Study Details

A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone

Recruitment complete
The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT02288247

Astellas Study ID

The unique identification code given by the study sponsor.

9785-MA-1001

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2013-004711-50

Condition

Prostate Cancer

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

18 Years - N/A

Sex

Male

Product

enzalutamide

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Dec 2014 - Oct 2023

Masking

Triple (Participant, Investigator, Outcomes Assessor)

Enrollment number

688

A Randomized, Double Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide in Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer Patients Treated with Docetaxel Plus Prednisolone Who Have Progressed on Enzalutamide Alone

Study summary

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Locations

Site NO47004

Stavanger, Norway, 4011

Site SE46004

Uppsala, Sweden, 751 85

Site BE32005

Turnhout, Belgium, 2300

Site ES34007

Malaga, Spain, 29010

Site RU70003

Moscow, Russian Federation, 125284

Site RU70001

Moscow, Russian Federation, 115478

Site GB44002

Nottingham, United Kingdom, NG5 1PB

Site GB44004

Cambridge, United Kingdom, CB2 0QQ

Site TR90003

Istanbul, Turkey, 34722

Site ES34006

Valencia, Spain, 46009

Site DE49004

Wuppertal, Germany, 42103

Site GR30004

Heraklion, Greece, 71403

Site DE49002

Munster, Germany, 48149

Site FR33012

Albi, France, 81000

Site PL48002

Lodz, Poland, 93-513

Site ES34003

Madrid, Spain, 28007

Site FR33005

Suresnes, France, 92151

Site RU70002

Moscow, Russian Federation, 105077

Site PL48005

Warszawa, Poland, 04-141

Site BE32008

Wilrijk, Belgium, 2610

Site DE49017

Ulm, Germany, 89075

Site GB44018

Cardiff, United Kingdom, CF4 7XL

Site ES34008

Santander, Spain, 39008

Site ES34001

Madrid, Spain, 28040

Site FR33004

Plerin, France, 22190

Site DE49008

Aachen, Germany, 52074

Site DE49001

Hannover, Germany, 30625

Site PL48004

Gdańsk, Poland, 80-952

Site GB44014

Exeter, United Kingdom

Site AT43001

Vienna, Austria, 1090

Site ES34010

Madrid, Spain

Site PL48006

Warszawa, Poland, 02-507

Site IT39008

Naples, Italy, 80131

Site IT39010

Pavia, Italy, 27100

Site NO47005

Drammen, Norway, 3004

Site GB44020

Northwood, United Kingdom, HA62RN

Site RU70004

Obninsk, Russian Federation, 24903

Site SE46005

Kalmar, Sweden, 39185

Site FR33011

Reims, France, 51056

Site GB44007

Wirral, United Kingdom, CH63 4JY

Site GR30006

Athens, Greece, 155 62

Site PL48003

Krakow, Poland, 31-501

Site FR33002

Nîmes, France, 30907 cedex 2

Site TR90001

Ankara, Turkey, 06500

Site DE49015

Tübingen, Germany, 72076

Site GB44003

London, United Kingdom, SE1 9RT

Site NL31010

Nieuwegein, Netherlands, 3435 CM

Site IT39002

Terni, Italy, 05100

Site FR33008

Paris, France, 75014

Site DE49018

Nürtingen, Germany, 72622

Site ES34005

Lugo, Spain, 27003

Site IT39003

Milano, Italy, 20100

Site CH41005

Locarno, Switzerland, 6600

Site IT39004

Rome, Italy, 161

Site RU70005

St. Petersburg, Russian Federation, 197022

Site NO47001

Kristiansand, Norway, 4615

Site CZ42004

Brno, Czech Republic, 656 91

Site IT39001

Arezzo, Italy, 52100

Site FR33006

Vandoeuvre les Nancy, France, 54511

Site NL31002

Amsterdam, Netherlands, 1066 CX

Site GB44015

Norwich, United Kingdom, NR4 7UY

Site TR90002

Izmir, Turkey, 35340

Site CH41009

Zurich, Switzerland, CH-8038

Site CZ42003

Olomouc, Czech Republic, 77520

Site NL31003

Rotterdam, Netherlands, 3045 PM

Site GR30001

Heraklion, Greece, 70013

Site IT39013

Rome, Italy, 00152

Site ES34009

Murcia, Spain, 30008

Site GB44010

Aberdeen, United Kingdom, AB25 2ZN

Site BE32004

Ottignies, Belgium, 1340

Site CZ42001

Praha 2, Czech Republic, 12808

Site GB44017

Swansea, United Kingdom, SA2 8QA

Site ES34002

Madrid, Spain, 28041

Site FR33013

Quimper, France, 29000

Site DE49006

Heidelberg, Germany, 69120

Site BE32002

Liege, Belgium, 4000

Site FR33003

Montpellier, France, 34298 cedex 5

Site DE49010

Bergisch Gladbach, Germany, 51465

Site SE46003

Solna, Sweden, 171 76

Site SE46002

Göteborg, Sweden, 413 45

Site ES34004

Sevilla, Spain, 41013

Site RU70006

St. Petersburg, Russian Federation, 197758

Site BE32003

Bonheiden, Belgium, 2820

Site CZ42002

Plzeň -Lochotín, Czech Republic, 30460

Site DE49003

Mannheim, Germany, 68167

Site FR33014

Paris, France, 75014

Site NL31007

Blaricum, Netherlands, 1261 AN

Site IT39012

Brescia, Italy, 25126

Site AT43004

Linz, Austria, 4010

Site GR30003

Athens, Greece, 14564

Site NL31004

Hoofddorp, Netherlands, 2134 TM

Site GR30005

Thessaloniki, Greece, 54007

Site IT39005

Roma, Italy, 00128

Site GR30002

Larissa, Greece, 41110