NCT00692874

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,646

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Typical duration for all trials

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

December 10, 2010

Status Verified

December 1, 2010

Enrollment Period

2.1 years

First QC Date

June 5, 2008

Last Update Submit

December 9, 2010

Conditions

Keywords

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • Elements of a general and three disease-specific investigator questionnaire

    Quarterly (plus or minus 3 days )

Secondary Outcomes (1)

  • Investigator Assessment Report

    Yearly (plus or minus 1 week )

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Research Site

Baja, Hungary

Location

Research Site

Békés, Hungary

Location

Research Site

Békéscsaba, Hungary

Location

Research Site

Budapest, Hungary

Location

Research Site

Cegléd, Hungary

Location

Research Site

Dunaújváros, Hungary

Location

Research Site

Érd, Hungary

Location

Research Site

Győr, Hungary

Location

Research Site

Gyula, Hungary

Location

Research Site

Kiskunhalas, Hungary

Location

Research Site

Nagykőrös, Hungary

Location

Research Site

Nyíregyháza, Hungary

Location

Research Site

Pécs, Hungary

Location

Research Site

Sopron, Hungary

Location

Research Site

Szeged, Hungary

Location

Research Site

Szentendre, Hungary

Location

Research Site

Székesfehérvár, Hungary

Location

Research Site

Tatabánya, Hungary

Location

Research Site

Vác, Hungary

Location

Research Site

Zalaegerszeg, Hungary

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Péter Tenke, M.D.

    "Jahn Ferenc" City Hospital Budapest

    PRINCIPAL INVESTIGATOR
  • Csaba Csongvai

    AstraZeneca Hungary

    STUDY DIRECTOR
  • Éva Gulyás

    AstraZeneca Hungary

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 6, 2008

Study Start

June 1, 2008

Primary Completion

July 1, 2010

Study Completion

September 1, 2010

Last Updated

December 10, 2010

Record last verified: 2010-12

Locations