Study Details

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A Study of Enzalutamide versus Bicalutamide in Castrate Men with Metastatic Prostate Cancer

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01288911

Astellas Study ID

The unique identification code given by the study sponsor.

9785-CL-0222

EudraCT ID

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

2010-021868-15

Follow Trial

Condition

Prostate Cancer

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

Age

18 years - N/A

Sex

Male

Product

N/A

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

Mar 2011 - Nov 2017

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number

375

A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100 versus Bicalutamide in Castrate Men with Metastatic Prostate Cancer

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site FR3006

Saint Etienne Cedex 2, France, 42013

Site DK3356

Aarhus, Denmark, 8200

Site GB3245

Northwood, Middlesex, United Kingdom, HA6 2RN

Site US2945

Middlebury, United States, 06762

Site CA3084

Toronto, Canada, M5G 2M9

Site US2640

Los Angeles, United States, 90048

Site US3025

Poughkeepsie, United States, 12601

Site GB3028

Cardiff, United Kingdom, CF14 4XW

Site BE3289

Liege, Belgium

Site US1598

Bala Cynwyd, United States, 19004

Site US3197

Raleigh, United States, 27607

Site US2014

Melrose Park, United States, 60160

Site GB3030

London, United Kingdom, SW17 0QT

Site US1580

Burien, United States, 98166

Site GB3166

Glasgow, United Kingdom, G12 0YN

Site DE2989

Aachen, Germany, 51074

Site CA166

Toronto, Canada, M4N 3M5

Site GB2702

Cambridge, United Kingdom, CB2 0QQ

Site BE3015

Brussels, Belgium, 1090

Site DE2988

Wuppertal, Germany, 42103

Site US2185

Columbus, United States, 43221

Site US62

Kansas City, United States, 66160-7233

Site BE3017

Antwerp, Belgium, 2030

Site DE2993

Bonn, Germany, 53105

Site US44

Cincinnati, United States, 45267

Site DE3287

Bergisch Gladbach, Germany, D-51465

Site CA3242

Abbotsford, Canada, V2S 3N5

Site US892

Grand Rapids, United States, 49546

Site DE3270

Hannover, Germany, 30625

Site GB2624

Manchester, United Kingdom, M20 4BX

Site DE4000

Nuertingen, Germany, 72622

Site US3115

Fort Myers, United States, 33908

Site GB3029

Bristol, United Kingdom, BS2 8HW

Site US1838

West Des Moines, United States, 50266

Site US3182

Bethesda, United States, 20889-5600

Site US2977

Highland, United States, 92346

Site DK3354

Aalborg, Denmark, 9000

Site CA170

Montreal, Canada, H3G 1A4

Site CA2984

Granby, Canada, J2G 8Z9

Site DE2994

Bonn, Germany, 53117

Site BE1322

Gent, Belgium, 9000

Site FR3003

Poitiers Cedex, France, 86000

Site RO3039

Bucharest, Romania, 050659

Site CA3104

Calgary, Canada, T2V 1P9

Site BE3013

Turnhout, Belgium, 2300

Site US1675

Rochester, United States, 14642

Site RO3035

Bucharest, Romania, 041345

Site US1684

New York City, United States, 10016

Site US20

Minneapolis, United States, 55455

Site US1709

Wenatchee, United States, 98801

Site US3634

Greenbelt, United States, 20770

Site US3078

Billings, United States, 59101

Site US3077

Gainesville, United States, 32608

Site FR3000

Rennes Cedex, France, 35033

Site US3629

Tucson, United States, 85741

Site US464

Houston, United States, 77030

Site US1527

Anchorage, United States, 99503

Site US3026

Tucson, United States, 85715

Site US81

Chapel Hill, United States, 27599

Site US51

Milwaukee, United States, 53226

Site GB3027

London, United Kingdom, SE19RT

Site CA2973

Montreal, Canada, H2Z 1N2

Site CA2646

Kingston, Canada, K7L 2V7

Site GB3290

Preston, United Kingdom, PR2 9HT

Site US2104

Greensboro, United States, 27403

Site US2934

Staten Island, United States, 10304

Site US1657

Nashville, United States, 37209

Site US1934

Homewood, United States, 35209

Site US2926

Myrtle Beach, United States, 29572

Site US2969

Greenbelt, United States, 20770

Site GB3355

Merseyside, United Kingdom, CH63 4JY

Site US1653

Virginia Beach, United States, 23462

Site US2975

Ann Arbor, United States, 48109

Site FR3009

Lille, France, 59037

Site US2027

Jeffersonville, United States, 47130

Site US1649

Marietta, United States, 30060

Site FR3007

Rouen, France, 76031

Site GB3244

Belfast, United Kingdom, BT9 7AB

Site US2968

Lawrenceville, United States, 08648

Site FR1091

Creteil, France, 94010

Site RO3042

Bucharest, Romania, 022328

Site BE3018

Kortrijk, Belgium, 8500

Site DK1857

Copenhagen, Denmark, 2200

Site DE2990

Hamburg, Germany, 22081

Site US2180

Fort Wayne, United States, 46825

Site US2935

Denver, United States, 80211

Site US1680

Lancaster, United States, 17604

Site US2976

Baltimore, United States, 21201

Site US2978

San Antonio, United States, 78229

Site DE3286

Waldshut-Tiengen, Germany, 29761

Site GB1862

Leicher, United Kingdom, LE5 4PW

Site FR3002

Paris Cedex 10, France, 75020

Site DK1263

Herlev, Denmark, 2730

Site DE2995

Bonn, Germany, 53111

Site US2067

Springfield, United States, 62703

Site US3630

San Diego, United States, 92123

Site DE2992

Reutlingen, Germany, 72764

Site BE3288

Leuven, Belgium, 3000

Site GB3163

London, United Kingdom, NW1 2PG

Site FR3005

Suresnes Cedex, France, 92151

Site FR442

Lyon Cedex 3, France, 69437

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