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

Samsung Medical Center25 enrolled

Overview

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)

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Benign Prostatic Hyperplasia

Interventions

DoxazosinDRUG

Treatment with doxazosin 4mg daily for 24 mos

DoxazosinDRUG

Treatment with doxazosin 8mg daily for 24 mos

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Expression of alpha-1 adrenoceptor

Time frame: before treatment and 12mos and 24 mos after treatment

Secondary Outcomes

International Prostate Symptom Score, Patient perception of bladder condition, Maximal flow rate of urine, Postvoid Residual, Prostate volume, Serum PSA level, Adverse events

Time frame: before treatment and 3mos, 12mos, and 24mos after treatment

Data from ClinicalTrials.gov

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