European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1763
- 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)
-
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 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.
PSA response up to 18 months 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 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) 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 BL32001
🇧🇪Brussels, Belgium
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 BL32011
🇧🇪Bruxelles, Belgium
Site BL32012
🇧🇪Hasselt, Belgium
Site BG35903
🇧🇬Plovdiv, Bulgaria
Site BG35901
🇧🇬Sofia, Bulgaria
Site FR33025
🇫🇷Vannes, Bretagne, France
Site FR33033
🇫🇷Evreux, Eure, France
Site FR33002
🇫🇷Quimper, Finistère, France
Site FR33049
🇫🇷Gap, Hautes-Alpes, France
Site FR33016
🇫🇷Saint-Priest-en-Jarez, Loire, France
Site FR33065
🇫🇷Agen, Lot-et-Garonne, France
Site FR33020
🇫🇷Tours, Indre-et-Loire, France
Site IR35302
🇮🇪Dublin, Ireland
Site IR35305
🇮🇪Dublin, Ireland
Site GC30006
🇬🇷Ioannina, Greece
Site HU36001
🇭🇺Budapest, Hungary
Site GB44005
🇬🇧Worcester, Worcestershire, United Kingdom
Site AT43001
🇦🇹Bregenz, Austria
Site AT43005
🇦🇹Innsbruck, Austria
Site AT43006
🇦🇹Linz, Austria
Site BL32010
🇧🇪Sint-Niklaas, Oost-Vlaanderen, Belgium
Site BL32013
🇧🇪Leuven, Vlaams Brabant, Belgium
Site BL32009
🇧🇪Gent, Oost-Vlaanderen, Belgium
Site BL32005
🇧🇪Kortrijk, West-Vlaanderen, Belgium
Site CZ42001
🇨🇿Praha, Czechia
Site CZ42004
🇨🇿Brno, Czechia
Site CZ42007
🇨🇿Jihlava, Czechia
Site CZ42006
🇨🇿Praha, Czechia
Site CZ42003
🇨🇿Novy Jicin, Czechia
Site FR33015
🇫🇷Colmar, Alsace, France
Site FR33017
🇫🇷Bordeaux, Aquitaine, France
Site FR33003
🇫🇷Strasbourg, Alsace, France
Site FR33051
🇫🇷Bordeaux, Aquitaine, France
Site FR33022
🇫🇷Clermont Ferrand, Auvergne, France
Site FR33018
🇫🇷Bordeaux, Aquitaine, France
Site FR33069
🇫🇷Saint-Martin-Boulogne, Boulogne-sur-Mer, France
Site FR33026
🇫🇷Brest Cedex 2, Bretagne, France
Site FR33043
🇫🇷Sens, Bourgogne, France
Site FR33004
🇫🇷Saint Grégoire, Bretagne, France
Site FR33062
🇫🇷Longjumeau, Essonne, France
Site FR33040
🇫🇷Toulouse, Haute-Garonne, France
Site FR33042
🇫🇷Suresnes, Hauts-de-Seine, France
Site FR33060
🇫🇷Grenoble, Isère, France
Site FR33066
🇫🇷Orléans, Loiret, France
Site FR33050
🇫🇷Bézier, Languedoc-Roussillon, France
Site FR33061
🇫🇷Vandœuvre-lès-Nancy, Lorraine, France
Site FR33007
🇫🇷Nancy, Meurthe-et-Moselle, France
Site FR33059
🇫🇷Albi, Midi-Pyrénées, France
Site FR33021
🇫🇷Coudekerque-Branche Cedex, Nord, France
Site FR33039
🇫🇷Lille, Nord-Pas-de-Calais, France
Site FR33063
🇫🇷Beauvais, Oise, France
Site IT39010
🇮🇹Lecco, Lombardia, Italy
Site FR33006
🇫🇷Aix en Provence, Bouches-du-Rhône, France
Site FR33041
🇫🇷Marseille, Bouches-du-Rhône, France
Site FR33027
🇫🇷Marseille, Bouches-du-Rhône, France
Site FR33019
🇫🇷Angers, Maine-et-Loire, France
Site FR33067
🇫🇷Dijon, Côte-d'Or, France
Site DK45003
🇩🇰Aalborg, Denmark
Site DK45004
🇩🇰Aarhus, Denmark
Site DK45002
🇩🇰Copenhagen, Denmark
Site DK45001
🇩🇰Herlev, Denmark
Site FR33010
🇫🇷Reims Cedex, Champagne-Ardenne, France
Site FR33001
🇫🇷Avignon Cedex 9, Vaucluse, France
Site GC30001
🇬🇷Kifisia, Attiki, Greece
Site GC30004
🇬🇷Ioannina, Greece
Site GC30008
🇬🇷Thessaloniki, Greece
Site GC30002
🇬🇷Thessaloniki, Greece
Site HU36003
🇭🇺Szombathely, Hungary
Site FR33070
🇫🇷Amiens, Picardie, France
Site FR33038
🇫🇷La Chaussée-Saint-Victor, France
Site FR33028
🇫🇷Clermont Ferrand Cedex 1, Puy-de-Dôme, France
Site FR33058
🇫🇷Chalon-Sus-Saone, Saône-et-Loire, France
Site FR33008
🇫🇷Amiens, Somme, France
Site FR33037
🇫🇷Saint Mandé, Val-de-Marne, France
Site FR33012
🇫🇷Lyon Cedex 9, Rhône, France
Site FR33030
🇫🇷Lyon, Rhône, France
Site FR33032
🇫🇷Amiens, Somme, France
Site FR33014
🇫🇷Créteil, Val-de-Marne, France
Site FR33011
🇫🇷Toulon, Var, France
Site FR33044
🇫🇷Saint Quentin Cedex, Picardie, France
Site FR33009
🇫🇷Valence, Rhône-Alpes, France
Site FR33054
🇫🇷Hyères, France
Site FR33035
🇫🇷Bayonne, Pyrénées-Atlantiques, France
Site FR33046
🇫🇷Arras, France
Site FR33034
🇫🇷Paris, France
Site FR33057
🇫🇷Paris, France
Site FR33029
🇫🇷Paris, France
Site DE49001
🇩🇪Nürtingen, Baden-Württemberg, Germany
Site SV38501
🇸🇮Ljubljana, Slovenia
Site GC30007
🇬🇷Athens, Greece
Site IT39005
🇮🇹Bari, Italy
Site FR33064
🇫🇷Paris, France
Site DE49016
🇩🇪Wiesbaden, Hessen, Germany
Site DE49005
🇩🇪Köln, Germany
Site DE49012
🇩🇪Chemnitz, Sachsen, Germany
Site GC30013
🇬🇷Athens, Greece
Site GC30005
🇬🇷Athens, Greece
Site GC30010
🇬🇷Athens, Greece
Site GC30003
🇬🇷Athens, Greece
Site DE49010
🇩🇪Würselen, Germany
Site DE49015
🇩🇪Kiel, Schleswig-Holstein, Germany
Site DE49003
🇩🇪Lüneburg, Niedersachsen, Germany
Site DE49011
🇩🇪Soltau, Niedersachsen, Germany
Site DE49013
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Site DE49009
🇩🇪Bernburg, Sachsen-Anhalt, Germany
Site DE49006
🇩🇪Rostock, Germany
Site DE49014
🇩🇪Wuppertal, Germany
Site GC30012
🇬🇷Larissa, Greece
Site GC30011
🇬🇷Thessaloniki, Greece
Site GB44012
🇬🇧Torquay, Devon, United Kingdom
Site HU36006
🇭🇺Debrecen, Hajdú-Bihar, Hungary
Site HU36005
🇭🇺Szeged, Hungary
Site IR35304
🇮🇪Dublin, Ireland
Site IT39002
🇮🇹Aviano, Pordenone, Italy
Site IT39011
🇮🇹Mirano, Venezia, Italy
Site IT39008
🇮🇹Padova, Italy
Site HU36002
🇭🇺Budapest, Hungary
Site IR35306
🇮🇪Dublin, Ireland
Site IT39001
🇮🇹Meldola, Forlì, Italy
Site IT39009
🇮🇹Rozzano, Milano, Italy
Site IT39013
🇮🇹Candiolo, Torino, Italy
Site IT39012
🇮🇹Catania, Italy
Site IT39006
🇮🇹Firenze, Italy
Site IT39004
🇮🇹Milano, Italy
Site IT39017
🇮🇹Milano, Italy
Site IT39003
🇮🇹Modena, Italy
Site IT39007
🇮🇹Napoli, Italy
Site IT39018
🇮🇹Novara, Italy
Site NL31007
🇳🇱Breda, Netherlands
Site NL31008
🇳🇱Helmond, Netherlands
Site PT35101
🇵🇹Porto, Portugal
Site GB44007
🇬🇧Treliske, Truro, United Kingdom
Site ES34010
🇪🇸Reus, Cataluña, Spain
Site ES34017
🇪🇸Vigo, Galicia, Spain
Site ES34008
🇪🇸Guadalajara, Castilla La Mancha, Spain
Site ES34007
🇪🇸Zaragoza, Aragón, Spain
Site NL31005
🇳🇱Doetinchem, Netherlands
Site NL31010
🇳🇱Nieuwegein, Netherlands
Site GB44001
🇬🇧Aberdeen, Aberdeenshire, United Kingdom
Site GB44025
🇬🇧Poole, Dorset, United Kingdom
Site GB44002
🇬🇧Lincoln, Lincolnshire, United Kingdom
Site GB44008
🇬🇧Berkshire, Slough, United Kingdom
Site GB44013
🇬🇧Weston-super-Mare, Somerset, United Kingdom
Site IT39015
🇮🇹Palermo, Italy
Site IT39016
🇮🇹Reggio Emilia, Italy
Site GB44020
🇬🇧Guildford, United Kingdom
Site GB44017
🇬🇧Newcastle upon Tyne, United Kingdom
Site GB44006
🇬🇧Reading, United Kingdom
Site GB44003
🇬🇧London, United Kingdom
Site ES34016
🇪🇸Lugo, Galicia, Spain
Site ES34004
🇪🇸Badajoz, Extremadura, Spain
Site ES34012
🇪🇸Zaragoza, Aragón, Spain
Site NL31011
🇳🇱Zwolle, Netherlands
Site IT39014
🇮🇹Pisa, Italy
Site ES34011
🇪🇸Lleida, Cataluña, Spain
Site ES34013
🇪🇸Barcelona, Cataluña, Spain
Site ES34006
🇪🇸Cáceres, Extremadura, Spain
Site NL31006
🇳🇱Arnhem, Netherlands
Site NL31003
🇳🇱Den Haag, Netherlands
Site NL31004
🇳🇱Hoofddorp, Netherlands
Site GB44011
🇬🇧Preston, Lancashire, United Kingdom
Site ES34003
🇪🇸Orense, Galicia, Spain
Site ES34005
🇪🇸A Coruña, Galicia, Spain
Site NL31001
🇳🇱Hilversum, Netherlands
Site GB44004
🇬🇧Boston, Lincolnshire, United Kingdom
Site GB44015
🇬🇧Norfolk, United Kingdom
Site ES34001
🇪🇸Santiago de Compostela, Galicia, Spain
Site GB44026
🇬🇧Blackburn, Lancashire, United Kingdom
Site ES34009
🇪🇸Toledo, Castilla La Mancha, Spain
Site GB44009
🇬🇧Swindon, Wiltshire, United Kingdom
Site GB44023
🇬🇧Birmingham, United Kingdom
Site GB44010
🇬🇧Brighton, United Kingdom
Site GB44016
🇬🇧Derby, United Kingdom
Site GB44022
🇬🇧Inverness-shire, United Kingdom
Site GB44024
🇬🇧Leicester, United Kingdom
Site GB44014
🇬🇧Taunton, United Kingdom
Site GB44018
🇬🇧Wolverhampton, United Kingdom