NCT03243604

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,717

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

May 16, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

July 20, 2017

Last Update Submit

October 17, 2018

Conditions

Arrhythmias, CardiacAtrial Fibrillation and FlutterTachycardia, SupraventricularCardiac Failure

Keywords

Cardiotoxicityabiraterone acetateandrogen antagonist

Outcome Measures

Primary Outcomes (1)

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

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

    2 months

Secondary Outcomes (8)

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

    2 months

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

    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

    2 months

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

    2 months

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

    2 months

  • +3 more secondary outcomes

Interventions

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)

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population is selected in the French pharmacovigilance database and EudraCT database from 01/01/1985 to May 2017 and included patients treated with hormonal therapies included in the ATC L02, and G03

You may qualify if:

  • 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

You may not qualify if:

  • Chronology not compatible between the drug and the toxicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Arrhythmias, CardiacAtrial FibrillationTachycardia, SupraventricularHeart FailureCardiotoxicity

Interventions

Gonadal Steroid Hormones

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardiaCardiac Conduction System DiseaseDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Gonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 20, 2017

First Posted

August 9, 2017

Study Start

May 16, 2017

Primary Completion

July 13, 2017

Study Completion

July 13, 2017

Last Updated

October 18, 2018

Record last verified: 2018-10

Locations

FR(1)