Medical Therapy of Prostatic Symptoms

Completed · Phase 3 · Has a placebo group

Conditions studied: Prostatic Hyperplasia, Prostatic Hypertrophy, Benign

In brief

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.

Key facts

Study ID

NCT00021814

Run by

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

People needed

3407

Starts

1995-12-01

Expected to finish

2001-11-30

Last updated by the study team

2018-09-28

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California — La Jolla, California, United States
• Univ of Colorado Health Sciences Center — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Iowa Hospitals Clinics — Iowa City, Iowa, United States
• University of Maryland — Baltimore, Maryland, United States
• Henry Ford Health Systems — Detroit, Michigan, United States
• Mayo Foundation — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• New York University School of Medicine — New York, New York, United States
• Columbia Presbyterian Medical Center — New York, New York, United States
• Vanderbilt University — Nashville, Tennessee, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Brooke Army Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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