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NCT Number: NCT03243604

cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study

Abiraterone associated with prednisone is used in prostate cancer. Abiraterone is a selective small-molecule inhibiting cytochrome P450 17A1 (CYP17A1), a key enzyme in androgen synthesis.

CYP17A inhibition is also responsible for mineral corticosteroid related adverse events as hypokaliemia, fluid retention, and hypertension. Primary hyperaldosteronism is associated with cardiovascular toxicities such as atrial fibrillation and cardiac failure. Other androgen-deprivation therapies are not associated with increased mineral corticosteroid level.

This study investigates reports of cardiovascular toxicities for treatment including L02 (sex hormones used in treatment of neoplastic diseases), and G03 (sex hormones) used in prostate cancer in the French pharmacovigilance database and in the EudraCT database.

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Key information

Conditions

Arrhythmias, Cardiac Atrial Fibrillation Atrial Fibrillation and Flutter Cardiac Conduction System Disease Cardiac Failure Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Tachycardia Tachycardia, Supraventricular Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière

Paris, Île-de-France Region, 75013, France

About this study

Due to its peculiar pharmacology, abiraterone is potentially associated with more cardiotoxicity as compared to other androgen-deprivation therapies. This study investigates the main characteristics of patients affected by cardiovascular side effects of which supraventricular arrhythmias (including atrial fibrillation, atrial flutter, supraventricular tachycardia), and cardiac failure imputed to drugs classified as L02, and G03 according to anatomical therapeutic chemical (ATC) classification. A causality assessment according to the World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) is systematically applied.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Case reported in the French pharmacovigilance database from 01/01/1985 to 16/05/2017
  • Case reported in the EudraCT database to May 2017
  • Adverse event reported were including the MedDRA terms: SOC Cardiac Disorders; SOC Vascular Disorders; HLT Death, Sudden Death; HLGT Water, electrolyte and mineral investigations; HLGT Cardiac and vascular investigations (excl enzyme tests); and PT Syncope.
  • Patients treated with hormonal therapies included in the ATC L02, and G03

Exclusion criteria

  • Chronology not compatible between the drug and the toxicity

Treatment and study plan

L02 (sex hormones used in treatment of neoplastic diseases) and G03 (sex hormones)

Drug

Androgen-deprivation therapies including L02 (sex hormones used in treatment of neoplastic diseases), and G03 (sex hormones)

Primary outcomes

  1. Analysis of disproportionality of reports for cardiotoxicity associated with abiraterone as compared to enzalutamide by performing a case- non-case study

    Time frame: 2 months

    Analysis of disproportionality of reports for cardiotoxicity associated with abiraterone as compared to enzalutamide by performing a case- non-case study

Secondary outcomes

  1. Compare the reporting of suspected drug-induced supraventricular arrhythmias with abiraterone as compared to enzalutamide by performing a disproportionality analysis

    Time frame: 2 months

    Compare the reporting of suspected drug-induced supraventricular arrhythmias with abiraterone as compared to enzalutamide by performing a disproportionality analysis

  2. Compare the reporting of drug-induced cardiac failure with abiraterone as compared to enzalutamide by performing a disproportionality analysis

    Time frame: 2 months

    Compare the reporting of drug-induced cardiac failure with abiraterone as compared to enzalutamide by performing a disproportionality analysis

  3. Compare the reporting of drug-induced cardiac failure and/or supraventricular arrhythmias with abiraterone as compared to other androgen-deprivation therapies by performing a disproportionality analysis

    Time frame: 2 months

    Compare the reporting of drug-induced cardiac failure and/or supraventricular arrhythmias with abiraterone as compared to other androgen-deprivation therapies by performing a disproportionality analysis

  4. Description of other mineralocorticoid related adverse events (hypokaliemia, fluid retention, and hypertension) when the cardio toxicity occurs

    Time frame: 2 months

    Description of other mineralocorticoid related adverse events (hypokaliemia, fluid retention, and hypertension) when the cardio toxicity occurs

  5. Description of the population of patients having a cardio-vascular adverse event

    Time frame: 2 months

    Description of the population of patients having a cardio-vascular adverse event

  6. Description of the duration of treatment when the toxicity happens (role of cumulative dose)

    Time frame: 2 months

    Description of the duration of treatment when the toxicity happens (role of cumulative dose)

  7. Description of the drug-drug interactions associated with adverse events

    Time frame: 2 months

    Description of the drug-drug interactions associated with adverse events

  8. Causality assessment of reported cardiovascular events according to the WHO-UMC system

    Time frame: 2 months

    Causality assessment of reported cardiovascular events according to the WHO-UMC system

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Official study title

Cardiotoxicity of Abiraterone in the National French Pharmacovigilance Database and in the European Clinical Trials Database (EudraCT)

Acronym: ARBITRAGE

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2017
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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