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Aggressive Prostate Cancers in Elderly Patients

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01347476
First received: April 29, 2011
Last updated: May 18, 2011
Last verified: May 2011
History of Changes
  Purpose

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


Condition
Prostatic Neoplasms

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Patients Aged More Than 70 Had More Aggressive Prostate Cancers and Higher Risk of Biochemical Recurrence in Korea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • biochemical recurrences (BCR) [ Time Frame: 5 year-BCR ] [ Designated as safety issue: No ]
    BCR was defined as two consecutive increasing PSA values of more than 0.2 ng/mL


Secondary Outcome Measures:
  • pathologic outcomes [ Time Frame: postoperative 1 week ] [ Designated as safety issue: No ]
    biopsy or pathologic Gleason scores, mean percent of positive cores and tumor volume percent, Extracapsular extension and seminal vesicle invasion


Enrollment: 1333
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients older than 70 years
patients 70 years or younger

Detailed Description:

Patients aged 70 years or older had a higher risk of advanced prostate cancer and shorter BCR-free survival than younger ones. Definite treatment of clinically localized prostate cancer should be actively considered in well-selected healthy patients older than 70 years.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • insufficient clinical data
  • poor health status
  • clinically advanced prostate cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347476

Locations
Korea, Republic of
Seoul National University Boramae Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Sung Yong Cho, M.D. Seoul National University Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Seoul National University Boramae Hospital
ClinicalTrials.gov Identifier: NCT01347476     History of Changes
Other Study ID Numbers: old age prostate, elderly pts with high risk CaP
Study First Received: April 29, 2011
Last Updated: May 18, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
prostate-specific antigen
radical prostatectomy

Additional relevant MeSH terms:
Aggression
Neoplasms
Prostatic Neoplasms
Behavioral Symptoms
Genital Neoplasms, Male
 Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013