Prostatic NeoplasmsNCT01347476
Aggressive Prostate Cancers in Elderly Patients
An observational study of Prostatic Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Patients aged 70 years or older had a higher possibility of high risk cancer than younger patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostatic Neoplasms
- How many people
- 1,333 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men who underwent radical prostatectomy for the treatment of clinically localized prostate cancer
Who may be able to join
- clinically localized prostate cancer
- good health status
- follow-up period more than 12 months
Who cannot join
- insufficient clinical data
- poor health status
- clinically advanced prostate cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostatic Neoplasms
- Keywords
- prostate-specific antigen, radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients older than 70 years | Not described | |
| patients 70 years or younger | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
biochemical recurrences (BCR)
BCR was defined as two consecutive increasing PSA values of more than 0.2 ng/mL
Measured: 5 year-BCR
Secondary outcomes (1)
pathologic outcomes
biopsy or pathologic Gleason scores, mean percent of positive cores and tumor volume percent, Extracapsular extension and seminal vesicle invasion
Measured: postoperative 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startJan 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sung Yong Cho, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347476
- Sponsor's protocol ID
- old age prostate
- Other IDs
- elderly pts with high risk CaP
- Status last verified
- May 2011
- First submitted
- 29 Apr 2011
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22314007
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Aged More Than 70 Had More Aggressive Prostate Cancers and Higher Risk of Biochemical Recurrence in Korea
- ClinicalTrials.gov ID
- NCT01347476
- Acronym / sponsor ID
- old age prostate
- Conditions
- Prostatic Neoplasms
- Keywords
- prostate-specific antigen, radical prostatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,333 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 4 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients aged 70 years or older had a higher possibility of high risk cancer than younger patients.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients older than 70 years | – | – |
| patients 70 years or younger | – | – |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men who underwent radical prostatectomy for the treatment of clinically localized prostate cancer
Key inclusion criteria (3 listed)
- clinically localized prostate cancer
- good health status
- follow-up period more than 12 months
Key exclusion criteria (3 listed)
- insufficient clinical data
- poor health status
- clinically advanced prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
biochemical recurrences (BCR)
Time frame: 5 year-BCR
BCR was defined as two consecutive increasing PSA values of more than 0.2 ng/mL
1 secondary outcome
pathologic outcomes
Time frame: postoperative 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- Derived from this study: PubMed 22314007Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Yong Cho, M.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemical recurrences (BCR) (time frame: 5 year-BCR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01347476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.