Quality of Life Analysis of Treatment in Patients With Prostate Cancer on Adjuvant Zoladex Therapy - Full Text View

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

This study is currently recruiting participants.

Verified by AstraZeneca, June 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00692874

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

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Goserelin

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1973
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2010

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

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

Contacts

Contact: AstraZeneca Hungary Clinical Study Information

+36 23 517 300

csaba.csongvai@AstraZeneca.com

Locations

Hungary
Research Site	Recruiting
Baja, Hungary
Research Site	Active, not recruiting
Bekes, Hungary
Research Site	Active, not recruiting
Bekescsaba, Hungary
Research Site	Recruiting
Budapest, Hungary
Research Site	Active, not recruiting
Cegled, Hungary
Research Site	Recruiting
Dunaujvaros, Hungary
Research Site	Active, not recruiting
Erd, Hungary
Research Site	Active, not recruiting
Gyor, Hungary
Research Site	Active, not recruiting
Gyula, Hungary
Research Site	Active, not recruiting
Kiskunhalas, Hungary
Research Site	Active, not recruiting
Zalaegerszeg, Hungary
Research Site	Recruiting
Nyiregyhaza, Hungary
Research Site	Recruiting
Pecs, Hungary
Research Site	Recruiting
Sopron, Hungary
Research Site	Recruiting
Szeged, Hungary
Research Site	Active, not recruiting
Szekesfehervar, Hungary
Research Site	Recruiting
Szentendre, Hungary
Research Site	Active, not recruiting
Tatabanya, Hungary
Research Site	Recruiting
Vac, Hungary
Research Site	Active, not recruiting
Nagykoros, 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:	Gábor Berta	AstraZeneca Hungary

More Information

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

Keywords provided by AstraZeneca:

Quality of Life

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Goserelin
Quality of Life

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009