NCT01371513

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 12, 2011

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
Last Updated

May 22, 2017

Status Verified

May 1, 2017

Enrollment Period

1.1 years

First QC Date

May 12, 2011

Last Update Submit

May 19, 2017

Conditions

Neoplasms, ProstateProstate CancerBenign Prostatic Hyperplasia

Keywords

Serum prostate specific antigen

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with prostate biopsy

    1year

Secondary Outcomes (1)

  • Number of subjects with prostate cancer

    1year

Study Arms (1)

PSA level

more than 2.5ng/ml

Other: continuous screening

Interventions

continuous screeningOTHER

practice patterns for screening prostate cancer

PSA level

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Seoul, 135-720, South Korea

Location

MeSH Terms

Conditions

Prostatic NeoplasmsProstatic Hyperplasia

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2011

First Posted

June 10, 2011

Study Start

May 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 22, 2017

Record last verified: 2017-05

Locations

KR(1)