Study of Coronary Heart Disease (CHD) & Heart Failure (HF) Risk in Prostate Cancer Patients, Taking Casodex or Not

Prostate Cancer Clinical Trial

Official title:

A Pharmacoepidemiological Study on the Association Between Bicalutamide Treated Prostate Cancer and Risk of Coronary Heart Disease (CHD) and Heart Failure (HF) in the General Practice Research Database (GPRD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688532
• Other study ID #: D6874C00008
• Status: Completed
• Phase: N/A
• First received: May 30, 2008
• Last updated: January 30, 2013
• Start date: December 2007
• Est. completion date: June 2009

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5103
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 84 Years

Eligibility

Inclusion Criteria:

• At least two years enrollment with the general practitioner

Exclusion Criteria:

• Patients with cancer before start date of the study

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary heart disease including acute myocardial infarction and death from CHD		From study start 1 Jan 1999 through 31December 2006
Primary	Heart Failure		From study start 1 Jan 1999 through 31December 2006