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Aggressive Prostate Cancers in Elderly Patients

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ClinicalTrials.gov Identifier: NCT01347476
Recruitment Status : Completed
First Posted : May 4, 2011
Last Update Posted : May 19, 2011
Information provided by:

Study Description
Brief Summary:
Patients aged 70 years or older had a higher possibility of high risk cancer than younger patients.

Condition or disease
Prostatic Neoplasms

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.

Study Design

Study Type : Observational
Actual Enrollment : 1333 participants
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
Study Start Date : January 2010
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Groups and Cohorts

patients older than 70 years
patients 70 years or younger

Outcome Measures

Primary Outcome Measures :
  1. biochemical recurrences (BCR) [ Time Frame: 5 year-BCR ]
    BCR was defined as two consecutive increasing PSA values of more than 0.2 ng/mL

Secondary Outcome Measures :
  1. pathologic outcomes [ Time Frame: postoperative 1 week ]
    biopsy or pathologic Gleason scores, mean percent of positive cores and tumor volume percent, Extracapsular extension and seminal vesicle invasion

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347476

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

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
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: May 2011

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

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