Observational Retrospective Trial on Sequential Hormonal... | NCT00668083

Studies
Observational Retrospective Trial on Sequential Hormonal Therapy in Patients With Prostate Cancer

NCT00668083

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 10, 2010Estimated

Enrollment

214Estimated

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Not provided

Countries

Italy

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

Dec 2010

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

Sep 2007

Primary Completion Date

Oct 2007Actual

Completion Date

Jul 2008Actual

First Submitted Date

Apr 24, 2008

First Submission Date that Met QC Criteria

Apr 27, 2008

First Posted Date

Apr 28, 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

Dec 9, 2010

Last Update Posted Date

Dec 10, 2010Estimated

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

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

214Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hormonal sensitivity to second line treatment for CaP after Bicalutamide		six months

Secondary Outcomes

Measure	Description	Time Frame
median duration of second and third line treatments;		six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

non metastatic Prostate Cancer
previous treatment with bicalutamide 150mg
biochemical relapse/progression

Exclusion Criteria:

use of other treatments for Prostate Cancer

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

THIS IS A RETROSPECTIVE TRIAL THEREFORE CLINICAL DATA ARE FROM ARCHIVED CLINICAL RECORD OF PATIENTS WHO WERE ADMITTED IN THE HOSPITAL.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Davide Meani, MD	AstraZeneca Medical Dept	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Acquaviva delle Fonti			Italy
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

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