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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01250483
Enrollment
174
Registered
2010-11-30
Start date
2001-01-31
Completion date
2009-12-31
Last updated
2010-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia, Prostate Cancer

Keywords

prostate, prostate-specific antigen, benign prostatic hyperplasia, adrenergic alpha-Antagonists

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.

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.

Interventions

OTHERPSA measurement, uroflowmetry, IPSS, transrectal ultrasonography

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
40 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
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 measurementIPSS scores, quality of life (QOL) scores of IPSS questionnaire (Question 8), and maximal flow rates (Qmax)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026