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

Completed

• Conditions: Metastatic Castration Resistant Prostate Cancer
• Interventions: Drug: enzalutamide

• Registration Number: NCT02495974
• Lead Sponsor: Astellas Pharma Europe Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-09
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-13
• Study Start: 2015-09-08
• Primary Completion: 2019-02-08
• Study Completion: 2019-02-08
• Status Verified: 2019-04
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1763

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with mCRPC prescribed enzalutamide	enzalutamide	Oral

Primary Outcome Measures

Name	Time	Method
Time to treatment failure (TTF)	up to 18 months	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.

Secondary Outcome Measures

Name	Time	Method
PSA response	up to 18 months
Subsequent anti-neoplastic therapy for mCRPC	up to 18 months
Time to opiate use	up to 18 months
Time to prostate specific antigen (PSA) progression	up to 18 months	Time from initiation of enzalutamide to the date of PSA progression. PSA progression is defined as a PSA rise of greater than or equal to 25% and an absolute increase of greater than or equal to 2 ng/mL.
Time to disease progression	up to 18 months	Time from initiation of enzalutamide to the date of radiographic progression, PSA progression or clinical progression according to the investigator's assessment.
Overall Survival (France only)	up to 18 months	Time from initiation of enzalutamide to death or patient survival at the end of the study.
Treatment duration	up to 18 months
Reason for initiation of treatment with enzalutamide	up to 18 months
Reason for enzalutamide discontinuation	up to 18 months
Pain assessed by Brief Pain Inventory Short Form (BPI-SF)	up to 18 months	The questionnaire is a patient self-rating scale assessing the level of pain, effect of the pain on activities of daily living, and analgesic use.
Quality of life of participants assessed using EQ-5D-5L	up to 18 months	EuroQol5 dimension 5 level health state utility index - 5L (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome. It is designed for self-completion by respondents comprising the following dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Quality of life of participants assessed using FACT-P	up to 18 months	Functional Assessment of Cancer Therapy - Prostate (FACT-P) is a self reported instrument designed to assess patient function in physical, social/family, emotional, and functional well-being and further assesses items for prostate-related symptoms.
Number of participants hospitalized	up to 18 months
Number of visits to health care professionals	up to 18 months
Safety assessed by reported adverse events	up to 18 months
Safety assessed by modification of treatment with enzalutamide as a response to adverse events	up to 18 months
Number of Deaths	up to 18 months	Deaths defined as deaths due to any cause

Trial Locations

Locations (182)

Site AT43001; 🇦🇹 Bregenz, Austria

Site AT43005; 🇦🇹 Innsbruck, Austria

Site AT43006; 🇦🇹 Linz, Austria

Site AT43004; 🇦🇹 Wien, Austria

Site BL32003; 🇧🇪 Bonheiden, Antwerpen, Belgium

Site BL32004; 🇧🇪 Brasschaat, Antwerpen, Belgium

Site BL32007; 🇧🇪 Haine-Saint-Paul, Hainaut, Belgium

Site BL32008; 🇧🇪 Aalst, Oost-Vlaanderen, Belgium

Site BL32009; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

Site BL32010; 🇧🇪 Sint-Niklaas, Oost-Vlaanderen, Belgium

Scroll for more (172 remaining)