Effects of Alpha Blockers on Prostate-specific Antigen (PSA) Change in Men With Lower Urinary Tract Symptoms (LUTS)

Study Overview
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Brief Summary
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The correlation between the change of serum prostate-specific antigen (PSA) or PSA velocity (PSAV) and severity of lower urinary tract symptoms (LUTS) has been poorly understood. Previous studies usually focused on the treatment efficacy or preventive role of alpha blockers (AB) for clinical progression of benign prostatic hyperplasia (BPH) and AB therapy in real-life practice improved BPH/LUTS and reduced the risk of overall clinical progression. We hypothesized that the change of PSA and PSA velocity would be correlated to LUTS severity in the groups of BPH and prostate cancer.

Detailed Description
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Since successful treatment with alpha-1 adrenergic antagonists, or AB was reported first in 1975, the therapeutic efficacy has been widely accepted and now AB medication is considered the first-line choice worldwide among pharmacologic options for BPH-related LUTS. Previous studies usually focused on the treatment efficacy or preventive role of AB for clinical progression of BPH and AB therapy in real-life practice improved BPH/LUTS and reduced the risk of overall clinical progression. However, the correlation between the change of serum PSA or PSAV and severity of LUTS has been poorly understood. Some studies showed follow-up data of PSA during the study period, and they failed to show a significant change of PSA in the group of AB. In contrast, some other studies demonstrated that the possibility of PSA change with the presence of LUTS and it is early to tell conclusively that there would be no relationship between PSA values and LUTS severity. Because a PSA value is considered an important factor to determine whether transrectal prostate biopsy should be performed, We hypothesized that the change of PSA and PSAV would be correlated to LUTS severity in the groups of BPH and prostate cancer.

Conditions
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Benign Prostatic Hyperplasia, Prostate Cancer

Intervention / Treatment
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* Other: PSA measurement, uroflowmetry, IPSS, transrectal ultrasonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: more than two consecutive PSA measurements before the biopsy and the medication periods of AB more than 3 months in all patients Exclusion Criteria: any prostate surgery during the study period, any prostate disease with evidence of prostatic inflammation, any urologic surgery before PSA measurement, and medication history of anticholinergics or 5-alpha reductase inhibitors

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BPH<br>men aged more than 40 years who presented with BPH/LUTS and showed negative results of transrectal prostate biopsy before the period of AB medication | Other: PSA measurement, uroflowmetry, IPSS, transrectal ultrasonography<br> <br> |
| prostate cancer<br>men aged more than 40 years who presented with BPH/LUTS and showed positive results of transrectal prostate biopsy before the period of AB medication | Other: PSA measurement, uroflowmetry, IPSS, transrectal ultrasonography<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSAV | PSAV values were calculated by a simple method: [(last PSA values - initial PSA values)/measurement period (month)] | calculated PSAV using baseline PSA value and PSA 6 month or 1 year after initial PSA measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| international prostate symptoms symptom score (IPSS), maximal flow rate (Qmax) | IPSS scores, quality of life (QOL) scores of IPSS questionnaire (Question 8), and maximal flow rates (Qmax) | IPSS scores and Qmax values at the time of baseline PSA measurement and 6 month or 1 year after initial PSA measurement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate, prostate-specific antigen, benign prostatic hyperplasia, adrenergic alpha-Antagonists