Medical Therapy of Prostatic Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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Medical Therapy of Prostatic Symptoms

Conditions
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Prostatic Hyperplasia, Prostatic Hypertrophy, Benign

Intervention / Treatment
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* Drug: Doxazosin
* Drug: Finasteride
* Drug: Doxazosin placebo
* Drug: Finasteride placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Doxazosin and Finasteride placebos | Drug: Doxazosin placebo<br> <br> Drug: Finasteride placebo<br> <br> |
| Experimental: Doxazosin<br>Doxazosin and Finasteride placebo | Drug: Doxazosin<br> <br> Drug: Finasteride placebo<br> <br> |
| Experimental: Finasteride<br>Doxazosin placebo and Finasteride | Drug: Finasteride<br> <br> Drug: Doxazosin placebo<br> <br> |
| Experimental: Combination<br>Doxazosin and Finasteride | Drug: Doxazosin<br> <br> Drug: Doxazosin placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH progression, Medical Therapy, Finasteride, Doxazosin, Randomized, Multi-center, Clinical Trial, Proscar, Cardura