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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00692874
First received: June 5, 2008
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

This is an open label, non-interventional quality of life analysis for Zoladex treated prostate cancer patients by investigator's questionnaire


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life Analysis of Prostate Cancer Patient's Therapy

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Elements of a general and three disease-specific investigator questionnaire [ Time Frame: Quarterly (plus or minus 3 days ) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator Assessment Report [ Time Frame: Yearly (plus or minus 1 week ) ] [ Designated as safety issue: No ]

Enrollment: 1646
Study Start Date: June 2008
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692874

Locations
Hungary
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Péter Tenke, M.D. "Jahn Ferenc" City Hospital Budapest
Study Director: Csaba Csongvai AstraZeneca Hungary
Study Chair: Éva Gulyás AstraZeneca Hungary
  More Information

No publications provided

Responsible Party: Francisco Sapunar Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00692874     History of Changes
Other Study ID Numbers: NIS-OHU-ZOL-2007/1
Study First Received: June 5, 2008
Last Updated: December 9, 2010
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by AstraZeneca:
Quality of Life

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014