Medical Therapy of Prostatic Symptoms (MTOPS)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00021814
First received: August 4, 2001
Last updated: January 12, 2010
Last verified: January 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

Publications:

ClinicalTrials.gov Identifier: NCT00021814     History of Changes
Other Study ID Numbers: MTOPS (completed), U01-DK-46472
Study First Received: August 4, 2001
Last Updated: January 12, 2010
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

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Hypertrophy
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Pathological Conditions, Anatomical
Finasteride
Doxazosin
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Urological Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014