Medical Therapy of Prostatic Symptoms

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.

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hypertrophy, Benign Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

University of California, La Jolla, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doxazosin

Drug

finasteride

Drug

Doxazosin placebo

Drug

Finasteride placebo

Drug

Sponsors and collaborators

Lead sponsor

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

Nih

Collaborators

George Washington University

Registry information

Acronym: MTOPS

Important dates

Study start: 1995
Primary completion: 2001
Study completion: 2001
First posted: Aug 6, 2001
Registry last updated: Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed