Medical Therapy of Prostatic Symptoms (MTOPS) - Full Text View

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00021814

Purpose

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.

Condition	Intervention	Phase
Prostatic Hyperplasia Prostatic Hypertrophy, Benign	Drug: Doxazosin Drug: Finasteride	Phase III

Drug Information available for: Doxazosin Doxazosin mesylate Finasteride

U.S. FDA Resources

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

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment:	2931
Study Start Date:	December 1995
Estimated Study Completion Date:	March 1998

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021814

Locations

United States, California
University of California
La Jolla, California, United States, 92093-0694
United States, Colorado
Univ of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010-0510
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa Hospitals Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Henry Ford Health Systems
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Foundation
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63141
United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
New York University School of Medicine
New York, New York, United States, 10010
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232-2765
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 5235-9110
Baylor College of Medicine
Houston, Texas, United States, 77005
Brooke Army Medical Center
San Antonio, Texas, United States, 78234-6200

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

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

More Information

MTOPS public access site. Userid and password not required. This link exits the ClinicalTrials.gov site

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.

Study ID Numbers:	MTOPS, U01-DK-46472
Study First Received:	August 4, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00021814
Health Authority:	United States: Food and Drug Administration

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

BPH progression
Medical Therapy
Finasteride
Doxazosin
Randomized

Multi-center
Clinical Trial
Proscar
Cardura

Study placed in the following topic categories:

Finasteride
Pathological Conditions, Anatomical
Hypertrophy
Hyperplasia
Prostatic Diseases

Prostatic Hyperplasia
Disease Progression
Genital Diseases, Male
Doxazosin

Additional relevant MeSH terms:

Neurotransmitter Agents
Pathologic Processes
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Adrenergic Antagonists
Enzyme Inhibitors
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 30, 2009