Study identification

EU PAS number

EUPAS104771

Study ID

105061

Official title and acronym

An Observational Study to Compare cardiovascular related hospitalization in chemo-naïve Patients with Metastatic Castration Resistant Prostate Cancer, treated with Enzalutamide or Abiraterone in daily practice in Germany (AVENGER)

DARWIN EU® study

No

Study countries

Germany

Study description

This observational study will be based on anonymized German claims data provided by two German health insurance funds. The primary objective of the study is to analyze and compare the risk of cardiovascular (CV) events in chemotherapy-naïve patients with metastatic castration resistant prostate cancer (mCRPC) who initiated treatment with enzalutamide or abiraterone. The secondary objectives of this study are to: • Analyze and compare the CV event rate (including recurrent events) in chemotherapy-naïve patients with mCRPC who initiated treatment with enzalutamide or abiraterone • Describe and compare characteristics of chemotherapy-naïve patients with mCRPC initiating treatment with enzalutamide or abiraterone • Describe treatment sequences and durations of treatments following enzalutamide or abiraterone initiation in chemotherapy-naïve patients with mCRPC

Study status

Finalised
Research institutions and networks

Institutions

A Cytel company

Contact details

Müller Sabrina

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Europe Ltd.
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable