Medical Therapy of Prostatic Symptoms (MTOPS) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Medical Therapy of Prostatic Symptoms (MTOPS)

Official Title ^†

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Prostatic Hyperplasia
Prostatic Hypertrophy, Benign

Intervention ^†

Drug: Doxazosin
Drug: Finasteride

MEDLINE PMIDs

6206240, 1719806, 1383816, 2462301, 1711689, 1283852, 1695786, 1695778, 2643719

Links

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

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

2931

Start Date ^†

December 1995

Completion Date

March 1998

Eligibility 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.

Gender

Male

Ages

50 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00021814

Organization ID

MTOPS

Secondary IDs ^††

U01-DK-46472

Study Sponsor ^†

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

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.

Information Provided By

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

Verification Date

July 2003

First Received Date ^†

August 4, 2001

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.