Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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In this study, we investigate the changes of the expression of alpha adrenergic receptor in the prostate tissue during 2-yr medication period in the man with benign prostatic hyperplasia. And we also evaluate the efficacy and safety of 24 mo-treatment with doxazosin (4mg, 8mg)

Detailed Description
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To compare the expression of alpha-1 adrenergic receptors, we will use various methodologies such as Real-time RT-PCR Radioligand receptor binding Western blot Immunohistochemistry

Official Title
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A Prospective Study for the Effects of Chronic Use of Doxazosin on Alpha 1-adrenergic Receptors in Men With Benign Prostatic Hyperplasia

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Doxazosin
* Drug: Doxazosin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 yrs or greater International prostatic symptom score >= 8 Maximal flow rate < 15mL/sec baseline PSA 2.5-10 ng/mL Pathologically proven BPH No medication history for BPH Able to give fully informed consent Exclusion Criteria: Previous use of alpha-blocker, 5-alpha reductase inhibitor Previous surgery for BPH Urologic cancer history Urethral stricture baseline PSA > 10ng/mL BP < 90/70 mmHg Orthotopic hypotension with syncope Serum Cr > 2.0 mg/dl, alanine aminotransferase > 1.5 times of normal limit Bacterial prostatitis within 1 year Urinary tract infection(UTI) more than 2 times within 1 year Active UTI or prostate biopsy within 1 month Unable to void Ped use because of incontinence Hypersensitivity to alpha-blocker that include quinazoline Unstable angina, Myocardial infarction, or cerebrovascular accident within 6 months Neurogenic bladder dysfunction (ex. multiple sclerosis, Parkinson's disease, Spinal injury etc.) Psychiatric problem Alcohol abuse or other drug abuse history Severe comorbidities unable to perform long-term trial seems not to be appropriate to this study because of any other reasons

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: doxazosin 4mg<br>doxazosin 4mg group | Drug: Doxazosin<br>* Treatment with doxazosin 4mg daily for 24 mos<br>* Other names: Cadura XL 4mg;|
| Experimental: doxazosin 8mg<br>doxazosin 8mg group | Drug: Doxazosin<br>* Treatment with doxazosin 8mg daily for 24 mos<br>* Other names: Cadura XL 8mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of alpha-1 adrenoceptor |  | before treatment and 12mos and 24 mos after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score, Patient perception of bladder condition, Maximal flow rate of urine, Postvoid Residual, Prostate volume, Serum PSA level, Adverse events |  | before treatment and 3mos, 12mos, and 24mos after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Prostatic Hyperplasia, alpha Adrenergic Blockers, alpha-1 Adrenergic Receptor