- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01347476
Aggressive Prostate Cancers in Elderly Patients
May 18, 2011 updated by: Seoul National University Hospital
Patients Aged More Than 70 Had More Aggressive Prostate Cancers and Higher Risk of Biochemical Recurrence in Korea
Patients aged 70 years or older had a higher possibility of high risk cancer than younger patients.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
1333
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
- Seoul National University Boramae Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Men who underwent radical prostatectomy for the treatment of clinically localized prostate cancer
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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patients older than 70 years
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patients 70 years or younger
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
biochemical recurrences (BCR)
Time Frame: 5 year-BCR
|
BCR was defined as two consecutive increasing PSA values of more than 0.2 ng/mL
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5 year-BCR
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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postoperative 1 week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sung Yong Cho, M.D., Seoul National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
April 29, 2011
First Submitted That Met QC Criteria
May 3, 2011
First Posted (Estimate)
May 4, 2011
Study Record Updates
Last Update Posted (Estimate)
May 19, 2011
Last Update Submitted That Met QC Criteria
May 18, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- old age prostate
- elderly pts with high risk CaP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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