European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
PREMISE
A European Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Enzalutamide Treatment in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
1 other identifier
observational
1,763
16 countries
182
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Typical duration for all trials
182 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2015
CompletedFirst Posted
Study publicly available on registry
July 13, 2015
CompletedStudy Start
First participant enrolled
September 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2019
CompletedOctober 21, 2024
April 1, 2019
3.4 years
July 9, 2015
October 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
Time to prostate specific antigen (PSA) progression
up to 18 months
PSA response
up to 18 months
Time to disease progression
up to 18 months
Overall Survival (France only)
up to 18 months
Treatment duration
up to 18 months
- +12 more secondary outcomes
Study Arms (1)
Patients with mCRPC prescribed enzalutamide
Oral
Interventions
Eligibility Criteria
Patients with metastatic castration resistant prostate cancer prescribed enzalutamide as part of standard clinical practice
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Europe Ltd.lead
- Medivation, Inc.collaborator
Study Sites (182)
Site AT43001
Bregenz, 6900, Austria
Site AT43005
Innsbruck, 6020, Austria
Site AT43006
Linz, 4010, Austria
Site AT43004
Vienna, 1090, Austria
Site BL32003
Bonheiden, Antwerpen, 2820, Belgium
Site BL32004
Brasschaat, Antwerpen, 2930, Belgium
Site BL32007
Haine-Saint-Paul, Hainaut, 7100, Belgium
Site BL32008
Aalst, Oost-Vlaanderen, 9300, Belgium
Site BL32009
Ghent, Oost-Vlaanderen, 9000, Belgium
Site BL32010
Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium
Site BL32013
Leuven, Vlaams Brabant, 3000, Belgium
Site BL32005
Kortrijk, West-Vlaanderen, 8500, Belgium
Site BL32001
Brussels, 1070, Belgium
Site BL32011
Brussels, 1200, Belgium
Site BL32012
Hasselt, 3500, Belgium
Site BG35903
Plovdiv, 4000, Bulgaria
Site BG35901
Sofia, 1303, Bulgaria
Site CZ42004
Brno, 656 91, Czechia
Site CZ42007
Jihlava, 586 33, Czechia
Site CZ42003
Nový Jičín, 741 01, Czechia
Site CZ42001
Prague, 140 59, Czechia
Site CZ42006
Prague, 180 81, Czechia
Site DK45003
Aalborg, 9100, Denmark
Site DK45004
Aarhus, 8000, Denmark
Site DK45002
Copenhagen, 2200, Denmark
Site DK45001
Herlev, 2730, Denmark
Site FR33015
Colmar, Alsace, 68024, France
Site FR33003
Strasbourg, Alsace, 67000, France
Site FR33017
Bordeaux, Aquitaine, 33000, France
Site FR33051
Bordeaux, Aquitaine, 33000, France
Site FR33018
Bordeaux, Aquitaine, 33300, France
Site FR33009
Valence, Auvergne-Rhône-Alpes, 26000, France
Site FR33022
Clermont-Ferrand, Auvergne, 63100, France
Site FR33006
Aix-en-Provence, Bouches-du-Rhône, 13617, France
Site FR33027
Marseille, Bouches-du-Rhône, 13005, France
Site FR33041
Marseille, Bouches-du-Rhône, 13286, France
Site FR33069
Saint-Martin-Boulogne, Boulogne-sur-Mer, 62222, France
Site FR33043
Sens, Bourgogne-Franche-Comté, 89100, France
Site FR33026
Brest, Brittany Region, 29229, France
Site FR33004
Saint-Grégoire, Brittany Region, 35760, France
Site FR33025
Vannes, Brittany Region, 56000, France
Site FR33010
Reims, Champagne-Ardenne, 51726, France
Site FR33067
Dijon, Côte-d'Or, 21000, France
Site FR33062
Longjumeau, Essonne, 91164, France
Site FR33033
Évreux, Eure, 27000, France
Site FR33002
Quimper, Finistère, 29000, France
Site FR33040
Toulouse, Haute-Garonne, 31059, France
Site FR33049
Gap, Hautes-Alpes, 05000, France
Site FR33039
Lille, Hauts-de-France, 59037, France
Site FR33042
Suresnes, Hauts-de-Seine, 92151, France
Site FR33020
Tours, Indre-et-Loire, 37044, France
Site FR33060
Grenoble, Isère, 38043, France
Site FR33050
Bézier, Languedoc-Roussillon, 34500, France
Site FR33066
Orléans, Loiret, 45067, France
Site FR33061
Vandœuvre-lès-Nancy, Lorraine, 54519, France
Site FR33065
Agen, Lot-et-Garonne, 47000, France
Site FR33019
Angers, Maine-et-Loire, 49933, France
Site FR33007
Nancy, Meurthe-et-Moselle, 54000, France
Site FR33059
Albi, Midi-Pyrénées, 81000, France
Site FR33021
Coudekerque-Branche, Nord, 59210, France
Site FR33063
Beauvais, Oise, 60000, France
Site FR33016
Saint-Priest-en-Jarez, Pays de la Loire Region, 42271, France
Site FR33070
Amiens, Picardie, 80094, France
Site FR33044
Saint-Quentin, Picardie, 02321, France
Site FR33028
Clermont-Ferrand, Puy-de-Dôme, 63003, France
Site FR33035
Bayonne, Pyrénées-Atlantiques, 64100, France
Site FR33012
Lyon, Rhône, 69009, France
Site FR33030
Lyon, Rhône, 69437, France
Site FR33058
Chalon-Sus-Saone, Saône-et-Loire, 71100, France
Site FR33008
Amiens, Somme, 80000, France
Site FR33032
Amiens, Somme, 80090, France
Site FR33014
Créteil, Val-de-Marne, 94400, France
Site FR33037
Saint-Mandé, Val-de-Marne, 94160, France
Site FR33011
Toulon, Var, 83100, France
Site FR33001
Avignon, Vaucluse, 84918, France
Site FR33046
Arras, 62660, France
Site FR33054
Hyères, 83400, France
Site FR33038
La Chaussée-Saint-Victor, 41260, France
Site FR33057
Paris, 75014, France
Site FR33034
Paris, 75020, France
Site FR33029
Paris, 75475, France
Site FR33064
Paris, 75908, France
Site DE49001
Nürtingen, Baden-Wurttemberg, 72622, Germany
Site DE49016
Wiesbaden, Hesse, 65191, Germany
Site DE49003
Lüneburg, Lower Saxony, 21335, Germany
Site DE49011
Soltau, Lower Saxony, 29614, Germany
Site DE49013
Bonn, North Rhine-Westphalia, 53111, Germany
Site DE49012
Chemnitz, Saxony, 09130, Germany
Site DE49009
Bernburg, Saxony-Anhalt, 06406, Germany
Site DE49015
Kiel, Schleswig-Holstein, 24103, Germany
Site DE49005
Cologne, 50968, Germany
Site DE49006
Rostock, 18107, Germany
Site DE49014
Wuppertal, 42103, Germany
Site DE49010
Würselen, 52146, Germany
Site GC30001
Kifissia, Attica, 14564, Greece
Site GC30013
Athens, 11528, Greece
Site GC30007
Athens, 45001, Greece
Site GC30005
Athens, 45500, Greece
Site GC30010
Athens, 54642, Greece
Site GC30003
Athens, 57001, Greece
Site GC30004
Ioannina, 11525, Greece
Site GC30006
Ioannina, 15126, Greece
Site GC30012
Larissa, 41110, Greece
Site GC30008
Thessaloniki, 11522, Greece
Site GC30002
Thessaloniki, 14564, Greece
Site GC30011
Thessaloniki, 56403, Greece
Site HU36006
Debrecen, Hajdú-Bihar, 4032, Hungary
Site HU36002
Budapest, 1082, Hungary
Site HU36001
Budapest, 1122, Hungary
Site HU36005
Szeged, H-6720, Hungary
Site HU36003
Szombathely, H-9700, Hungary
Site IR35304
Dublin, 24, Ireland
Site IR35302
Dublin, 7, Ireland
Site IR35305
Dublin, 7, Ireland
Site IR35306
Dublin, 8, Ireland
Site IT39001
Meldola, Forlì, 47014, Italy
Site IT39010
Lecco, Lombardy, 23900, Italy
Site IT39009
Rozzano, Milano, 20089, Italy
Site IT39002
Aviano, Pordenone, 33081, Italy
Site IT39013
Candiolo, Torino, 10060, Italy
Site IT39011
Mirano, Venezia, 30035, Italy
Site IT39005
Bari, 70124, Italy
Site IT39012
Catania, 95122, Italy
Site IT39006
Florence, 50134, Italy
Site IT39004
Milan, 20141, Italy
Site IT39017
Milan, 20162, Italy
Site IT39003
Modena, 41124, Italy
Site IT39007
Napoli, 80131, Italy
Site IT39018
Novara, 28100, Italy
Site IT39008
Padua, 35128, Italy
Site IT39015
Palermo, 90146, Italy
Site IT39014
Pisa, 56126, Italy
Site IT39016
Reggio Emilia, 42100, Italy
Site NL31006
Arnhem, 6815 AD, Netherlands
Site NL31007
Breda, 4819 EV, Netherlands
Site NL31005
Doetinchem, 7009 BL, Netherlands
Site NL31008
Helmond, 5707 HA, Netherlands
Site NL31001
Hilversum, 1213 XZ, Netherlands
Site NL31004
Hoofddorp, 2134 TM, Netherlands
Site NL31010
Nieuwegein, 3435 CM, Netherlands
Site NL31003
The Hague, 2545 CH, Netherlands
Site NL31011
Zwolle, 8025 AB, Netherlands
Site PT35101
Porto, 4099-001, Portugal
Site SV38501
Ljubljana, Slovenia
Site ES34007
Zaragoza, Aragon, 50009, Spain
Site ES34012
Zaragoza, Aragon, 50009, Spain
Site ES34008
Guadalajara, Castille-La Mancha, 19002, Spain
Site ES34009
Toledo, Castille-La Mancha, 45004, Spain
Site ES34013
Barcelona, Catalonia, 08036, Spain
Site ES34011
Lleida, Catalonia, 25198, Spain
Site ES34010
Reus, Catalonia, 43204, Spain
Site ES34004
Badajoz, Extremadura, 06002, Spain
Site ES34006
Cáceres, Extremadura, 10003, Spain
Site ES34005
A Coruña, Galicia, 15006, Spain
Site ES34016
Lugo, Galicia, 27003, Spain
Site ES34003
Ourense, Galicia, 32005, Spain
Site ES34001
Santiago de Compostela, Galicia, 15706, Spain
Site ES34017
Vigo, Galicia, 36312, Spain
Site GB44001
Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom
Site GB44012
Torquay, Devon, TQ2 7AA, United Kingdom
Site GB44025
Poole, Dorset, BH15 2JB, United Kingdom
Site GB44026
Blackburn, Lancashire, BB2 3HH, United Kingdom
Site GB44011
Preston, Lancashire, PR2 9HT, United Kingdom
Site GB44004
Boston, Lincolnshire, PE21 9QS, United Kingdom
Site GB44002
Lincoln, Lincolnshire, LN2 5QY, United Kingdom
Site GB44008
Berkshire, Slough, SL2 4HL, United Kingdom
Site GB44013
Weston-super-Mare, Somerset, BS23 4TQ, United Kingdom
Site GB44007
Treliske, Truro, TR1 3LJ, United Kingdom
Site GB44009
Swindon, Wiltshire, SN3 6BB, United Kingdom
Site GB44005
Worcester, Worcestershire, WR5 1DD, United Kingdom
Site GB44023
Birmingham, B15 2TH, United Kingdom
Site GB44010
Brighton, BN2 3EW, United Kingdom
Site GB44016
Derby, DE22 3NE, United Kingdom
Site GB44020
Guildford, GU2 7XX, United Kingdom
Site GB44022
Inverness-shire, IV2 3UJ, United Kingdom
Site GB44024
Leicester, LE1 5WW, United Kingdom
Site GB44003
London, NW1 2BU, United Kingdom
Site GB44017
Newcastle upon Tyne, NE7 7DN, United Kingdom
Site GB44015
Norfolk, PE30 4ET, United Kingdom
Site GB44006
Reading, RG1 5AN, United Kingdom
Site GB44014
Taunton, TA1 5DA, United Kingdom
Site GB44018
Wolverhampton, WV10 0QP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Research Physician
Astellas Pharma Europe Ltd.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2015
First Posted
July 13, 2015
Study Start
September 8, 2015
Primary Completion
February 8, 2019
Study Completion
February 8, 2019
Last Updated
October 21, 2024
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.