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

NCT01250483 — Completed, 174 participants, Seoul National University Hospital

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RegistryNCT01250483
StatusCompleted
Study typeObservational
Enrollment174 (Actual)
SponsorSeoul National University Hospital (Other)
ConditionsBenign Prostatic Hyperplasia, Prostate Cancer
InterventionsPSA measurement, uroflowmetry, IPSS, transrectal ultrasonography (Other)
Datesstart 2001-01-01, primary completion 2009-12-01, completion 2009-12-01, first posted 2010-11-30, last updated 2010-11-30
Locations1 site in South Korea

Related Papers Related Patents Related Grants Related Experts
All trials for Benign Prostatic Hyperplasia All trials for Prostate Cancer All trials of PSA measurement, uroflowmetry, IPSS, transrectal ultrasonography

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
BPHOther: PSA measurement, uroflowmetry, IPSS, transrectal ultrasonographymen aged more than 40 years who presented with BPH/LUTS and showed negative results of transrectal prostate biopsy before the period of AB medication
prostate cancerOther: PSA measurement, uroflowmetry, IPSS, transrectal ultrasonographymen aged more than 40 years who presented with BPH/LUTS and showed positive results of transrectal prostate biopsy before the period of AB medication
  • PSA measurement, uroflowmetry, IPSS, transrectal ultrasonography (Other)

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

Sex: Male, ages: 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

+Locations (1)

FacilityCityCountryStatus
Seoul National University HospitalSeoul, SeoulSouth Korea

+Investigators