Prostate CancerNCT01220427
Micro-RNA Expression Profiles in High Risk Prostate Cancer
An observational study of Prostate Cancer and Radical Prostatectomy, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether specific Micro-RNA expression profiles are related to Prostate cancer outcome. Read more about this study
- Who is it for?
- Ages 35 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Radical Prostatectomy
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2007to not given
- 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 35 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: University hospital, community hospital
Who may be able to join
- Patients with clinically localised high risk prostate cancer (cT>2, bx GS >7, PSA >20 ng/ml) scheduled for radical prostatectomy.
Who cannot join
- Non high risk prostate cancer
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Urology and Pediatric Urology University Hospital Würzburg
Würzburg, 97080
About this study
The purpose of this study is to determine whether specific Micro-RNA expression profiles are related to Prostate cancer outcome.
- Conditions
- Prostate Cancer, Radical Prostatectomy
- Keywords
- high-risk prostate cancer, radical prostatectomy, micro-RNA
- 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 |
|---|---|---|
| Clinical high-risk prostate cancer, radical prostatectomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival
The patients will be followed in regular time intervals in accordance with the EAU-Guidelines (2010) and the S-3 Guideline for Prostate cancer of the German Urological Association. Data will be updated once yearly for until death.
Measured: Yearly update until clinical progression
Secondary outcomes (1)
Cancer specific survival
The patients will be followed in regular time intervals in accordance with the EAU-Guidelines (2010) and the S-3 Guideline for Prostate cancer of the German Urological Association. Data will be updated once yearly until death.
Measured: Yearly update until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startJun 2007
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.
- 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
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220427
- Sponsor's protocol ID
- mi-RNA HR-Pca
- Status last verified
- Aug 2010
- First submitted
- 12 Oct 2010
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-RNA Expression Profiles in High Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT01220427
- Acronym / sponsor ID
- mi-RNA HR-Pca
- Conditions
- Prostate Cancer, Radical Prostatectomy
- Keywords
- high-risk prostate cancer, radical prostatectomy, micro-RNA
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- Jun 2007
- First posted
- 13 Oct 2010 (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.
The purpose of this study is to determine whether specific Micro-RNA expression profiles are related to Prostate cancer outcome.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical high-risk prostate cancer, radical prostatectomy | – | – |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University hospital, community hospital
Key inclusion criteria (1 listed)
- Patients with clinically localised high risk prostate cancer (cT>2, bx GS >7, PSA >20 ng/ml) scheduled for radical prostatectomy.
Key exclusion criteria (1 listed)
- Non high risk 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
Recurrence free survival
Time frame: Yearly update until clinical progression
The patients will be followed in regular time intervals in accordance with the EAU-Guidelines (2010) and the S-3 Guideline for Prostate cancer of the German Urological Association. Data will be updated once yearly for until death.
1 secondary outcome
Cancer specific survival
Time frame: Yearly update until death
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Radical Prostatectomy, run by Wuerzburg University Hospital at 1 site in Germany.
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: stopped early, as of the sponsor's last update on 3 Mar 2016. 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 Germany. 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 was stopped early. Results are not available in the source record.
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?
Recurrence free survival (time frame: Yearly update until clinical progression). 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 3 Mar 2016.