Prostate CancerAZTEK EXTNCT00692874
Quality of Life Analysis of Treatment in Patients With Prostate Cancer on Adjuvant Zoladex Therapy
An observational study of Prostate Cancer, run by AstraZeneca at 20 sites in Hungary.
Trial summary
This is an open label, non-interventional quality of life analysis for Zoladex treated prostate cancer patients by investigator's questionnaire Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 1,646 participants
- Where
- 20 sitesHungary
- Study dates
- Jun 2008to Sep 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Early or locally-advanced prostate cancer patients on androgen deprivation therapy
Who may be able to join
- Provision of informed consent
- Early or locally-advanced prostate cancer patients on androgen deprivation therapy
- Investigators are requested to recruit patients only with at least 1 month prior Zoladex treatment.
Who cannot join
- Allergy to substance of medication
- Prostate cancer patients with advanced disease
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Hungary20 sites
Research Site
Baja
Research Site
Békés
Research Site
Békéscsaba
Research Site
Budapest
Research Site
Cegléd
Research Site
Dunaújváros
Research Site
Érd
Research Site
Győr
Research Site
Gyula
Research Site
Kiskunhalas
Research Site
Nagykőrös
Research Site
Nyíregyháza
Research Site
Pécs
Research Site
Sopron
Research Site
Szeged
Research Site
Székesfehérvár
Research Site
Szentendre
Research Site
Tatabánya
Research Site
Vác
Research Site
Zalaegerszeg
About this study
Official title: Quality of Life Analysis of Prostate Cancer Patient's Therapy
This is an open label, non-interventional quality of life analysis for Zoladex treated prostate cancer patients by investigator's questionnaire
- Conditions
- Prostate Cancer
- Keywords
- Quality of Life
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Elements of a general and three disease-specific investigator questionnaire
Measured: Quarterly (plus or minus 3 days )
Secondary outcomes (1)
Investigator Assessment Report
Measured: Yearly (plus or minus 1 week )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2010
- Study completionSep 2010
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 AstraZenecaThe 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
- Prospective
- Enrolment
- 1,646 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Péter Tenke, M.D., Principal investigator, "Jahn Ferenc" City Hospital BudapestCsaba Csongvai, Study director, AstraZeneca HungaryÉva Gulyás, Study chair, AstraZeneca Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692874
- Sponsor's protocol ID
- NIS-OHU-ZOL-2007/1
- Acronym
- AZTEK EXT
- Status last verified
- Dec 2010
- First submitted
- 5 Jun 2008
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Analysis of Prostate Cancer Patient's Therapy
- ClinicalTrials.gov ID
- NCT00692874
- Acronym / sponsor ID
- AZTEK EXT / NIS-OHU-ZOL-2007/1
- Conditions
- Prostate Cancer
- Keywords
- Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,646 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 6 Jun 2008 (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.
This is an open label, non-interventional quality of life analysis for Zoladex treated prostate cancer patients by investigator's questionnaire
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Early or locally-advanced prostate cancer patients on androgen deprivation therapy
Key inclusion criteria (3 listed)
- Provision of informed consent
- Early or locally-advanced prostate cancer patients on androgen deprivation therapy
- Investigators are requested to recruit patients only with at least 1 month prior Zoladex treatment.
Key exclusion criteria (2 listed)
- Allergy to substance of medication
- Prostate cancer patients with advanced disease
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
Elements of a general and three disease-specific investigator questionnaire
Time frame: Quarterly (plus or minus 3 days )
1 secondary outcome
Investigator Assessment Report
Time frame: Yearly (plus or minus 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 10 Dec 2010.
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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.
Péter Tenke, M.D. principal investigator
"Jahn Ferenc" City Hospital Budapest
Csaba Csongvai study director
AstraZeneca Hungary
Éva Gulyás study chair
AstraZeneca Hungary
20 sites 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 AstraZeneca at 20 sites in Hungary.
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 2 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 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Hungary. 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?
Elements of a general and three disease-specific investigator questionnaire (time frame: Quarterly (plus or minus 3 days )). 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 10 Dec 2010.