Clinical trial NCT02495974: European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Official title: A European Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Enzalutamide Treatment in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Castration Resistant Prostate Cancer
Keywords: Xtandi
Enzalutamide
Prostate cancer
Metastatic castration resistant prostate cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2015-07-13
Enrollment: 1763
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic castration resistant prostate cancer prescribed enzalutamide as part of standard clinical practice

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to treatment failure (TTF)
timeFrame: up to 18 months
Secondary outcomes:
measure: Time to prostate specific antigen (PSA) progression
timeFrame: up to 18 months
measure: PSA response
timeFrame: up to 18 months
measure: Time to disease progression
timeFrame: up to 18 months
measure: Overall Survival (France only)
timeFrame: up to 18 months
measure: Treatment duration
timeFrame: up to 18 months
measure: Reason for initiation of treatment with enzalutamide
timeFrame: up to 18 months
measure: Reason for enzalutamide discontinuation
timeFrame: up to 18 months
measure: Subsequent anti-neoplastic therapy for mCRPC
timeFrame: up to 18 months
measure: Time to opiate use
timeFrame: up to 18 months
measure: Pain assessed by Brief Pain Inventory Short Form (BPI-SF)
timeFrame: up to 18 months
measure: Quality of life of participants assessed using EQ-5D-5L
timeFrame: up to 18 months
measure: Quality of life of participants assessed using FACT-P
timeFrame: up to 18 months
measure: Number of participants hospitalized
timeFrame: up to 18 months
measure: Number of visits to health care professionals
timeFrame: up to 18 months
measure: Safety assessed by reported adverse events
timeFrame: up to 18 months
measure: Safety assessed by modification of treatment with enzalutamide as a response to adverse events
timeFrame: up to 18 months
measure: Number of Deaths
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Bregenz
country: Austria
facility: Site AT43001
city: Innsbruck
country: Austria
facility: Site AT43005
city: Linz
country: Austria
facility: Site AT43006
city: Wien
country: Austria
facility: Site AT43004
city: Bonheiden
country: Belgium
facility: Site BL32003
state: Antwerpen
city: Brasschaat
country: Belgium
facility: Site BL32004
state: Antwerpen
city: Haine-Saint-Paul
country: Belgium
facility: Site BL32007
state: Hainaut
city: Aalst
country: Belgium
facility: Site BL32008
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: Site BL32009
state: Oost-Vlaanderen
city: Sint-Niklaas
country: Belgium
facility: Site BL32010
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Site BL32013
state: Vlaams Brabant
city: Kortrijk
country: Belgium
facility: Site BL32005
state: West-Vlaanderen
city: Brussels
country: Belgium
facility: Site BL32001
city: Bruxelles
country: Belgium
facility: Site BL32011
city: Hasselt
country: Belgium
facility: Site BL32012
city: Plovdiv
country: Bulgaria
facility: Site BG35903
city: Sofia
country: Bulgaria
facility: Site BG35901
city: Brno
country: Czechia
facility: Site CZ42004
city: Jihlava
country: Czechia
facility: Site CZ42007
city: Novy Jicin
country: Czechia
facility: Site CZ42003
city: Praha
country: Czechia
facility: Site CZ42001
city: Praha
country: Czechia
facility: Site CZ42006
city: Aalborg
country: Denmark
facility: Site DK45003
city: Aarhus
country: Denmark
facility: Site DK45004
city: Copenhagen
country: Denmark
facility: Site DK45002
city: Herlev
country: Denmark
facility: Site DK45001
city: Colmar
country: France
facility: Site FR33015
state: Alsace
city: Strasbourg
country: France
facility: Site FR33003
state: Alsace
city: Bordeaux
country: France
facility: Site FR33017
state: Aquitaine
city: Bordeaux
country: France
facility: Site FR33051
state: Aquitaine
city: Bordeaux
country: France
facility: Site FR33018
state: Aquitaine
city: Clermont Ferrand
country: France
facility: Site FR33022
state: Auvergne
city: Aix en Provence
country: France
facility: Site FR33006
state: Bouches-du-Rhône
city: Marseille
country: France
facility: Site FR33027
state: Bouches-du-Rhône
city: Marseille
country: France
facility: Site FR33041
state: Bouches-du-Rhône
city: Saint-Martin-Boulogne
country: France
facility: Site FR33069
state: Boulogne-sur-Mer
city: Sens
country: France
facility: Site FR33043
state: Bourgogne
city: Brest Cedex 2
country: France
facility: Site FR33026
state: Bretagne
city: Saint Grégoire
country: France
facility: Site FR33004
state: Bretagne
city: Vannes
country: France
facility: Site FR33025
state: Bretagne
city: Reims Cedex
country: France
facility: Site FR33010
state: Champagne-Ardenne
city: Dijon
country: France
facility: Site FR33067
state: Côte-d'Or
city: Longjumeau
country: France
facility: Site FR33062
state: Essonne
city: Evreux
country: France
facility: Site FR33033
state: Eure
city: Quimper
country: France
facility: Site FR33002
state: Finistère
city: Toulouse
country: France
facility: Site FR33040
state: Haute-Garonne
city: Gap
country: France
facility: Site FR33049
state: Hautes-Alpes
city: Suresnes
country: France
facility: Site FR33042
state: Hauts-de-Seine
city: Tours
country: France
facility: Site FR33020
state: Indre-et-Loire
city: Grenoble
country: France
facility: Site FR33060
state: Isère
city: Bézier
country: France
facility: Site FR33050
state: Languedoc-Roussillon
city: Orléans
country: France
facility: Site FR33066
state: Loiret
city: Saint-Priest-en-Jarez
country: France
facility: Site FR33016
state: Loire
city: Vandœuvre-lès-Nancy
country: France
facility: Site FR33061
state: Lorraine
city: Agen
country: France
facility: Site FR33065
state: Lot-et-Garonne
city: Angers
country: France
facility: Site FR33019
state: Maine-et-Loire
city: Nancy
country: France
facility: Site FR33007
state: Meurthe-et-Moselle
city: Albi
country: France
facility: Site FR33059
state: Midi-Pyrénées
city: Lille
country: France
facility: Site FR33039
state: Nord-Pas-de-Calais
city: Coudekerque-Branche Cedex
country: France
facility: Site FR33021
state: Nord
city: Beauvais
country: France
facility: Site FR33063
state: Oise
city: Amiens
country: France
facility: Site FR33070
state: Picardie
city: Saint Quentin Cedex
country: France
facility: Site FR33044
state: Picardie
city: Clermont Ferrand Cedex 1
country: France
facility: Site FR33028
state: Puy-de-Dôme
city: Bayonne
country: France
facility: Site FR33035
state: Pyrénées-Atlantiques
city: Valence
country: France
facility: Site FR33009
state: Rhône-Alpes
city: Lyon Cedex 9
country: France
facility: Site FR33012
state: Rhône
city: Lyon
country: France
facility: Site FR33030
state: Rhône
city: Chalon-Sus-Saone
country: France
facility: Site FR33058
state: Saône-et-Loire
city: Amiens
country: France
facility: Site FR33008
state: Somme
city: Amiens
country: France
facility: Site FR33032
state: Somme
city: Créteil
country: France
facility: Site FR33014
state: Val-de-Marne
city: Saint Mandé
country: France
facility: Site FR33037
state: Val-de-Marne
city: Toulon
country: France
facility: Site FR33011
state: Var
city: Avignon Cedex 9
country: France
facility: Site FR33001
state: Vaucluse
city: Arras
country: France
facility: Site FR33046
city: Hyères
country: France
facility: Site FR33054
city: La Chaussée-Saint-Victor
country: France
facility: Site FR33038
city: Paris
country: France
facility: Site FR33057
city: Paris
country: France
facility: Site FR33034
city: Paris
country: France
facility: Site FR33029
city: Paris
country: France
facility: Site FR33064
city: Nürtingen
country: Germany
facility: Site DE49001
state: Baden-Württemberg
city: Wiesbaden
country: Germany
facility: Site DE49016
state: Hessen
city: Lüneburg
country: Germany
facility: Site DE49003
state: Niedersachsen
city: Soltau
country: Germany
facility: Site DE49011
state: Niedersachsen
city: Bonn
country: Germany
facility: Site DE49013
state: Nordrhein-Westfalen
city: Bernburg
country: Germany
facility: Site DE49009
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: Site DE49012
state: Sachsen
city: Kiel
country: Germany
facility: Site DE49015
state: Schleswig-Holstein
city: Köln
country: Germany
facility: Site DE49005
city: Rostock
country: Germany
facility: Site DE49006
city: Wuppertal
country: Germany
facility: Site DE49014
city: Würselen
country: Germany
facility: Site DE49010
city: Kifisia
country: Greece
facility: Site GC30001
state: Attiki
city: Athens
country: Greece
facility: Site GC30013
city: Athens
country: Greece
facility: Site GC30007
city: Athens
country: Greece
facility: Site GC30005
city: Athens
country: Greece
facility: Site GC30010
city: Athens
country: Greece
facility: Site GC30003
city: Ioannina
country: Greece
facility: Site GC30004
city: Ioannina
country: Greece
facility: Site GC30006
city: Larissa
country: Greece
facility: Site GC30012
city: Thessaloniki
country: Greece
facility: Site GC30008
city: Thessaloniki
country: Greece
facility: Site GC30002
city: Thessaloniki
country: Greece
facility: Site GC30011
city: Debrecen
country: Hungary
facility: Site HU36006
state: Hajdú-Bihar
city: Budapest
country: Hungary
facility: Site HU36002
city: Budapest
country: Hungary
facility: Site HU36001
city: Szeged
country: Hungary
facility: Site HU36005
city: Szombathely
country: Hungary
facility: Site HU36003
city: Dublin
country: Ireland
facility: Site IR35304
city: Dublin
country: Ireland
facility: Site IR35302
city: Dublin
country: Ireland
facility: Site IR35305
city: Dublin
country: Ireland
facility: Site IR35306
city: Meldola
country: Italy
facility: Site IT39001
state: Forlì
city: Lecco
country: Italy
facility: Site IT39010
state: Lombardia
city: Rozzano
country: Italy
facility: Site IT39009
state: Milano
city: Aviano
country: Italy
facility: Site IT39002
state: Pordenone
city: Candiolo
country: Italy
facility: Site IT39013
state: Torino
city: Mirano
country: Italy
facility: Site IT39011
state: Venezia
city: Bari
country: Italy
facility: Site IT39005
city: Catania
country: Italy
facility: Site IT39012
city: Firenze
country: Italy
facility: Site IT39006
city: Milano
country: Italy
facility: Site IT39004
city: Milano
country: Italy
facility: Site IT39017
city: Modena
country: Italy
facility: Site IT39003
city: Napoli
country: Italy
facility: Site IT39007
city: Novara
country: Italy
facility: Site IT39018
city: Padova
country: Italy
facility: Site IT39008
city: Palermo
country: Italy
facility: Site IT39015
city: Pisa
country: Italy
facility: Site IT39014
city: Reggio Emilia
country: Italy
facility: Site IT39016
city: Arnhem
country: Netherlands
facility: Site NL31006
city: Breda
country: Netherlands
facility: Site NL31007
city: Den Haag
country: Netherlands
facility: Site NL31003
city: Doetinchem
country: Netherlands
facility: Site NL31005
city: Helmond
country: Netherlands
facility: Site NL31008
city: Hilversum
country: Netherlands
facility: Site NL31001
city: Hoofddorp
country: Netherlands
facility: Site NL31004
city: Nieuwegein
country: Netherlands
facility: Site NL31010
city: Zwolle
country: Netherlands
facility: Site NL31011
city: Porto
country: Portugal
facility: Site PT35101
city: Ljubljana
country: Slovenia
facility: Site SV38501
city: Zaragoza
country: Spain
facility: Site ES34007
state: Aragón
city: Zaragoza
country: Spain
facility: Site ES34012
state: Aragón
city: Guadalajara
country: Spain
facility: Site ES34008
state: Castilla La Mancha
city: Toledo
country: Spain
facility: Site ES34009
state: Castilla La Mancha
city: Barcelona
country: Spain
facility: Site ES34013
state: Cataluña
city: Lleida
country: Spain
facility: Site ES34011
state: Cataluña
city: Reus
country: Spain
facility: Site ES34010
state: Cataluña
city: Badajoz
country: Spain
facility: Site ES34004
state: Extremadura
city: Cáceres
country: Spain
facility: Site ES34006
state: Extremadura
city: A Coruña
country: Spain
facility: Site ES34005
state: Galicia
city: Lugo
country: Spain
facility: Site ES34016
state: Galicia
city: Orense
country: Spain
facility: Site ES34003
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Site ES34001
state: Galicia
city: Vigo
country: Spain
facility: Site ES34017
state: Galicia
city: Aberdeen
country: United Kingdom
facility: Site GB44001
state: Aberdeenshire
city: Torquay
country: United Kingdom
facility: Site GB44012
state: Devon
city: Poole
country: United Kingdom
facility: Site GB44025
state: Dorset
city: Blackburn
country: United Kingdom
facility: Site GB44026
state: Lancashire
city: Preston
country: United Kingdom
facility: Site GB44011
state: Lancashire
city: Boston
country: United Kingdom
facility: Site GB44004
state: Lincolnshire
city: Lincoln
country: United Kingdom
facility: Site GB44002
state: Lincolnshire
city: Berkshire
country: United Kingdom
facility: Site GB44008
state: Slough
city: Weston-super-Mare
country: United Kingdom
facility: Site GB44013
state: Somerset
city: Treliske
country: United Kingdom
facility: Site GB44007
state: Truro
city: Swindon
country: United Kingdom
facility: Site GB44009
state: Wiltshire
city: Worcester
country: United Kingdom
facility: Site GB44005
state: Worcestershire
city: Birmingham
country: United Kingdom
facility: Site GB44023
city: Brighton
country: United Kingdom
facility: Site GB44010
city: Derby
country: United Kingdom
facility: Site GB44016
city: Guildford
country: United Kingdom
facility: Site GB44020
city: Inverness-shire
country: United Kingdom
facility: Site GB44022
city: Leicester
country: United Kingdom
facility: Site GB44024
city: London
country: United Kingdom
facility: Site GB44003
city: Newcastle upon Tyne
country: United Kingdom
facility: Site GB44017
city: Norfolk
country: United Kingdom
facility: Site GB44015
city: Reading
country: United Kingdom
facility: Site GB44006
city: Taunton
country: United Kingdom
facility: Site GB44014
city: Wolverhampton
country: United Kingdom
facility: Site GB44018
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Clinical Research Physician
role: STUDY_DIRECTOR
References: