Study Details

A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

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.
NCT02677896

Astellas Study ID

The unique identification code given by the study sponsor.

9785-CL-0335

EudraCT ID

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

2015-003869-28

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

Mar 2016 - Feb 2024

Masking

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

Enrollment number

1150

A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

Study summary

Get More Information

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Locations

Site IT39005

Meldola, Italy

Site BE32012

Gent, Belgium

Site SK42109

Kosice, Slovakia

Site SE46004

Sundsvall, Sweden

Site CA15001

Kitchener, Canada, N2N 2B9

Site NL31003

Nijmegen, Netherlands

Site CA15024

Abbotsford, Canada, V2S 3N6

Site CL56004

Reñaca, Chile

Site DK45003

Herlev, Denmark

Site US10048

Saint Petersburg, United States, 33710

Site FR33009

Quimper, France

Site BE32008

Liege, Belgium

Site AU61015

Clayton, Australia

Site IL97207

Afula, Israel

Site CA15007

Toronto, Canada, M4N 3M5

Site US10052

Evergreen park, United States, 60805

Site AU61003

Perth, Australia, 6000

Site DE49006

Tübingen, Germany

Site US10054

Thomasville, United States, 31792

Site US10007

Anchorage, United States, 99503

Site SE46001

Malmö, Sweden

Site US10012

Myrtle Beach, United States, 29572

Site US10043

Springfield, United States, 62703

Site CA15023

Granby, Canada, J2G 8Z9

Site US10025

Newburgh, United States, 12550

Site JP81007

Yokohama, Japan

Site RO40006

Bucharest, Romania

Site US10064

Geneva, United States, 60134-4200

Site DE49014

Hamburg, Germany, 20246

Site AU61007

St Leonards, Australia, 2065

Site FR33007

Lyon Cedex 3, France

Site AU61001

Woodville South, Australia, 5011

Site ES34007

Barcelona, Spain

Site DK45005

Aarhus, Denmark

Site TW88607

Taoyuan, Taiwan, Province of China, 333

Site NL31002

Sneek, Netherlands

Site FR33001

Pierre Benite, France

Site PL48005

Gdańsk, Poland

Site US10056

La Jolla, United States, 92093

Site US10035

Aurora, United States, 80045

Site FR33015

Le Mans Cedex 2, France

Site PL48001

Myslowice, Poland

Site RU70003

Moscow, Russian Federation

Site RO40007

Brasov, Romania

Site US10024

Los Angeles, United States, 90048

Site US10020

West Des Moines, United States, 50266

Site US10018

Lawrenceville, United States, 08648

Site IT39011

Trento, Italy, 38100

Site KR82003

Seoul, Republic of Korea

Site TW88601

Kaohsiung, Taiwan, Province of China, 112

Site ES34019

Madrid, Spain

Site ES34013

Valencia, Spain

Site CA15021

Kingston, Canada, K7L 2V7

Site RU70016

St. Petersburg, Russian Federation

Site JP81001

Maebashi, Japan

Site CA15016

Edmonton, Canada, T6G 1Z2

Site JP81011

Chuo-ku, Japan

Site NL31008

Amsterdam, Netherlands

Site CL56003

Santiago, Chile

Site US10017

Towson, United States, 21204

Site RU70001

Moscow, Russian Federation

Site US10026

Santa Rosa, United States, 95403

Site IL97211

Zerifin, Israel

Site KR82004

Incheon, Republic of Korea

Site DE49018

Münster, Germany, 48149

Site AU61016

Camperdown, Australia, 2050

Site US10009

Concord, United States, 28025

Site NZ64008

Kensington, New Zealand

Site US10002

Burien, United States, 98166

Site AU61004

Ballarat, Australia

Site FI35803

Seinäjoki, Finland

Site FR33010

Angers, France

Site JP81003

Sakura, Japan

Site RU70013

Ivanovo, Russian Federation

Site AU61009

Tweed Heads, Australia, 2485

Site TW88605

Taipei, Taiwan, Province of China

Site US10004

Dallas, United States, 75390-9110

Site US10014

Durham, United States, 27710

Site US10013

Seattle, United States, 98101

Site IT39006

Padova, Italy

Site SK42110

Bratislava, Slovakia

Site GB44002

Withington, United Kingdom

Site NL31004

Amsterdam, Netherlands, 1105 AZ

Site SE46007

Goteborg, Sweden

Site NZ64002

Dunedin, New Zealand

Site AU61017

Parkville, Australia

Site SK42107

Trencin, Slovakia

Site TW88602

Taipei, Taiwan, Province of China

Site DE49003

Erlangen, Germany, 91054

Site CA15013

Oakville, Canada, L6H 3P1

Site US10034

Fountain Valley, United States, 92708

Site US10016

Homewood, United States, 35209

Site ES34004

Madrid, Spain

Site AR54002

Rosario, Argentina, S2000DSV

Site AU61008

St. Albans, Australia

Site CA15015

Barrie, Canada, L4M 7G1

Site NL31005

Eindhoven, Netherlands

Site ES34014

Barcelona, Spain

Site NZ64004

Hamilton, New Zealand

Site AR54004

Córdoba, Argentina, X5016KEH

Site CA15010

Brampton, Canada, L6T 4S5

Site CL56002

Temuco, Chile

Site RO40011

Timisoara, Romania

Site KR82002

Seoul, Republic of Korea

Site DK45002

Copenhagen, Denmark

Site SE46006

Stockholm, Sweden

Site JP81020

Niigata, Japan

Site IT39008

Pisa, Italy

Site NL31006

Rotterdam, Netherlands

Site CA15003

Kelowna, Canada, V1W 4V5

Site FR33005

La Roche sur Yon, France

Site IT39004

Cremona, Italy

Site NL31010

Alkmaar, Netherlands

Site BE32001

Mons, Belgium

Site RU70014

Moscow, Russian Federation

Site JP81012

Osakasayama, Japan

Site JP81017

Ube, Japan

Site JP81006

Bunkyo-ku, Japan

Site RO40008

Cluj-Napoca, Romania

Site US10037

Meridian, United States, 83642

Site US10032

Oxnard, United States, 93030

Site JP81005

Shinjuku-ku, Japan

Site US10060

Greenville, United States, 27834

Site PL48010

Slupsk, Poland

Site CA15020

Toronto, Canada, M5G 2M9

Site US10001

Detroit, United States, 48202

Site SK42101

Poprad, Slovakia

Site ES34010

Sabadell, Spain

Site RU70006

Omsk, Russian Federation

Site FR33014

Caen Cedex 05, France, 14076

Site NL31007

Nijmegen, Netherlands

Site SK42106

Žilina, Slovakia, 012 07

Site US10040

Virginia Beach, United States, 23462

Site AU61014

Lismore, Australia, 2480

Site RU70007

St. Petersburg, Russian Federation

Site US10044

Middleburg Heights, United States, 44130

Site BE32009

Roeselare, Belgium

Site IT39003

Milano, Italy

Site CA15006

Laval, Canada, H7G 2E6

Site US10045

Jeffersonville, United States, 47130

Site US10031

Greensboro, United States, 27403

Site KR82001

Seoul, Republic of Korea

Site AR54010

Buenos Aires, Argentina, C1180AAX

Site NL31009

Zwolle, Netherlands

Site US10062

Carmel, United States, 46032

Site SK42103

Nitra, Slovakia

Site RO40004

Sibiu, Romania

Site ES34012

Barcelona, Spain

Site SE46002

Örebro, Sweden

Site IT39009

Candiolo, Italy, 10060

Site PL48003

Wroclaw, Poland

Site FR33012

Lille Cedex, France

Site JP81013

Kita-gun, Japan

Site RU70012

St. Petersburg, Russian Federation

Site RO40002

Floresti, Romania

Site CL56007

Providencia, Chile

Site NZ64006

Christchurch, New Zealand

Site ES34020

Oviedo, Spain

Site US10059

Nashville, United States, 37208

Site US10050

Denver, United States, 80220

Site US10039

Gaithersburg, United States, 20879

Site PL48011

Warszawa, Poland

Site FR33006

Bordeaux, France

Site JP81015

Fukuoka, Japan

Site PL48007

Krakow, Poland

Site IT39007

Novara, Italy

Site US10011

Lancaster, United States, 17604

Site JP81014

Fukuoka, Japan

Site US10055

Kansas City, United States, 66160-7233

Site FI35804

Pori, Finland

Site US10029

Syracuse, United States, 13210

Site NZ64005

Nelson, New Zealand

Site FI35805

Oulu, Finland

Site RU70008

St. Petersburg, Russian Federation

Site CA15004

Montreal, Canada, H3T1E2

Site US10003

Garden City, United States, 11530

Site RU70009

St. Petersburg, Russian Federation

Site JP81010

Abeno-ku, Japan

Site CL56001

Santiago, Chile

Site KR82008

Seongnam-si, Republic of Korea

Site JP81016

Sendai, Japan

Site BE32007

Yvoir, Belgium

Site JP81009

Suita, Japan

Site FI35801

Tampere, Finland

Site AU61013

Waratah, Australia, 2298

Site IL97201

Kfar-Saba, Israel

Site ES34006

Pamplona, Spain

Site CL56005

Viña Del Mar, Chile

Site FR33011

Nimes, France

Site DE49004

Nürtingen, Germany

Site IL97202

Haifa, Israel

Site NZ64003

Tauranga, New Zealand

Site DK45004

Aalborg, Denmark

Site US10036

Omaha, United States, 68114

Site IL97205

Haifa, Israel

Site IT39001

Aviano, Italy

Site RO40009

Cluj-Napoca, Romania

Site JP81008

Kyoto, Japan

Site IL97210

Beer-Sheva, Israel

Site FI35802

Helsinki, Finland

Site TW88606

Taichung, Taiwan, Province of China, 40705

Site IT39012

Milano, Italy

Site DE49002

Freiburg, Germany

Site CA15022

Kelowna, Canada, V1Y 5L3

Site DK45008

Holstebro, Denmark

Site US10041

New Haven, United States, 06510

Site DE49001

Hamburg, Germany

Site PL48008

Warszawa, Poland

Site BE32006

Turnhout, Belgium

Site BE32005

Kortrijk, Belgium

Site AU61005

Adelaide, Australia, 5042

Site US10068

Charlotte, United States, 28207

Site US10049

Spokane, United States, 99202

Site AU61006

Sydney, Australia

Site RO40003

Bucharest, Romania

Site JP81004

Koto-ku, Japan

Site US10046

Dallas, United States, 75231

Site AU61011

Garran, Australia, 2605

Site US10028

Wenatchee, United States, 98801

Site ES34018

Santiago de Compostela, Spain

Site IL97206

Jerusalem, Israel

Site FR33002

Lyon Cedex 09, France

Site US10008

Tucson, United States, 85741

Site AR54007

San Miguel de Tucuman, Argentina, 4000

Site JP81002

Chiba, Japan

Site FR33003

Creteil, France, 94010

Site DE49005

Bonn, Germany, 53111

Site US10023

Jefferson City, United States, 65109

Site ES34011

Salamanca, Spain

Site FI35807

Turku, Finland

Site DE49013

Heidelberg, Germany, 69120

Site US10015

Chicago, United States, 60637

Site FR33013

Saint Mande, France

Site SK42102

Michalovce, Slovakia

Site ES34001

Avila, Spain

Site DK45001

Odense C, Denmark

Site RU70005

Penza, Russian Federation

Site JP81018

Nagasaki, Japan

Site KR82007

Busan, Republic of Korea

Site FI35806

Pietarsaari, Finland

Site JP81019

Yamagata, Japan