Prostate CancerNCT02088164
Long-Term Outcome of Subjects With Elevated PSA in Healthy Taiwanese Men
An observational study of Prostate Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To determine the long-term survival outcome of subjects who had various PSA levels at screening Read more about this study
- Who is it for?
- Ages 41 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 27,741 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2012to Apr 2012
- 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 41 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Taiwanese healthy men who are older than 40 years
Who may be able to join
- Health men who received PSA screening at NTUH and CGMH
Who cannot join
- Prior history of prostate cancer
Trial locations and contacts
1 site in 1 country.
About this study
To determine the long-term survival outcome of subjects who had various PSA levels at screening
- Conditions
- Prostate Cancer
- Keywords
- PSA,, asian men,, survival
- 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 |
|---|---|---|
| Healthy men | Healthy men who received PSA screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of prostate cancer
Measured: 20 years (average)
Secondary outcomes (2)
Cancer-specific death
Measured: 20 years (average)
Overall survival
Measured: 20 years (average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 27,741 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yeong-Shiau Pu, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088164
- Sponsor's protocol ID
- 200809020
- Status last verified
- Mar 2014
- First submitted
- 16 May 2012
- Last updated
- 14 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Outcome of Subjects With Elevated PSA in Healthy Taiwanese Men
- ClinicalTrials.gov ID
- NCT02088164
- Acronym / sponsor ID
- 200809020
- Conditions
- Prostate Cancer
- Keywords
- PSA,, asian men,, survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27,741 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- First posted
- 14 Mar 2014 (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.
To determine the long-term survival outcome of subjects who had various PSA levels at screening
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy men | – | –Healthy men who received PSA screening |
Who may qualify
- Ages
- 41 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Taiwanese healthy men who are older than 40 years
Key inclusion criteria (1 listed)
- Health men who received PSA screening at NTUH and CGMH
Key exclusion criteria (1 listed)
- Prior history of 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
Diagnosis of prostate cancer
Time frame: 20 years (average)
2 secondary outcomes
Cancer-specific death
Time frame: 20 years (average)
Overall survival
Time frame: 20 years (average)
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 14 Mar 2014.
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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.
Yeong-Shiau Pu, PhD principal investigator
National Taiwan 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 Prostate Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 14 Mar 2014. 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 Taiwan. 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?
Diagnosis of prostate cancer (time frame: 20 years (average)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2014.