Medical Therapy of Prostatic Symptoms

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.

Conditions

• Prostatic Hyperplasia
• Prostatic Hypertrophy, Benign

Interventions

DRUG

Doxazosin

DRUG

Finasteride

DRUG

Doxazosin placebo

DRUG

Finasteride placebo

Sponsors & Collaborators

• George Washington University

  collaborator OTHER

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

  lead NIH

Principal Investigators

• E. David Crawford · Clinic 01 - Univ of Colorado Health Sciences Center

• Steven A. Kaplan · Clinic 02 - New York Presbyterian Hospital

• Claus Roehrborn · Clinic 03 - UT Southwestern Medical Center

• Noah S. Schenkman · Clinic 04 - Walter Reed Army Medical Center

• Herbert Lepor · Clinic 06 - New York University School of Medicine

• Kevin M. Slawin · Clinic 07 - Baylor College of Medicine

• John P. Foley · Clinic 08 - Brooke Army Medical Center

• Joe W. Ramsdell · Clinic 09 - University of California San Diego

• Mani Menon · Clinic 10 - Henry Ford Hospital

• Michael M. Lieber · Clinic 11 - Mayo Foundation

• Kevin T. McVary · Clinic 12 - Northwestern University

• Joseph A. Smith · Clinic 13 - Vanderbilt University

• Gerald L. Andriole · Clinic 14 - Washington University

• Harris E. Foster · Clinic 15 - Yale University

• Harry S. Clarke · Clinic 16 - Emory University

• Karl J. Kreder · Clinic 17 - University of Iowa

• Stephen C. Jacobs · Clinic 18 - University of Maryland

• Gary J. Miller · Diagnostic Center - Univ of Colorado Health Sciences Center

• Oliver M. Bautista · Biostatistical Coordinating Center - George Washington Univ.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

1995-12-31

Primary Completion

2001-11-30

Completion

2001-11-30

FDA Drug

Yes

Countries

• United States

Study Locations