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

Study Overview
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Brief Summary
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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.

Official Title
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A European Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Enzalutamide Treatment in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Conditions
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Metastatic Castration Resistant Prostate Cancer

Intervention / Treatment
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* Drug: enzalutamide


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with mCRPC prescribed enzalutamide<br>Oral | Drug: enzalutamide<br>* oral<br>* Other names: Xtandi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment failure (TTF) | 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. | up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to prostate specific antigen (PSA) progression | 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. | up to 18 months | 
| PSA response |  | up to 18 months | 
| Time to disease progression | Time from initiation of enzalutamide to the date of radiographic progression, PSA progression or clinical progression according to the investigator's assessment. | up to 18 months | 
| Overall Survival (France only) | Time from initiation of enzalutamide to death or patient survival at the end of the study. | up to 18 months | 
| 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 | 
| Subsequent anti-neoplastic therapy for mCRPC |  | up to 18 months | 
| Time to opiate use |  | up to 18 months | 
| Pain assessed by Brief Pain Inventory Short Form (BPI-SF) | 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. | up to 18 months | 
| Quality of life of participants assessed using EQ-5D-5L | 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. | up to 18 months | 
| Quality of life of participants assessed using FACT-P | 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. | up to 18 months | 
| 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 | Deaths defined as deaths due to any cause | up to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xtandi, Enzalutamide, Prostate cancer, Metastatic castration resistant prostate cancer