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

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
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 November 19, 2008

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