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| Name | Class |
|---|---|
| Medivation, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with mCRPC prescribed enzalutamide | Oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enzalutamide | Drug | oral |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients with the following will be excluded from study participation in France only:
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Patients with metastatic castration resistant prostate cancer prescribed enzalutamide as part of standard clinical practice
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Research Physician | Astellas Pharma Europe Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site AT43001 | Bregenz | 6900 | Austria | |||
| Site AT43005 |
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/.
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| 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 |
| 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 | Naples | 80131 | Italy |
| Site IT39018 | Novara | 28100 | Italy |
| Site IT39008 | Padova | 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 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
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