Medical Therapy of Prostatic Symptoms (MTOPS)

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Prostatic Hypertrophy, Benign; Prostatic Hyperplasia

Treatments: Drug: Doxazosin; Drug: Finasteride; Drug: Finasteride placebo; Drug: Doxazosin placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00021814

U01DK046472 (U.S. NIH Grant/Contract)

MTOPS (completed)

Details and patient eligibility

About

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.

Enrollment: 3,407 patients

Sex: Male

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,407 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Doxazosin and Finasteride placebos

Treatment:

Drug: Finasteride placebo

Drug: Doxazosin placebo

Doxazosin

Experimental group

Description:

Doxazosin and Finasteride placebo

Treatment:

Drug: Doxazosin

Drug: Finasteride placebo

Finasteride

Experimental group

Description:

Doxazosin placebo and Finasteride

Treatment:

Drug: Finasteride

Drug: Doxazosin placebo

Combination

Experimental group

Description:

Doxazosin and Finasteride

Treatment:

Drug: Doxazosin

Drug: Doxazosin placebo