Quality of Life Analysis of Treatment in Patients With Prostate Cancer on Adjuvant Zoladex Therapy (AZTEK EXT)

December 9, 2010 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1646

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

  • Hungary
      • Baja, Hungary
        • Research Site
      • Bekes, Hungary
        • Research Site
      • Bekescsaba, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Cegled, Hungary
        • Research Site
      • Dunaujvaros, Hungary
        • Research Site
      • Erd, Hungary
        • Research Site
      • Gyor, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Kiskunhalas, Hungary
        • Research Site
      • Nagykoros, Hungary
        • Research Site
      • Nyiregyhaza, Hungary
        • Research Site
      • Pecs, Hungary
        • Research Site
      • Sopron, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
      • Szekesfehervar, Hungary
        • Research Site
      • Szentendre, Hungary
        • Research Site
      • Tatabanya, Hungary
        • Research Site
      • Vac, Hungary
        • Research Site
      • Zalaegerszeg, Hungary
        • Research Site

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Early or locally-advanced prostate cancer patients on androgen deprivation therapy

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Allergy to substance of medication
  • Prostate cancer patients with advanced disease

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Elements of a general and three disease-specific investigator questionnaire
Time Frame: Quarterly (plus or minus 3 days )
Quarterly (plus or minus 3 days )

Secondary Outcome Measures

Outcome Measure
Time Frame
Investigator Assessment Report
Time Frame: Yearly (plus or minus 1 week )
Yearly (plus or minus 1 week )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Péter Tenke, M.D., "Jahn Ferenc" City Hospital Budapest

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

June 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

June 5, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

December 10, 2010

Last Update Submitted That Met QC Criteria

December 9, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OHU-ZOL-2007/1

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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