NCT00688532

Brief Summary

A retrospective cohort study performed in the GPRD,UK. All patients with incident prostate cancer identified between 1 Jan 1999 and 31 Dec 2005 and a frequency-matched cohort of the general population will be followed- up for two outcomes; CHD including acute myocardial infarction or death from coronary heart disease and HF until Dec 31, 2006. Outcomes will be validated through requests to primary care physicians. Incidence rate´ratios of CHD and HF in the two cohorts will be calculated. In the cohort of prostate cancer the relative risk of CHD and HF associated with the use of bicalutamide compared to non-use will be estimated.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
5,103

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

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

December 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

1.5 years

First QC Date

May 30, 2008

Last Update Submit

January 30, 2013

Conditions

Prostate Cancer

Keywords

Prostate cancerpharmacoepidemiology study

Outcome Measures

Primary Outcomes (2)

  • Coronary heart disease including acute myocardial infarction and death from CHD

    From study start 1 Jan 1999 through 31December 2006

  • Heart Failure

    From study start 1 Jan 1999 through 31December 2006

Study Arms (2)

1

Prostate cancer patients treated with bicalutamide or not

2

General population cohort

Eligibility Criteria

Age50 Years - 84 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

GPRD containing computerized information entered by general practitioners in the UK

You may qualify if:

  • At least two years enrollment with the general practitioner

You may not qualify if:

  • Patients with cancer before start date of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • LA García Rodríguez, MD

    CEIFE (Centro Español de Investigación Farmacoepidemiológica -Spanish Centre for Pharmacoepidemiologic Research) Almirante

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 3, 2008

Study Start

December 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 31, 2013

Record last verified: 2013-01