Korean Practice Patterns for Screening PCA(Prostate Cancer) (RESPECT)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01371513
First received: May 12, 2011
Last updated: November 3, 2011
Last verified: October 2011
  Purpose

This is to investigate Korean urologist's practice patterns for screening prostate cancer according to PSA level.


Condition Intervention
Neoplasms, Prostate
Prostate Cancer
Benign Prostatic Hyperplasia
Other: continuous screening

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Korean's Practice Patterns for Screening PCA(Prostate Cancer) According to PSA(Prostate-specific Antigen) Level

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of subjects with prostate biopsy [ Time Frame: 1year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects with prostate cancer [ Time Frame: 1year ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: May 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PSA level
more than 2.5ng/ml
Other: continuous screening
practice patterns for screening prostate cancer

Detailed Description:

This is to investigate Korean urologist's practice patterns for screening prostate cancer according to PSA level.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects with PSA more than 2.5ng/ml in 2008 from urology department of clinic and general hospital

Criteria

Inclusion Criteria:

  • Male with PSA more than 2.5ng/ml from 1 Jan 2008 to 31 Dec 2008

Exclusion Criteria:

  • Age less than 40 at PSA screening
  • History of drug use which can affect level of PSA within 6months before PSA screening
  • Subject who participate any other clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01371513

Locations
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 135-720
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01371513     History of Changes
Other Study ID Numbers: 113951
Study First Received: May 12, 2011
Last Updated: November 3, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Serum prostate specific antigen

Additional relevant MeSH terms:
Prostatic Hyperplasia
Neoplasms
Hyperplasia
Prostatic Neoplasms
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on April 16, 2014