European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC) (PREMISE)

Astellas

Status: Completed

Conditions: Metastatic Castration Resistant Prostate Cancer

Treatments: Drug: enzalutamide

Study type: Observational

Funder types: Industry

Identifiers

NCT02495974

9785-MA-1002

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) in the clinical practice setting as measured by time to treatment failure defined as the time from baseline (treatment initiation) to treatment discontinuation of enzalutamide for any reason including disease progression, skeletal related events, treatment toxicity, patient preference, or death.

Enrollment: 1,763 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men with mCRPC who have been prescribed enzalutamide as part of standard clinical practice
• Germany only: Enzalutamide will be prescribed according to the current SmPC (Summary of Product Characteristics)

Exclusion criteria

• Patients with the following will be excluded from study participation in France only:

  • Patients who have previously been treated with abiraterone acetate (Zytiga®) after docetaxel chemotherapy.
  • Patients who have previously been treated with cabazitaxel (Jevtana®)
  • Patients who have previously been treated with Xtandi®
  • Patients taking part in an interventional clinical trial

Trial design

1,763 participants in 1 patient group

Patients with mCRPC prescribed enzalutamide

Description:

Oral

Treatment:

Drug: enzalutamide