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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01250483
First received: November 25, 2010
Last updated: November 27, 2010
Last verified: November 2010

November 25, 2010
November 27, 2010
January 2001
December 2009   (final data collection date for primary outcome measure)
PSAV [ Time Frame: calculated PSAV using baseline PSA value and PSA 6 month or 1 year after initial PSA measurement ] [ Designated as safety issue: No ]
PSAV values were calculated by a simple method: [(last PSA values - initial PSA values)/measurement period (month)]
Same as current
Complete list of historical versions of study NCT01250483 on ClinicalTrials.gov Archive Site
international prostate symptoms symptom score (IPSS), maximal flow rate (Qmax) [ Time Frame: IPSS scores and Qmax values at the time of baseline PSA measurement and 6 month or 1 year after initial PSA measurement ] [ Designated as safety issue: No ]
IPSS scores, quality of life (QOL) scores of IPSS questionnaire (Question 8), and maximal flow rates (Qmax)
Same as current
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Effects of Alpha Blockers on Prostate-specific Antigen (PSA) Change in Men With Lower Urinary Tract Symptoms (LUTS)
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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.

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Probability Sample

Men aged more than 40 years who presented with BPH/LUTS and performed transrectal prostate biopsy during the period of AB medication between January 2001 and December 2009.

  • Benign Prostatic Hyperplasia
  • Prostate Cancer
Other: PSA measurement, uroflowmetry, IPSS, transrectal ultrasonography
  • 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
    Intervention: 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
    Intervention: Other: PSA measurement, uroflowmetry, IPSS, transrectal ultrasonography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Male
40 Years to 80 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01250483
PSA and alpha blockers
Yes
Not Provided
Seoul National University Hospital
Not Provided
Principal Investigator: Cheol Kwak, M.D.,Ph.D. Seoul National University Hospital
Seoul National University Hospital
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP