTOPS) is a clinical research study sponsored by the National Institutes of Health (NIH). The study will test whether the oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or together, can delay or prevent further worsening of symptoms in men with Benign Prostatic Hyperplasia (BPH).

MTOPS is the largest and longest study to simultaneously test whether these drugs can delay or prevent the clinical progression (symptom worsening) of BPH. Seventeen U. S. medical centers recruited 2,931 men diagnosed with symptomatic BPH between December 1995 and March 1998. Study doctors will continue to follow these men through November 2001 on a quarterly basis. In addition to the clinical progression of BPH, MTOPS will include evaluations of prostate volume by ultrasound, prostate biopsies among a subgroup of volunteers, and quality of life.

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Peak urinary flow rate at least 4 ml/sec but not greater than 15 ml/sec; and voided

volume is at least 125 ml.

- American Urological Association Symptom Score is greater than or equal to 8 and less

than or equal to 30.

- Voluntarily signed the informed consent agreement prior to the performance of any

study procedures.

Exclusion Criteria:

- Serum prostate specific antigen level greater than 10 ng/ml.

- Supine blood pressure less than 90/70 mmHG. Orthostatic hypotension.

- Any prior medical or surgical intervention for BPH.

- Received any prior experimental intervention (either medical or surgical) for prostate

disease or enrolled in any other study protocol.

University of California, La Jolla, California 92093-0694, United States

Univ of Colorado Health Sciences Center, Aurora, Colorado 80010-0510, United States

Yale University, New Haven, Connecticut 06520, United States

Walter Reed Army Medical Center, Washington, District of Columbia 20307, United States

Emory University, Atlanta, Georgia 30322, United States

Northwestern University, Chicago, Illinois 60611, United States

University of Iowa Hospitals Clinics, Iowa City, Iowa 52242, United States

University of Maryland, Baltimore, Maryland 21201, United States

Henry Ford Health Systems, Detroit, Michigan 48202, United States

Mayo Foundation, Rochester, Minnesota 55905, United States

Washington University, St. Louis, Missouri 63141, United States

Columbia Presbyterian Medical Center, New York, New York 10032, United States

New York University School of Medicine, New York, New York 10010, United States

Vanderbilt University, Nashville, Tennessee 37232-2765, United States

UT Southwestern Medical Center, Dallas, Texas 5235-9110, United States

Baylor College of Medicine, Houston, Texas 77005, United States

Brooke Army Medical Center, San Antonio, Texas 78234-6200, United States

MTOPS public access site. Userid and password not required.

Related publications:

Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age. J Urol. 1984 Sep;132(3):474-9.

Sidney S, Quesenberry CP Jr, Sadler MC, Guess HA, Lydick EG, Cattolica EV. Incidence of surgically treated benign prostatic hypertrophy and of prostate cancer among blacks and whites in a prepaid health care plan. Am J Epidemiol. 1991 Oct 15;134(8):825-9.

Gormley GJ, Stoner E, Bruskewitz RC, Imperato-McGinley J, Walsh PC, McConnell JD, Andriole GL, Geller J, Bracken BR, Tenover JS, et al. The effect of finasteride in men with benign prostatic hyperplasia. The Finasteride Study Group. N Engl J Med. 1992 Oct 22;327(17):1185-91.

Lepor H, Gup DI, Baumann M, Shapiro E. Laboratory assessment of terazosin and alpha-1 blockade in prostatic hyperplasia. Urology. 1988 Dec;32(6 Suppl):21-6.

Lepor H, Henry D, Laddu AR. The efficacy and safety of terazosin for the treatment of symptomatic BPH. Prostate. 1991;18(4):345-55. Review.

Guess HA. Benign prostatic hyperplasia: antecedents and natural history. Epidemiol Rev. 1992;14:131-53. Review. No abstract available.

McConnell JD. Androgen ablation and blockade in the treatment of benign prostatic hyperplasia. Urol Clin North Am. 1990 Aug;17(3):661-70. Review.

Barry MJ. Epidemiology and natural history of benign prostatic hyperplasia. Urol Clin North Am. 1990 Aug;17(3):495-507. Review.

Mebust WK, Holtgrewe HL, Cockett AT, Peters PC. Transurethral prostatectomy: immediate and postoperative complications. A cooperative study of 13 participating institutions evaluating 3,885 patients. J Urol. 1989 Feb;141(2):243-7.

Starting date: December 1995
Ending date: March 1998
Last updated: June 23, 2005