NCT01347476

Brief Summary

Patients aged 70 years or older had a higher possibility of high risk cancer than younger patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,333

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

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

January 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2011

Completed
Last Updated

May 19, 2011

Status Verified

May 1, 2011

Enrollment Period

9 months

First QC Date

April 29, 2011

Last Update Submit

May 18, 2011

Conditions

Keywords

prostate-specific antigenradical prostatectomy

Outcome Measures

Primary Outcomes (1)

  • biochemical recurrences (BCR)

    BCR was defined as two consecutive increasing PSA values of more than 0.2 ng/mL

    5 year-BCR

Secondary Outcomes (1)

  • pathologic outcomes

    postoperative 1 week

Study Arms (2)

patients older than 70 years

patients 70 years or younger

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men who underwent radical prostatectomy for the treatment of clinically localized prostate cancer

You may qualify if:

  • clinically localized prostate cancer
  • good health status
  • follow-up period more than 12 months

You may not qualify if:

  • insufficient clinical data
  • poor health status
  • clinically advanced prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Boramae Hospital

Seoul, Seoul, South Korea

Location

Related Publications (1)

  • Kim JK, Cho SY, Jeong CW, Lee SB, Ku JH, Hong SK, Byun SS, Kwak C, Him HH, Lee SE, Jeong H. Patients aged more than 70 had higher risk of locally advanced prostate cancers and biochemical recurrence in Korea. BJU Int. 2012 Aug;110(4):505-9. doi: 10.1111/j.1464-410X.2011.10927.x. Epub 2012 Feb 7.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sung Yong Cho, M.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

April 29, 2011

First Posted

May 4, 2011

Study Start

January 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

May 19, 2011

Record last verified: 2011-05

Locations