Influence of Hormone Therapy on Heart Attack Incidence in... | NCT00651222

Studies
Influence of Hormone Therapy on Heart Attack Incidence in Men Undergoing Prostate Brachytherapy

NCT00651222

Sponsor

Prostate Cancer Foundation of Chicago

Status

Completed

Last Update Posted

Apr 2, 2008Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Prostate Cancer
Cardiovascular Death

Interventions

No intervention was required

Countries

United States

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

Mar 2008

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 31, 2008

First Submission Date that Met QC Criteria

Mar 31, 2008

First Posted Date

Apr 2, 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

Mar 31, 2008

Last Update Posted Date

Apr 2, 2008Estimated

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

The purpose of this study is to review cause of death in patients undergoing prostate brachytherapy at a single institution. Furthermore, we are analyzing patients undergoing androgen deprivation therapy and whether or not this contributed to cardiovascular deaths, specifically myocardial infarction.

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

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		All deceased patients who underwent brachytherapy at Chicago Prostate Center between 10/14/1997 and 6/15/2007	Other: No intervention was required

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention was required	Other	Death records were reviewed, therefore, there was no intervention	1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Deceased anytime after prostate brachytherapy treatment

Exclusion Criteria:

Patients whose cause of death was unable to be determined

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

Prostate cancer patients treated with prostate brachytherapy at an ambulatory surgery center

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Chicago Prostate Center		Westmont	Illinois	60559	United States

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