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)

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 Overview

• Status: Completed
• Conditions: Metastatic Castration Resistant Prostate Cancer
• Intervention / Treatment: Drug: enzalutamide

• Study Type: Observational
• Enrollment (Actual): 1763

Contacts and Locations

Study Locations

• Austria
  • Bregenz, Austria, 6900
    • Site AT43001
  • Innsbruck, Austria, 6020
    • Site AT43005
  • Linz, Austria, 4010
    • Site AT43006
  • Wien, Austria, 1090
    • Site AT43004
• Belgium
  • Brussels, Belgium, 1070
    • Site BL32001
  • Bruxelles, Belgium, 1200
    • Site BL32011
  • Hasselt, Belgium, 3500
    • Site BL32012
  • Antwerpen
    • Bonheiden, Antwerpen, Belgium, 2820
      • Site BL32003
    • Brasschaat, Antwerpen, Belgium, 2930
      • Site BL32004
  • Hainaut
    • Haine-Saint-Paul, Hainaut, Belgium, 7100
      • Site BL32007
  • Oost-Vlaanderen
    • Aalst, Oost-Vlaanderen, Belgium, 9300
      • Site BL32008
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Site BL32009
    • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
      • Site BL32010
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Site BL32013
  • West-Vlaanderen
    • Kortrijk, West-Vlaanderen, Belgium, 8500
      • Site BL32005
• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • Site BG35903
  • Sofia, Bulgaria, 1303
    • Site BG35901
• Czechia
  • Brno, Czechia, 656 91
    • Site CZ42004
  • Jihlava, Czechia, 586 33
    • Site CZ42007
  • Novy Jicin, Czechia, 741 01
    • Site CZ42003
  • Praha, Czechia, 140 59
    • Site CZ42001
  • Praha, Czechia, 180 81
    • Site CZ42006
• Denmark
  • Aalborg, Denmark, 9100
    • Site DK45003
  • Aarhus, Denmark, 8000
    • Site DK45004
  • Copenhagen, Denmark, 2200
    • Site DK45002
  • Herlev, Denmark, 2730
    • Site DK45001
• France
  • Arras, France, 62660
    • Site FR33046
  • Hyères, France, 83400
    • Site FR33054
  • La Chaussée-Saint-Victor, France, 41260
    • Site FR33038
  • Paris, France, 75014
    • Site FR33057
  • Paris, France, 75020
    • Site FR33034
  • Paris, France, 75475
    • Site FR33029
  • Paris, France, 75908
    • Site FR33064
  • Alsace
    • Colmar, Alsace, France, 68024
      • Site FR33015
    • Strasbourg, Alsace, France, 67000
      • Site FR33003
  • Aquitaine
    • Bordeaux, Aquitaine, France, 33000
      • Site FR33017
    • Bordeaux, Aquitaine, France, 33000
      • Site FR33051
    • Bordeaux, Aquitaine, France, 33300
      • Site FR33018
  • Auvergne
    • Clermont Ferrand, Auvergne, France, 63100
      • Site FR33022
  • Bouches-du-Rhône
    • Aix en Provence, Bouches-du-Rhône, France, 13617
      • Site FR33006
    • Marseille, Bouches-du-Rhône, France, 13005
      • Site FR33027
    • Marseille, Bouches-du-Rhône, France, 13286
      • Site FR33041
  • Boulogne-sur-Mer
    • Saint-Martin-Boulogne, Boulogne-sur-Mer, France, 62222
      • Site FR33069
  • Bourgogne
    • Sens, Bourgogne, France, 89100
      • Site FR33043
  • Bretagne
    • Brest Cedex 2, Bretagne, France, 29229
      • Site FR33026
    • Saint Grégoire, Bretagne, France, 35760
      • Site FR33004
    • Vannes, Bretagne, France, 56000
      • Site FR33025
  • Champagne-Ardenne
    • Reims Cedex, Champagne-Ardenne, France, 51726
      • Site FR33010
  • Côte-d'Or
    • Dijon, Côte-d'Or, France, 21000
      • Site FR33067
  • Essonne
    • Longjumeau, Essonne, France, 91164
      • Site FR33062
  • Eure
    • Evreux, Eure, France, 27000
      • Site FR33033
  • Finistère
    • Quimper, Finistère, France, 29000
      • Site FR33002
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • Site FR33040
  • Hautes-Alpes
    • Gap, Hautes-Alpes, France, 05000
      • Site FR33049
  • Hauts-de-Seine
    • Suresnes, Hauts-de-Seine, France, 92151
      • Site FR33042
  • Indre-et-Loire
    • Tours, Indre-et-Loire, France, 37044
      • Site FR33020
  • Isère
    • Grenoble, Isère, France, 38043
      • Site FR33060
  • Languedoc-Roussillon
    • Bézier, Languedoc-Roussillon, France, 34500
      • Site FR33050
  • Loire
    • Saint-Priest-en-Jarez, Loire, France, 42271
      • Site FR33016
  • Loiret
    • Orléans, Loiret, France, 45067
      • Site FR33066
  • Lorraine
    • Vandœuvre-lès-Nancy, Lorraine, France, 54519
      • Site FR33061
  • Lot-et-Garonne
    • Agen, Lot-et-Garonne, France, 47000
      • Site FR33065
  • Maine-et-Loire
    • Angers, Maine-et-Loire, France, 49933
      • Site FR33019
  • Meurthe-et-Moselle
    • Nancy, Meurthe-et-Moselle, France, 54000
      • Site FR33007
  • Midi-Pyrénées
    • Albi, Midi-Pyrénées, France, 81000
      • Site FR33059
  • Nord
    • Coudekerque-Branche Cedex, Nord, France, 59210
      • Site FR33021
  • Nord-Pas-de-Calais
    • Lille, Nord-Pas-de-Calais, France, 59037
      • Site FR33039
  • Oise
    • Beauvais, Oise, France, 60000
      • Site FR33063
  • Picardie
    • Amiens, Picardie, France, 80094
      • Site FR33070
    • Saint Quentin Cedex, Picardie, France, 02321
      • Site FR33044
  • Puy-de-Dôme
    • Clermont Ferrand Cedex 1, Puy-de-Dôme, France, 63003
      • Site FR33028
  • Pyrénées-Atlantiques
    • Bayonne, Pyrénées-Atlantiques, France, 64100
      • Site FR33035
  • Rhône
    • Lyon, Rhône, France, 69437
      • Site FR33030
    • Lyon Cedex 9, Rhône, France, 69009
      • Site FR33012
  • Rhône-Alpes
    • Valence, Rhône-Alpes, France, 26000
      • Site FR33009
  • Saône-et-Loire
    • Chalon-Sus-Saone, Saône-et-Loire, France, 71100
      • Site FR33058
  • Somme
    • Amiens, Somme, France, 80000
      • Site FR33008
    • Amiens, Somme, France, 80090
      • Site FR33032
  • Val-de-Marne
    • Créteil, Val-de-Marne, France, 94400
      • Site FR33014
    • Saint Mandé, Val-de-Marne, France, 94160
      • Site FR33037
  • Var
    • Toulon, Var, France, 83100
      • Site FR33011
  • Vaucluse
    • Avignon Cedex 9, Vaucluse, France, 84918
      • Site FR33001
• Germany
  • Köln, Germany, 50968
    • Site DE49005
  • Rostock, Germany, 18107
    • Site DE49006
  • Wuppertal, Germany, 42103
    • Site DE49014
  • Würselen, Germany, 52146
    • Site DE49010
  • Baden-Württemberg
    • Nürtingen, Baden-Württemberg, Germany, 72622
      • Site DE49001
  • Hessen
    • Wiesbaden, Hessen, Germany, 65191
      • Site DE49016
  • Niedersachsen
    • Lüneburg, Niedersachsen, Germany, 21335
      • Site DE49003
    • Soltau, Niedersachsen, Germany, 29614
      • Site DE49011
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53111
      • Site DE49013
  • Sachsen
    • Chemnitz, Sachsen, Germany, 09130
      • Site DE49012
  • Sachsen-Anhalt
    • Bernburg, Sachsen-Anhalt, Germany, 06406
      • Site DE49009
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24103
      • Site DE49015
• Greece
  • Athens, Greece, 11528
    • Site GC30013
  • Athens, Greece, 45001
    • Site GC30007
  • Athens, Greece, 45500
    • Site GC30005
  • Athens, Greece, 54642
    • Site GC30010
  • Athens, Greece, 57001
    • Site GC30003
  • Ioannina, Greece, 11525
    • Site GC30004
  • Ioannina, Greece, 15126
    • Site GC30006
  • Larissa, Greece, 41110
    • Site GC30012
  • Thessaloniki, Greece, 11522
    • Site GC30008
  • Thessaloniki, Greece, 14564
    • Site GC30002
  • Thessaloniki, Greece, 56403
    • Site GC30011
  • Attiki
    • Kifisia, Attiki, Greece, 14564
      • Site GC30001
• Hungary
  • Budapest, Hungary, 1082
    • Site HU36002
  • Budapest, Hungary, 1122
    • Site HU36001
  • Szeged, Hungary, H-6720
    • Site HU36005
  • Szombathely, Hungary, H-9700
    • Site HU36003
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Site HU36006
• Ireland
  • Dublin, Ireland, 24
    • Site IR35304
  • Dublin, Ireland, 7
    • Site IR35302
  • Dublin, Ireland, 7
    • Site IR35305
  • Dublin, Ireland, 8
    • Site IR35306
• Italy
  • Bari, Italy, 70124
    • Site IT39005
  • Catania, Italy, 95122
    • Site IT39012
  • Firenze, Italy, 50134
    • Site IT39006
  • Milano, Italy, 20141
    • Site IT39004
  • Milano, Italy, 20162
    • Site IT39017
  • Modena, Italy, 41124
    • Site IT39003
  • Napoli, Italy, 80131
    • Site IT39007
  • Novara, Italy, 28100
    • Site IT39018
  • Padova, Italy, 35128
    • Site IT39008
  • Palermo, Italy, 90146
    • Site IT39015
  • Pisa, Italy, 56126
    • Site IT39014
  • Reggio Emilia, Italy, 42100
    • Site IT39016
  • Forlì
    • Meldola, Forlì, Italy, 47014
      • Site IT39001
  • Lombardia
    • Lecco, Lombardia, Italy, 23900
      • Site IT39010
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Site IT39009
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Site IT39002
  • Torino
    • Candiolo, Torino, Italy, 10060
      • Site IT39013
  • Venezia
    • Mirano, Venezia, Italy, 30035
      • Site IT39011
• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • Site NL31006
  • Breda, Netherlands, 4819 EV
    • Site NL31007
  • Den Haag, Netherlands, 2545 CH
    • Site NL31003
  • Doetinchem, Netherlands, 7009 BL
    • Site NL31005
  • Helmond, Netherlands, 5707 HA
    • Site NL31008
  • Hilversum, Netherlands, 1213 XZ
    • Site NL31001
  • Hoofddorp, Netherlands, 2134 TM
    • Site NL31004
  • Nieuwegein, Netherlands, 3435 CM
    • Site NL31010
  • Zwolle, Netherlands, 8025 AB
    • Site NL31011
• Portugal
  • Porto, Portugal, 4099-001
    • Site PT35101
• Slovenia
  • Ljubljana, Slovenia
    • Site SV38501
• Spain
  • Aragón
    • Zaragoza, Aragón, Spain, 50009
      • Site ES34007
    • Zaragoza, Aragón, Spain, 50009
      • Site ES34012
  • Castilla La Mancha
    • Guadalajara, Castilla La Mancha, Spain, 19002
      • Site ES34008
    • Toledo, Castilla La Mancha, Spain, 45004
      • Site ES34009
  • Cataluña
    • Barcelona, Cataluña, Spain, 08036
      • Site ES34013
    • Lleida, Cataluña, Spain, 25198
      • Site ES34011
    • Reus, Cataluña, Spain, 43204
      • Site ES34010
  • Extremadura
    • Badajoz, Extremadura, Spain, 06002
      • Site ES34004
    • Cáceres, Extremadura, Spain, 10003
      • Site ES34006
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Site ES34005
    • Lugo, Galicia, Spain, 27003
      • Site ES34016
    • Orense, Galicia, Spain, 32005
      • Site ES34003
    • Santiago de Compostela, Galicia, Spain, 15706
      • Site ES34001
    • Vigo, Galicia, Spain, 36312
      • Site ES34017
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Site GB44023
  • Brighton, United Kingdom, BN2 3EW
    • Site GB44010
  • Derby, United Kingdom, DE22 3NE
    • Site GB44016
  • Guildford, United Kingdom, GU2 7XX
    • Site GB44020
  • Inverness-shire, United Kingdom, IV2 3UJ
    • Site GB44022
  • Leicester, United Kingdom, LE1 5WW
    • Site GB44024
  • London, United Kingdom, NW1 2BU
    • Site GB44003
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Site GB44017
  • Norfolk, United Kingdom, PE30 4ET
    • Site GB44015
  • Reading, United Kingdom, RG1 5AN
    • Site GB44006
  • Taunton, United Kingdom, TA1 5DA
    • Site GB44014
  • Wolverhampton, United Kingdom, WV10 0QP
    • Site GB44018
  • Aberdeenshire
    • Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
      • Site GB44001
  • Devon
    • Torquay, Devon, United Kingdom, TQ2 7AA
      • Site GB44012
  • Dorset
    • Poole, Dorset, United Kingdom, BH15 2JB
      • Site GB44025
  • Lancashire
    • Blackburn, Lancashire, United Kingdom, BB2 3HH
      • Site GB44026
    • Preston, Lancashire, United Kingdom, PR2 9HT
      • Site GB44011
  • Lincolnshire
    • Boston, Lincolnshire, United Kingdom, PE21 9QS
      • Site GB44004
    • Lincoln, Lincolnshire, United Kingdom, LN2 5QY
      • Site GB44002
  • Slough
    • Berkshire, Slough, United Kingdom, SL2 4HL
      • Site GB44008
  • Somerset
    • Weston-super-Mare, Somerset, United Kingdom, BS23 4TQ
      • Site GB44013
  • Truro
    • Treliske, Truro, United Kingdom, TR1 3LJ
      • Site GB44007
  • Wiltshire
    • Swindon, Wiltshire, United Kingdom, SN3 6BB
      • Site GB44009
  • Worcestershire
    • Worcester, Worcestershire, United Kingdom, WR5 1DD
      • Site GB44005

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic castration resistant prostate cancer prescribed enzalutamide as part of standard clinical practice

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with mCRPC prescribed enzalutamide; Oral	Drug: enzalutamide; oral; Other Names: Xtandi

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Astellas Pharma Europe Ltd.
• Collaborators: Medivation, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2015
• Primary Completion (Actual): February 8, 2019
• Study Completion (Actual): February 8, 2019

Study Registration Dates

• First Submitted: July 9, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 13, 2015

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Prostate cancer; Xtandi; Enzalutamide; Metastatic castration resistant prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 9785-MA-1002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."