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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
  Purpose

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 Intervention
Benign Prostatic Hyperplasia
Prostate Cancer
Other: PSA measurement, uroflowmetry, IPSS, transrectal ultrasonography

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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)]


Secondary Outcome Measures:
  • 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)


Enrollment: 174
Study Start Date: January 2001
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250483

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Cheol Kwak, M.D.,Ph.D. Seoul National University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01250483     History of Changes
Other Study ID Numbers: PSA and alpha blockers
Study First Received: November 25, 2010
Last Updated: November 27, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
prostate
prostate-specific antigen
benign prostatic hyperplasia
adrenergic alpha-Antagonists

Additional relevant MeSH terms:
Hyperplasia
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Pathologic Processes
Prostatic Diseases
Signs and Symptoms
Urogenital Neoplasms
Urological Manifestations

ClinicalTrials.gov processed this record on November 23, 2014