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

NCT01250483 | Completed DMC

• 1 other identifier: PSA and alpha blockers
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia; Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• PSAV

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

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

Secondary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

PSA measurement, uroflowmetry, IPSS, transrectal ultrasonography OTHER

BPH; prostate cancer

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• more than two consecutive PSA measurements before the biopsy and the medication periods of AB more than 3 months in all patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Prostatic Neoplasms

Interventions

Prostate-Specific Antigen

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Kallikreins; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Prostatic Secretory Proteins; Seminal Plasma Proteins; Seminal Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens, Neoplasm; Antigens; Biological Factors; Biomarkers, Tumor; Biomarkers

Study Officials

• Cheol Kwak, M.D.,Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 25, 2010
• First Posted: November 30, 2010
• Study Start: January 1, 2001
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 30, 2010

Record last verified: 2010-11

Locations

KR (1)