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40 Years
80 Years
Not Enrolling
Benign Prostatic Hyperplasia, Prostate Cancer

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Trial Information

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.

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

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:


Outcome Description:

PSAV values were calculated by a simple method: [(last PSA values - initial PSA values)/measurement period (month)]

Outcome Time Frame:

calculated PSAV using baseline PSA value and PSA 6 month or 1 year after initial PSA measurement

Safety Issue:


Principal Investigator

Cheol Kwak, M.D.,Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital


Korea: Institutional Review Board

Study ID:

PSA and alpha blockers



Start Date:

January 2001

Completion Date:

December 2009

Related Keywords:

  • Benign Prostatic Hyperplasia
  • Prostate Cancer
  • prostate
  • prostate-specific antigen
  • benign prostatic hyperplasia
  • adrenergic alpha-Antagonists
  • Prostatic Hyperplasia
  • Hyperplasia
  • Prostatic Neoplasms