Study summary

The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study also evaluated the safety of enzalutamide plus ADT in mHSPC.

Additional Study Details

Phase
Phase 3
Product
enzalutamide
Product
Enzalutamide
Placebo
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment number
1150
Show Additional Study Details

Study documents

Scientific Results Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English
Protocol
Available Language(s): English
Statistical Analysis Plan (SAP)
Available Language(s): English

Get more information

Would you like more information about clinical trial sites that are recruiting participants for A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC)? Contact us by filling out your information to the right and we’ll respond to you.

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    Locations

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    Active, not recruiting
    Site IT39005
    Meldola, Emilia-Romagna, Italy
    Active, not recruiting
    Site BE32012
    Gent, Oost-Vlaanderen, Belgium
    Active, not recruiting
    Site SK42109
    Kosice, Slovakia
    Active, not recruiting
    Site SE46004
    Sundsvall, Vasternorrlands lan, Sweden
    Withdrawn
    Site CA15001
    Kitchener, ON, Canada, N2N 2B9
    Active, not recruiting
    Site NL31003
    Nijmegen, Gelderland, Netherlands
    Active, not recruiting
    Site CA15024
    Abbotsford, BC, Canada, V2S 3N6
    Active, not recruiting
    Site CL56004
    Reñaca, Viña Del Mar, Chile
    Active, not recruiting
    Site DK45003
    Herlev, Denmark
    Active, not recruiting
    Site US10048
    Saint Petersburg, FL, United States, 33710
    Active, not recruiting
    Site FR33009
    Quimper, France
    Active, not recruiting
    Site BE32008
    Liege, Belgium
    Active, not recruiting
    Site AU61015
    Clayton, VIC, Australia
    Withdrawn
    Site IL97207
    Afula, Israel
    Withdrawn
    Site CA15007
    Toronto, ON, Canada, M4N 3M5
    Withdrawn
    Site US10052
    Evergreen park, IL, United States, 60805
    Withdrawn
    Site AU61003
    Perth, WA, Australia, 6000
    Withdrawn
    Site DE49006
    Tübingen, Germany
    Active, not recruiting
    Site US10054
    Thomasville, GA, United States, 31792
    Completed
    Site US10007
    Anchorage, AK, United States, 99503
    Active, not recruiting
    Site SE46001
    Malmö, Skåne län, Sweden
    Active, not recruiting
    Site US10012
    Myrtle Beach, SC, United States, 29572
    Active, not recruiting
    Site US10043
    Springfield, IL, United States, 62703
    Active, not recruiting
    Site CA15023
    Granby, QC, Canada, J2G 8Z9
    Active, not recruiting
    Site US10025
    Newburgh, NY, United States, 12550
    Active, not recruiting
    Site JP81007
    Yokohama, Kanagawa, Japan
    Active, not recruiting
    Site RO40006
    Bucharest, Romania
    Withdrawn
    Site US10064
    Geneva, IL, United States, 60134-4200
    Active, not recruiting
    Site DE49014
    Hamburg, Hamburg, Germany, 20246
    Active, not recruiting
    Site AU61007
    St Leonards, New South Wales, Australia, 2065
    Completed
    Site FR33007
    Lyon Cedex 3, France
    Active, not recruiting
    Site AU61001
    Woodville South, SA, Australia, 5011
    Active, not recruiting
    Site ES34007
    Barcelona, Spain
    Active, not recruiting
    Site DK45005
    Aarhus, Midtjylland, Denmark
    Active, not recruiting
    Site TW88607
    Taoyuan, Taiwan, Province of China, 333
    Active, not recruiting
    Site NL31002
    Sneek, Friesland, Netherlands
    Completed
    Site FR33001
    Pierre Benite, France
    Active, not recruiting
    Site PL48005
    Gdańsk, Pomerania, Poland
    Active, not recruiting
    Site US10056
    La Jolla, CA, United States, 92093
    Active, not recruiting
    Site US10035
    Aurora, CO, United States, 80045
    Active, not recruiting
    Site FR33015
    Le Mans Cedex 2, France
    Completed
    Site PL48001
    Myslowice, Poland
    Active, not recruiting
    Site RU70003
    Moscow, Russian Federation
    Active, not recruiting
    Site RO40007
    Brasov, Romania
    Withdrawn
    Site US10024
    Los Angeles, CA, United States, 90048
    Active, not recruiting
    Site US10020
    West Des Moines, IA, United States, 50266
    Terminated
    Site US10018
    Lawrenceville, NJ, United States, 08648
    Active, not recruiting
    Site IT39011
    Trento, Trentino-Alto Adige, Italy, 38100
    Active, not recruiting
    Site KR82003
    Seoul, Republic of Korea
    Active, not recruiting
    Site TW88601
    Kaohsiung, Taiwan, Province of China, 112
    Active, not recruiting
    Site ES34019
    Madrid, Madrid, Spain
    Active, not recruiting
    Site ES34013
    Valencia, Comunidad Valenciana, Spain
    Active, not recruiting
    Site CA15021
    Kingston, ON, Canada, K7L 2V7
    Active, not recruiting
    Site RU70016
    St. Petersburg, Russian Federation
    Active, not recruiting
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    Active, not recruiting
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    Active, not recruiting
    Site JP81011
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    Active, not recruiting
    Site NL31008
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    Active, not recruiting
    Site CL56003
    Santiago, Chile
    Active, not recruiting
    Site US10017
    Towson, MD, United States, 21204
    Active, not recruiting
    Site RU70001
    Moscow, Russian Federation
    Completed
    Site US10026
    Santa Rosa, CA, United States, 95403
    Active, not recruiting
    Site IL97211
    Zerifin, HaMerkaz, Israel
    Completed
    Site KR82004
    Incheon, Republic of Korea
    Withdrawn
    Site DE49018
    Münster, Nordrhein-Westfalen, Germany, 48149
    Active, not recruiting
    Site AU61016
    Camperdown, NSW, Australia, 2050
    Terminated
    Site US10009
    Concord, NC, United States, 28025
    Completed
    Site NZ64008
    Kensington, Northland, New Zealand
    Completed
    Site US10002
    Burien, WA, United States, 98166
    Active, not recruiting
    Site AU61004
    Ballarat, VIC, Australia
    Active, not recruiting
    Site FI35803
    Seinäjoki, Länsi-Suomen lääni, Finland
    Active, not recruiting
    Site FR33010
    Angers, Maine-et-Loire, France
    Active, not recruiting
    Site JP81003
    Sakura, Chiba, Japan
    Active, not recruiting
    Site RU70013
    Ivanovo, Russian Federation
    Active, not recruiting
    Site AU61009
    Tweed Heads, NSW, Australia, 2485
    Active, not recruiting
    Site TW88605
    Taipei, Taiwan, Province of China
    Active, not recruiting
    Site US10004
    Dallas, TX, United States, 75390-9110
    Active, not recruiting
    Site US10014
    Durham, NC, United States, 27710
    Active, not recruiting
    Site US10013
    Seattle, WA, United States, 98101
    Active, not recruiting
    Site IT39006
    Padova, Veneto, Italy
    Active, not recruiting
    Site SK42110
    Bratislava, Slovakia
    Active, not recruiting
    Site GB44002
    Withington, Manchester, United Kingdom
    Withdrawn
    Site NL31004
    Amsterdam, Noord-Holland, Netherlands, 1105 AZ
    Completed
    Site SE46007
    Goteborg, Vastra Gotalands lan, Sweden
    Active, not recruiting
    Site NZ64002
    Dunedin, South Island, New Zealand
    Active, not recruiting
    Site AU61017
    Parkville, VIC, Australia
    Active, not recruiting
    Site SK42107
    Trencin, Slovakia
    Withdrawn
    Site TW88602
    Taipei, Taiwan, Province of China
    Withdrawn
    Site DE49003
    Erlangen, Bayern, Germany, 91054
    Active, not recruiting
    Site CA15013
    Oakville, ON, Canada, L6H 3P1
    Completed
    Site US10034
    Fountain Valley, CA, United States, 92708
    Active, not recruiting
    Site US10016
    Homewood, AL, United States, 35209
    Active, not recruiting
    Site ES34004
    Madrid, Spain
    Active, not recruiting
    Site AR54002
    Rosario, Santa Fe, Argentina, S2000DSV
    Active, not recruiting
    Site AU61008
    St. Albans, VIC, Australia
    Withdrawn
    Site CA15015
    Barrie, ON, Canada, L4M 7G1
    Active, not recruiting
    Site NL31005
    Eindhoven, Noord-Brabant, Netherlands
    Active, not recruiting
    Site ES34014
    Barcelona, Cataluña, Spain
    Completed
    Site NZ64004
    Hamilton, New Zealand
    Withdrawn
    Site AR54004
    Córdoba, Córdoba, Argentina, X5016KEH
    Active, not recruiting
    Site CA15010
    Brampton, ON, Canada, L6T 4S5
    Completed
    Site CL56002
    Temuco, IX Region, Chile
    Completed
    Site RO40011
    Timisoara, Timis, Romania
    Active, not recruiting
    Site KR82002
    Seoul, Republic of Korea
    Active, not recruiting
    Site DK45002
    Copenhagen, Hovestaden, Denmark
    Active, not recruiting
    Site SE46006
    Stockholm, Sodermanlands lan, Sweden
    Active, not recruiting
    Site JP81020
    Niigata, Niigata, Japan
    Active, not recruiting
    Site IT39008
    Pisa, Toscana, Italy
    Active, not recruiting
    Site NL31006
    Rotterdam, Zuid-Holland, Netherlands
    Active, not recruiting
    Site CA15003
    Kelowna, BC, Canada, V1W 4V5
    Active, not recruiting
    Site FR33005
    La Roche sur Yon, France
    Active, not recruiting
    Site IT39004
    Cremona, Lombardia, Italy
    Active, not recruiting
    Site NL31010
    Alkmaar, Noord-Holland, Netherlands
    Completed
    Site BE32001
    Mons, Hainaut, Belgium
    Completed
    Site RU70014
    Moscow, Russian Federation
    Active, not recruiting
    Site JP81012
    Osakasayama, Osaka, Japan
    Active, not recruiting
    Site JP81017
    Ube, Yamaguchi, Japan
    Active, not recruiting
    Site JP81006
    Bunkyo-ku, Tokyo, Japan
    Active, not recruiting
    Site RO40008
    Cluj-Napoca, Cluj, Romania
    Withdrawn
    Site US10037
    Meridian, ID, United States, 83642
    Withdrawn
    Site US10032
    Oxnard, CA, United States, 93030
    Active, not recruiting
    Site JP81005
    Shinjuku-ku, Tokyo, Japan
    Active, not recruiting
    Site US10060
    Greenville, NC, United States, 27834
    Active, not recruiting
    Site PL48010
    Slupsk, Pomorskie, Poland
    Active, not recruiting
    Site CA15020
    Toronto, ON, Canada, M5G 2M9
    Withdrawn
    Site US10001
    Detroit, MI, United States, 48202
    Completed
    Site SK42101
    Poprad, Slovakia
    Active, not recruiting
    Site ES34010
    Sabadell, Barcelona, Spain
    Active, not recruiting
    Site RU70006
    Omsk, Russian Federation
    Active, not recruiting
    Site FR33014
    Caen Cedex 05, France, 14076
    Active, not recruiting
    Site NL31007
    Nijmegen, Gelderland, Netherlands
    Active, not recruiting
    Site SK42106
    Žilina, Slovakia, 012 07
    Active, not recruiting
    Site US10040
    Virginia Beach, VA, United States, 23462
    Withdrawn
    Site AU61014
    Lismore, NSW, Australia, 2480
    Completed
    Site RU70007
    St. Petersburg, Russian Federation
    Completed
    Site US10044
    Middleburg Heights, OH, United States, 44130
    Withdrawn
    Site BE32009
    Roeselare, West-Vlaanderen, Belgium
    Active, not recruiting
    Site IT39003
    Milano, Lombardia, Italy
    Withdrawn
    Site CA15006
    Laval, QC, Canada, H7G 2E6
    Active, not recruiting
    Site US10045
    Jeffersonville, IN, United States, 47130
    Withdrawn
    Site US10031
    Greensboro, NC, United States, 27403
    Active, not recruiting
    Site KR82001
    Seoul, Republic of Korea
    Active, not recruiting
    Site AR54010
    Buenos Aires, Buenos Aires, Argentina, C1180AAX
    Active, not recruiting
    Site NL31009
    Zwolle, Overijssel, Netherlands
    Withdrawn
    Site US10062
    Carmel, IN, United States, 46032
    Active, not recruiting
    Site SK42103
    Nitra, Slovakia, Slovakia
    Withdrawn
    Site RO40004
    Sibiu, Sibiu, Romania
    Active, not recruiting
    Site ES34012
    Barcelona, Cataluña, Spain
    Completed
    Site SE46002
    Örebro, Orebro län, Sweden
    Active, not recruiting
    Site IT39009
    Candiolo, Italy, 10060
    Active, not recruiting
    Site PL48003
    Wroclaw, Dolnoslaskie, Poland
    Active, not recruiting
    Site FR33012
    Lille Cedex, France
    Active, not recruiting
    Site JP81013
    Kita-gun, Kagawa, Japan
    Active, not recruiting
    Site RU70012
    St. Petersburg, Russian Federation
    Active, not recruiting
    Site RO40002
    Floresti, Cluj, Romania
    Active, not recruiting
    Site CL56007
    Providencia, Santiago, Chile
    Withdrawn
    Site NZ64006
    Christchurch, New Zealand
    Active, not recruiting
    Site ES34020
    Oviedo, Asturias, Spain
    Terminated
    Site US10059
    Nashville, TN, United States, 37208
    Active, not recruiting
    Site US10050
    Denver, CO, United States, 80220
    Withdrawn
    Site US10039
    Gaithersburg, MD, United States, 20879
    Active, not recruiting
    Site PL48011
    Warszawa, Mazowieckie, Poland
    Active, not recruiting
    Site FR33006
    Bordeaux, France
    Active, not recruiting
    Site JP81015
    Fukuoka, Fukuoka, Japan
    Active, not recruiting
    Site PL48007
    Krakow, Malopolskie, Poland
    Active, not recruiting
    Site IT39007
    Novara, Piemonte, Italy
    Active, not recruiting
    Site US10011
    Lancaster, PA, United States, 17604
    Active, not recruiting
    Site JP81014
    Fukuoka, Fukuoka, Japan
    Active, not recruiting
    Site US10055
    Kansas City, KS, United States, 66160-7233
    Active, not recruiting
    Site FI35804
    Pori, Länsi-Suomen lääni, Finland
    Active, not recruiting
    Site US10029
    Syracuse, NY, United States, 13210
    Active, not recruiting
    Site NZ64005
    Nelson, Tasman District, New Zealand
    Active, not recruiting
    Site FI35805
    Oulu, Finland
    Active, not recruiting
    Site RU70008
    St. Petersburg, Russian Federation
    Active, not recruiting
    Site CA15004
    Montreal, QC, Canada, H3T1E2
    Withdrawn
    Site US10003
    Garden City, NY, United States, 11530
    Active, not recruiting
    Site RU70009
    St. Petersburg, Russian Federation
    Active, not recruiting
    Site JP81010
    Abeno-ku, Osaka, Japan
    Active, not recruiting
    Site CL56001
    Santiago, RM, Chile
    Active, not recruiting
    Site KR82008
    Seongnam-si, Gyeonggi-do, Republic of Korea
    Active, not recruiting
    Site JP81016
    Sendai, Miyagi, Japan
    Active, not recruiting
    Site BE32007
    Yvoir, Belgium
    Withdrawn
    Site JP81009
    Suita, Osaka, Japan
    Active, not recruiting
    Site FI35801
    Tampere, Oulun laani, Finland
    Completed
    Site AU61013
    Waratah, NSW, Australia, 2298
    Active, not recruiting
    Site IL97201
    Kfar-Saba, HaMerkaz, Israel
    Active, not recruiting
    Site ES34006
    Pamplona, Navarra, Spain
    Active, not recruiting
    Site CL56005
    Viña Del Mar, Valparaiso, Chile
    Completed
    Site FR33011
    Nimes, France
    Active, not recruiting
    Site DE49004
    Nürtingen, Baden-Württemberg, Germany
    Completed
    Site IL97202
    Haifa, Israel
    Completed
    Site NZ64003
    Tauranga, Bay of Plenty, New Zealand
    Active, not recruiting
    Site DK45004
    Aalborg, Nordjylland, Denmark
    Active, not recruiting
    Site US10036
    Omaha, NE, United States, 68114
    Active, not recruiting
    Site IL97205
    Haifa, Israel
    Withdrawn
    Site IT39001
    Aviano, Pordenone, Italy
    Active, not recruiting
    Site RO40009
    Cluj-Napoca, Cluj, Romania
    Active, not recruiting
    Site JP81008
    Kyoto, Kyoto, Japan
    Active, not recruiting
    Site IL97210
    Beer-Sheva, Israel
    Completed
    Site FI35802
    Helsinki, Etelä-Suomen lääni, Finland
    Active, not recruiting
    Site TW88606
    Taichung, Taiwan, Province of China, 40705
    Active, not recruiting
    Site IT39012
    Milano, Lombardia, Italy
    Completed
    Site DE49002
    Freiburg, Baden-Württemberg, Germany
    Active, not recruiting
    Site CA15022
    Kelowna, BC, Canada, V1Y 5L3
    Active, not recruiting
    Site DK45008
    Holstebro, Midtjylland, Denmark
    Withdrawn
    Site US10041
    New Haven, CT, United States, 06510
    Withdrawn
    Site DE49001
    Hamburg, Germany
    Withdrawn
    Site PL48008
    Warszawa, Mazowieckie, Poland
    Withdrawn
    Site BE32006
    Turnhout, Belgium
    Active, not recruiting
    Site BE32005
    Kortrijk, West-Vlaanderen, Belgium
    Withdrawn
    Site AU61005
    Adelaide, SA, Australia, 5042
    Completed
    Site US10068
    Charlotte, NC, United States, 28207
    Withdrawn
    Site US10049
    Spokane, WA, United States, 99202
    Active, not recruiting
    Site AU61006
    Sydney, NSW, Australia
    Active, not recruiting
    Site RO40003
    Bucharest, Romania
    Active, not recruiting
    Site JP81004
    Koto-ku, Tokyo, Japan
    Active, not recruiting
    Site US10046
    Dallas, TX, United States, 75231
    Withdrawn
    Site AU61011
    Garran, Australian Capital Territory, Australia, 2605
    Completed
    Site US10028
    Wenatchee, WA, United States, 98801
    Withdrawn
    Site ES34018
    Santiago de Compostela, A Coruna, Spain
    Active, not recruiting
    Site IL97206
    Jerusalem, Israel
    Withdrawn
    Site FR33002
    Lyon Cedex 09, Rhône, France
    Active, not recruiting
    Site US10008
    Tucson, AZ, United States, 85741
    Active, not recruiting
    Site AR54007
    San Miguel de Tucuman, Tucuman, Argentina, 4000
    Active, not recruiting
    Site JP81002
    Chiba, Chiba, Japan
    Active, not recruiting
    Site FR33003
    Creteil, Val-de-Marne, France, 94010
    Active, not recruiting
    Site DE49005
    Bonn, Germany, 53111
    Withdrawn
    Site US10023
    Jefferson City, Mo, United States, 65109
    Active, not recruiting
    Site ES34011
    Salamanca, A Coruña, Spain
    Active, not recruiting
    Site FI35807
    Turku, Finland
    Active, not recruiting
    Site DE49013
    Heidelberg, Germany, 69120
    Active, not recruiting
    Site US10015
    Chicago, IL, United States, 60637
    Active, not recruiting
    Site FR33013
    Saint Mande, France
    Active, not recruiting
    Site SK42102
    Michalovce, Slovakia
    Completed
    Site ES34001
    Avila, Avila, Spain
    Active, not recruiting
    Site DK45001
    Odense C, Denmark
    Completed
    Site RU70005
    Penza, Russian Federation
    Active, not recruiting
    Site JP81018
    Nagasaki, Nagasaki, Japan
    Active, not recruiting
    Site KR82007
    Busan, Republic of Korea
    Active, not recruiting
    Site FI35806
    Pietarsaari, Finland
    Active, not recruiting
    Site JP81019
    Yamagata, Yamagata, Japan

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