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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00688532
First received: May 30, 2008
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Coronary heart disease including acute myocardial infarction and death from CHD [ Time Frame: From study start 1 Jan 1999 through 31December 2006 ]
  • Heart Failure [ Time Frame: From study start 1 Jan 1999 through 31December 2006 ]

Enrollment: 5103
Study Start Date: December 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Prostate cancer patients treated with bicalutamide or not
2
General population cohort

  Eligibility

Ages Eligible for Study:   50 Years to 84 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

GPRD containing computerized information entered by general practitioners in the UK

Criteria

Inclusion Criteria:

  • At least two years enrollment with the general practitioner

Exclusion Criteria:

  • Patients with cancer before start date of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688532

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: LA García Rodríguez, MD CEIFE (Centro Español de Investigación Farmacoepidemiológica -Spanish Centre for Pharmacoepidemiologic Research) Almirante
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00688532     History of Changes
Other Study ID Numbers: D6874C00008
Study First Received: May 30, 2008
Last Updated: January 30, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Prostate cancer
pharmacoepidemiology study

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Heart Failure
Prostatic Neoplasms
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013