Depiction of Prostate Cancer Treatment Alternatives in Gr... | NCT00733213

Studies
Depiction of Prostate Cancer Treatment Alternatives in Greece

NCT00733213

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Oct 14, 2009Estimated

Enrollment

310Estimated

Phase

Not provided

Conditions

Locally Advanced or Metastatic Prostate Cancer.

Interventions

Not provided

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Not provided

Completion Date

Mar 2009Actual

First Submitted Date

Aug 8, 2008

First Submission Date that Met QC Criteria

Aug 11, 2008

First Posted Date

Aug 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2009

Last Update Posted Date

Oct 14, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A retrospective, registry analysis of the socio-economic and demographic characteristics of patients suffering from locally advanced or metastatic prostate cancer, as well as the depiction of the therapeutic algorithms followed in the Greek clinical practice.

Target Group: Patients with locally advanced or metastatic prostate cancer.
The first 10 consecutive patients records that meet the entry criteria.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

310Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients treated by each treatment alternative.		Between 2002 - 2008

Secondary Outcomes

Measure	Description	Time Frame
To depict sociodemographic characteristics and comorbidities.		Between 2002 - 2008

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with Locally advanced or Metastatic Prostate Cancer after 2002.
Patients that received Hormonal therapy.

Exclusion Criteria:

Males that are aged less than 18 years

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Target Group: Patients diagnosed with Locally advanced or Metastatic Prostate Cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Panagiotis Pontikis, MD	AstraZeneca Greece	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Athens			Greece
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided