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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01250483

Collaborator

(none)

174

Enrollment

Location

107

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia Prostate Cancer	Other: PSA measurement, uroflowmetry, IPSS, transrectal ultrasonography

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

174 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Study Start Date :

Jan 1, 2001

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
BPH 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
prostate cancer 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

Arm

Intervention/Treatment

BPH

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

prostate cancer

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

Male

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