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Metastatic Castration Resistant Prostate CancerPREMISENCT02495974

European Observational Study of Enzalutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

An observational study of Metastatic Castration Resistant Prostate Cancer, run by Astellas Pharma Europe Ltd. at 182 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Any age, men only
What is being tested?
enzalutamide
Type of treatment
Pill or oral medicine
How many people
1,763 participants
Where
182 sitesin 16 countries
Study dates
8 Sep 2015to 8 Feb 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

182 sites in 16 countries.

182 sites in 16 countries

France56 sites

  • Site FR33065

    Agen, Lot-et-Garonne, 47000

  • Site FR33006

    Aix-en-Provence, Bouches-du-Rhône, 13617

  • Site FR33059

    Albi, Midi-Pyrénées, 81000

  • Site FR33070

    Amiens, Picardie, 80094

  • Site FR33008

    Amiens, Somme, 80000

  • Site FR33032

    Amiens, Somme, 80090

  • Site FR33019

    Angers, Maine-et-Loire, 49933

  • Site FR33046

    Arras, 62660

  • Site FR33001

    Avignon, Vaucluse, 84918

  • Site FR33035

    Bayonne, Pyrénées-Atlantiques, 64100

  • Site FR33063

    Beauvais, Oise, 60000

  • Site FR33050

    Bézier, Languedoc-Roussillon, 34500

  • Site FR33017

    Bordeaux, Aquitaine, 33000

  • Site FR33051

    Bordeaux, Aquitaine, 33000

  • Site FR33018

    Bordeaux, Aquitaine, 33300

  • Site FR33026

    Brest, Brittany Region, 29229

  • Site FR33058

    Chalon-Sus-Saone, Saône-et-Loire, 71100

  • Site FR33022

    Clermont-Ferrand, Auvergne, 63100

  • Site FR33028

    Clermont-Ferrand, Puy-de-Dôme, 63003

  • Site FR33015

    Colmar, Alsace, 68024

  • Site FR33021

    Coudekerque-Branche, Nord, 59210

  • Site FR33014

    Créteil, Val-de-Marne, 94400

  • Site FR33067

    Dijon, Côte-d'Or, 21000

  • Site FR33033

    Évreux, Eure, 27000

  • Site FR33049

    Gap, Hautes-Alpes, 05000

  • Site FR33060

    Grenoble, Isère, 38043

  • Site FR33054

    Hyères, 83400

  • Site FR33038

    La Chaussée-Saint-Victor, 41260

  • Site FR33039

    Lille, Hauts-de-France, 59037

  • Site FR33062

    Longjumeau, Essonne, 91164

  • Site FR33012

    Lyon, Rhône, 69009

  • Site FR33030

    Lyon, Rhône, 69437

  • Site FR33027

    Marseille, Bouches-du-Rhône, 13005

  • Site FR33041

    Marseille, Bouches-du-Rhône, 13286

  • Site FR33007

    Nancy, Meurthe-et-Moselle, 54000

  • Site FR33066

    Orléans, Loiret, 45067

  • Site FR33057

    Paris, 75014

  • Site FR33034

    Paris, 75020

  • Site FR33029

    Paris, 75475

  • Site FR33064

    Paris, 75908

  • Site FR33002

    Quimper, Finistère, 29000

  • Site FR33010

    Reims, Champagne-Ardenne, 51726

  • Site FR33004

    Saint-Grégoire, Brittany Region, 35760

  • Site FR33037

    Saint-Mandé, Val-de-Marne, 94160

  • Site FR33069

    Saint-Martin-Boulogne, Boulogne-sur-Mer, 62222

  • Site FR33016

    Saint-Priest-en-Jarez, Pays de la Loire Region, 42271

  • Site FR33044

    Saint-Quentin, Picardie, 02321

  • Site FR33043

    Sens, Bourgogne-Franche-Comté, 89100

  • Site FR33003

    Strasbourg, Alsace, 67000

  • Site FR33042

    Suresnes, Hauts-de-Seine, 92151

  • Site FR33011

    Toulon, Var, 83100

  • Site FR33040

    Toulouse, Haute-Garonne, 31059

  • Site FR33020

    Tours, Indre-et-Loire, 37044

  • Site FR33009

    Valence, Auvergne-Rhône-Alpes, 26000

  • Site FR33061

    Vandœuvre-lès-Nancy, Lorraine, 54519

  • Site FR33025

    Vannes, Brittany Region, 56000

Other trials in France

United Kingdom24 sites

  • Site GB44001

    Aberdeen, Aberdeenshire, AB25 2ZN

  • Site GB44008

    Berkshire, Slough, SL2 4HL

  • Site GB44023

    Birmingham, B15 2TH

  • Site GB44026

    Blackburn, Lancashire, BB2 3HH

  • Site GB44004

    Boston, Lincolnshire, PE21 9QS

  • Site GB44010

    Brighton, BN2 3EW

  • Site GB44016

    Derby, DE22 3NE

  • Site GB44020

    Guildford, GU2 7XX

  • Site GB44022

    Inverness-shire, IV2 3UJ

  • Site GB44024

    Leicester, LE1 5WW

  • Site GB44002

    Lincoln, Lincolnshire, LN2 5QY

  • Site GB44003

    London, NW1 2BU

  • Site GB44017

    Newcastle upon Tyne, NE7 7DN

  • Site GB44015

    Norfolk, PE30 4ET

  • Site GB44025

    Poole, Dorset, BH15 2JB

  • Site GB44011

    Preston, Lancashire, PR2 9HT

  • Site GB44006

    Reading, RG1 5AN

  • Site GB44009

    Swindon, Wiltshire, SN3 6BB

  • Site GB44014

    Taunton, TA1 5DA

  • Site GB44012

    Torquay, Devon, TQ2 7AA

  • Site GB44007

    Treliske, Truro, TR1 3LJ

  • Site GB44013

    Weston-super-Mare, Somerset, BS23 4TQ

  • Site GB44018

    Wolverhampton, WV10 0QP

  • Site GB44005

    Worcester, Worcestershire, WR5 1DD

Other trials in United Kingdom

Italy18 sites

  • Site IT39002

    Aviano, Pordenone, 33081

  • Site IT39005

    Bari, 70124

  • Site IT39013

    Candiolo, Torino, 10060

  • Site IT39012

    Catania, 95122

  • Site IT39006

    Florence, 50134

  • Site IT39010

    Lecco, Lombardy, 23900

  • Site IT39001

    Meldola, Forlì, 47014

  • Site IT39004

    Milan, 20141

  • Site IT39017

    Milan, 20162

  • Site IT39011

    Mirano, Venezia, 30035

  • Site IT39003

    Modena, 41124

  • Site IT39007

    Naples, 80131

  • Site IT39018

    Novara, 28100

  • Site IT39008

    Padova, 35128

  • Site IT39015

    Palermo, 90146

  • Site IT39014

    Pisa, 56126

  • Site IT39016

    Reggio Emilia, 42100

  • Site IT39009

    Rozzano, Milano, 20089

Other trials in Italy

Spain14 sites

  • Site ES34005

    A Coruña, Galicia, 15006

  • Site ES34004

    Badajoz, Extremadura, 06002

  • Site ES34013

    Barcelona, Catalonia, 08036

  • Site ES34006

    Cáceres, Extremadura, 10003

  • Site ES34008

    Guadalajara, Castille-La Mancha, 19002

  • Site ES34011

    Lleida, Catalonia, 25198

  • Site ES34016

    Lugo, Galicia, 27003

  • Site ES34003

    Ourense, Galicia, 32005

  • Site ES34010

    Reus, Catalonia, 43204

  • Site ES34001

    Santiago de Compostela, Galicia, 15706

  • Site ES34009

    Toledo, Castille-La Mancha, 45004

  • Site ES34017

    Vigo, Galicia, 36312

  • Site ES34007

    Zaragoza, Aragon, 50009

  • Site ES34012

    Zaragoza, Aragon, 50009

Other trials in Spain

Germany12 sites

  • Site DE49009

    Bernburg, Saxony-Anhalt, 06406

  • Site DE49013

    Bonn, North Rhine-Westphalia, 53111

  • Site DE49012

    Chemnitz, Saxony, 09130

  • Site DE49005

    Cologne, 50968

  • Site DE49015

    Kiel, Schleswig-Holstein, 24103

  • Site DE49003

    Lüneburg, Lower Saxony, 21335

  • Site DE49001

    Nürtingen, Baden-Wurttemberg, 72622

  • Site DE49006

    Rostock, 18107

  • Site DE49011

    Soltau, Lower Saxony, 29614

  • Site DE49016

    Wiesbaden, Hesse, 65191

  • Site DE49014

    Wuppertal, 42103

  • Site DE49010

    Würselen, 52146

Other trials in Germany

Greece12 sites

  • Site GC30013

    Athens, 11528

  • Site GC30007

    Athens, 45001

  • Site GC30005

    Athens, 45500

  • Site GC30010

    Athens, 54642

  • Site GC30003

    Athens, 57001

  • Site GC30004

    Ioannina, 11525

  • Site GC30006

    Ioannina, 15126

  • Site GC30001

    Kifissia, Attica, 14564

  • Site GC30012

    Larissa, 41110

  • Site GC30008

    Thessaloniki, 11522

  • Site GC30002

    Thessaloniki, 14564

  • Site GC30011

    Thessaloniki, 56403

Other trials in Greece

Belgium11 sites

  • Site BL32008

    Aalst, Oost-Vlaanderen, 9300

  • Site BL32003

    Bonheiden, Antwerpen, 2820

  • Site BL32004

    Brasschaat, Antwerpen, 2930

  • Site BL32001

    Brussels, 1070

  • Site BL32011

    Brussels, 1200

  • Site BL32009

    Ghent, Oost-Vlaanderen, 9000

  • Site BL32007

    Haine-Saint-Paul, Hainaut, 7100

  • Site BL32012

    Hasselt, 3500

  • Site BL32005

    Kortrijk, West-Vlaanderen, 8500

  • Site BL32013

    Leuven, Vlaams Brabant, 3000

  • Site BL32010

    Sint-Niklaas, Oost-Vlaanderen, 9100

Other trials in Belgium

Netherlands9 sites

  • Site NL31006

    Arnhem, 6815 AD

  • Site NL31007

    Breda, 4819 EV

  • Site NL31005

    Doetinchem, 7009 BL

  • Site NL31008

    Helmond, 5707 HA

  • Site NL31001

    Hilversum, 1213 XZ

  • Site NL31004

    Hoofddorp, 2134 TM

  • Site NL31010

    Nieuwegein, 3435 CM

  • Site NL31003

    The Hague, 2545 CH

  • Site NL31011

    Zwolle, 8025 AB

Other trials in Netherlands

Czechia5 sites

  • Site CZ42004

    Brno, 656 91

  • Site CZ42007

    Jihlava, 586 33

  • Site CZ42003

    Nový Jičín, 741 01

  • Site CZ42001

    Prague, 140 59

  • Site CZ42006

    Prague, 180 81

Other trials in Czechia

Hungary5 sites

  • Site HU36002

    Budapest, 1082

  • Site HU36001

    Budapest, 1122

  • Site HU36006

    Debrecen, Hajdú-Bihar, 4032

  • Site HU36005

    Szeged, H-6720

  • Site HU36003

    Szombathely, H-9700

Other trials in Hungary

Austria4 sites

  • Site AT43001

    Bregenz, 6900

  • Site AT43005

    Innsbruck, 6020

  • Site AT43006

    Linz, 4010

  • Site AT43004

    Vienna, 1090

Other trials in Austria

Denmark4 sites

  • Site DK45003

    Aalborg, 9100

  • Site DK45004

    Aarhus, 8000

  • Site DK45002

    Copenhagen, 2200

  • Site DK45001

    Herlev, 2730

Other trials in Denmark

Ireland4 sites

  • Site IR35304

    Dublin, 24

  • Site IR35302

    Dublin, 7

  • Site IR35305

    Dublin, 7

  • Site IR35306

    Dublin, 8

Other trials in Ireland

Bulgaria2 sites

  • Site BG35903

    Plovdiv, 4000

  • Site BG35901

    Sofia, 1303

Other trials in Bulgaria

Portugal1 site

  • Site PT35101

    Porto, 4099-001

Other trials in Portugal

Slovenia1 site

  • Site SV38501

    Ljubljana

Other trials in Slovenia

About this study

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)

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.

Being tested
enzalutamide
Keywords
Xtandi, Enzalutamide, Prostate cancer, Metastatic castration resistant prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02495974
Study groupRoleWhat they receive
Patients with mCRPC prescribed enzalutamideOral
Receives: Drug: enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 18 months

Secondary outcomes (17)

  1. 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.

    Measured: up to 18 months

  2. PSA response

    Measured: up to 18 months

  3. 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.

    Measured: up to 18 months

  4. Overall Survival (France only)

    Time from initiation of enzalutamide to death or patient survival at the end of the study.

    Measured: up to 18 months

  5. Treatment duration

    Measured: up to 18 months

  6. Reason for initiation of treatment with enzalutamide

    Measured: up to 18 months

  7. Reason for enzalutamide discontinuation

    Measured: up to 18 months

  8. Subsequent anti-neoplastic therapy for mCRPC

    Measured: up to 18 months

  9. Time to opiate use

    Measured: up to 18 months

  10. 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.

    Measured: up to 18 months

  11. 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.

    Measured: up to 18 months

  12. 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.

    Measured: up to 18 months

  13. Number of participants hospitalized

    Measured: up to 18 months

  14. Number of visits to health care professionals

    Measured: up to 18 months

  15. Safety assessed by reported adverse events

    Measured: up to 18 months

  16. Safety assessed by modification of treatment with enzalutamide as a response to adverse events

    Measured: up to 18 months

  17. Number of Deaths

    Deaths defined as deaths due to any cause

    Measured: up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2015 (estimated)
  2. Study start8 Sep 2015
  3. Primary completion8 Feb 2019
  4. Study completion8 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,763 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02495974
Sponsor's protocol ID
9785-MA-1002
Acronym
PREMISE
Status last verified
Apr 2019
First submitted
9 Jul 2015
Last updated
21 Oct 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No: 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/.

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Castration Resistant Prostate Cancer, run by Astellas Pharma Europe Ltd. at 182 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 182 sites in France, United Kingdom, Italy, Spain, Germany and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to treatment failure (TTF) (time frame: up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02495974.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.

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