Study identification

EU PAS number

EUPAS1000000593

Study ID

1000000593

Official title and acronym

Therapy of metastatic castration-resistant prostate cancer with Talazoparib + Enzalutamide under real world conditions in Germany – an observational medical chart review study (PROTEGE study)

DARWIN EU® study

No

Study countries

Germany

Study description

This is a non-interventional, observational, retrospective, multicenter study with secondary data collection and human review of medical charts in patients with mCRPC, who received talazoparib + enzalutamide under daily routine conditions in hospitals or practices in Germany.
The primary objective of the study is to describe the effectiveness of talazoparib + enzalutamide in mCRPC patients treated in real-world clinical settings in Germany.
For patients aged 18 and older with a confirmed diagnosis of mCRPC, whose treatment with talazoparib and enzalutamide was already initiated according to routine clinical practice, EHR data will be extracted retrospectively at multiple timepoints for up to 24 months after index date (date of talazoparib + enzalutamide initiation), or until loss to follow up, death, or study termination, whichever occurs the earliest.

Study status

Planned
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
GermanOncology GmbH

Contact details

Giovanni Zanotti

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc.
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable