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.
Study Type
OBSERVATIONAL
Enrollment
1,763
oral
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.
Time frame: up to 18 months
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.
Time frame: up to 18 months
PSA response
Time frame: 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.
Time frame: up to 18 months
Overall Survival (France only)
Time from initiation of enzalutamide to death or patient survival at the end of the study.
Time frame: up to 18 months
Treatment duration
Time frame: up to 18 months
Reason for initiation of treatment with enzalutamide
Time frame: up to 18 months
Reason for enzalutamide discontinuation
Time frame: up to 18 months
Subsequent anti-neoplastic therapy for mCRPC
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Site AT43001
Bregenz, Austria
Site AT43005
Innsbruck, Austria
Site AT43006
Linz, Austria
Site AT43004
Vienna, 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
Ghent, Oost-Vlaanderen, Belgium
Site BL32010
Sint-Niklaas, Oost-Vlaanderen, Belgium
...and 172 more locations
Time frame: up to 18 months
Time to opiate use
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 18 months
Number of participants hospitalized
Time frame: up to 18 months
Number of visits to health care professionals
Time frame: up to 18 months
Safety assessed by reported adverse events
Time frame: up to 18 months
Safety assessed by modification of treatment with enzalutamide as a response to adverse events
Time frame: up to 18 months
Number of Deaths
Deaths defined as deaths due to any cause
Time frame: up to 18 months