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
  • Placebo
  • Type
    Interventional
    Masking
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Enrollment number
    1150
    Show Additional Study Details

    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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    • Algeria
    • Argentina
    • Armenia
    • Australia
    • Austria
    • Belarus
    • Belgium
    • Bosnia And Herzegovina
    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
    • Colombia
    • Croatia
    • Czech Republic
    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
    • Finland
    • Former Serbia and Montenegro
    • France
    • Georgia
    • Germany
    • Greece
    • Guatemala
    • Hong Kong
    • Hungary
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    • India
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      Locations

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      Completed
      Site IT39005
      Meldola, Emilia-Romagna, Italy
      Completed
      Site BE32012
      Gent, Oost-Vlaanderen, Belgium
      Completed
      Site SK42109
      Kosice, Slovakia
      Completed
      Site SE46004
      Sundsvall, Vasternorrlands lan, Sweden
      Withdrawn
      Site CA15001
      Kitchener, ON, Canada, N2N 2B9
      Completed
      Site NL31003
      Nijmegen, Gelderland, Netherlands
      Completed
      Site CA15024
      Abbotsford, BC, Canada, V2S 3N6
      Completed
      Site CL56004
      Reñaca, Viña Del Mar, Chile
      Completed
      Site DK45003
      Herlev, Denmark
      Completed
      Site US10048
      Saint Petersburg, FL, United States, 33710
      Completed
      Site FR33009
      Quimper, France
      Completed
      Site BE32008
      Liege, Belgium
      Completed
      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
      Completed
      Site US10054
      Thomasville, GA, United States, 31792
      Completed
      Site US10007
      Anchorage, AK, United States, 99503
      Completed
      Site SE46001
      Malmö, Skåne län, Sweden
      Completed
      Site US10012
      Myrtle Beach, SC, United States, 29572
      Completed
      Site US10043
      Springfield, IL, United States, 62703
      Completed
      Site CA15023
      Granby, QC, Canada, J2G 8Z9
      Completed
      Site US10025
      Newburgh, NY, United States, 12550
      Completed
      Site JP81007
      Yokohama, Kanagawa, Japan
      Completed
      Site RO40006
      Bucharest, Romania
      Withdrawn
      Site US10064
      Geneva, IL, United States, 60134-4200
      Completed
      Site DE49014
      Hamburg, Hamburg, Germany, 20246
      Completed
      Site AU61007
      St Leonards, New South Wales, Australia, 2065
      Completed
      Site FR33007
      Lyon Cedex 3, France
      Completed
      Site AU61001
      Woodville South, SA, Australia, 5011
      Completed
      Site ES34007
      Barcelona, Spain
      Completed
      Site DK45005
      Aarhus, Midtjylland, Denmark
      Completed
      Site TW88607
      Taoyuan, Taiwan, Province of China, 333
      Completed
      Site NL31002
      Sneek, Friesland, Netherlands
      Completed
      Site FR33001
      Pierre Benite, France
      Completed
      Site PL48005
      Gdańsk, Pomerania, Poland
      Completed
      Site US10056
      La Jolla, CA, United States, 92093
      Completed
      Site US10035
      Aurora, CO, United States, 80045
      Completed
      Site FR33015
      Le Mans Cedex 2, France
      Completed
      Site PL48001
      Myslowice, Poland
      Completed
      Site RU70003
      Moscow, Russian Federation
      Completed
      Site RO40007
      Brasov, Romania
      Withdrawn
      Site US10024
      Los Angeles, CA, United States, 90048
      Completed
      Site US10020
      West Des Moines, IA, United States, 50266
      Terminated
      Site US10018
      Lawrenceville, NJ, United States, 08648
      Completed
      Site IT39011
      Trento, Trentino-Alto Adige, Italy, 38100
      Completed
      Site KR82003
      Seoul, Republic of Korea
      Completed
      Site TW88601
      Kaohsiung, Taiwan, Province of China, 112
      Completed
      Site ES34019
      Madrid, Madrid, Spain
      Completed
      Site ES34013
      Valencia, Comunidad Valenciana, Spain
      Completed
      Site CA15021
      Kingston, ON, Canada, K7L 2V7
      Completed
      Site RU70016
      St. Petersburg, Russian Federation
      Completed
      Site JP81001
      Maebashi, Gunma, Japan
      Completed
      Site CA15016
      Edmonton, AB, Canada, T6G 1Z2
      Completed
      Site JP81011
      Chuo-ku, Osaka, Japan
      Completed
      Site NL31008
      Amsterdam, Noord-Holland, Netherlands
      Completed
      Site CL56003
      Santiago, Chile
      Completed
      Site US10017
      Towson, MD, United States, 21204
      Completed
      Site RU70001
      Moscow, Russian Federation
      Completed
      Site US10026
      Santa Rosa, CA, United States, 95403
      Completed
      Site IL97211
      Zerifin, HaMerkaz, Israel
      Completed
      Site KR82004
      Incheon, Republic of Korea
      Withdrawn
      Site DE49018
      Münster, Nordrhein-Westfalen, Germany, 48149
      Completed
      Site AU61016
      Camperdown, NSW, Australia, 2050
      Terminated
      Site US10009
      Concord, NC, United States, 28025
      Completed
      Site NZ64008
      Kensington, Northland, New Zealand
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      Site US10002
      Burien, WA, United States, 98166
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      Site AU61004
      Ballarat, VIC, Australia
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      Site FI35803
      Seinäjoki, Länsi-Suomen lääni, Finland
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      Site FR33010
      Angers, Maine-et-Loire, France
      Completed
      Site JP81003
      Sakura, Chiba, Japan
      Completed
      Site RU70013
      Ivanovo, Russian Federation
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      Site AU61009
      Tweed Heads, NSW, Australia, 2485
      Completed
      Site TW88605
      Taipei, Taiwan, Province of China
      Completed
      Site US10004
      Dallas, TX, United States, 75390-9110
      Completed
      Site US10014
      Durham, NC, United States, 27710
      Completed
      Site US10013
      Seattle, WA, United States, 98101
      Completed
      Site IT39006
      Padova, Veneto, Italy
      Completed
      Site SK42110
      Bratislava, Slovakia
      Completed
      Site GB44002
      Withington, Manchester, United Kingdom
      Withdrawn
      Site NL31004
      Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      Completed
      Site SE46007
      Goteborg, Vastra Gotalands lan, Sweden
      Completed
      Site NZ64002
      Dunedin, South Island, New Zealand
      Completed
      Site AU61017
      Parkville, VIC, Australia
      Completed
      Site SK42107
      Trencin, Slovakia
      Withdrawn
      Site TW88602
      Taipei, Taiwan, Province of China
      Withdrawn
      Site DE49003
      Erlangen, Bayern, Germany, 91054
      Completed
      Site CA15013
      Oakville, ON, Canada, L6H 3P1
      Completed
      Site US10034
      Fountain Valley, CA, United States, 92708
      Completed
      Site US10016
      Homewood, AL, United States, 35209
      Completed
      Site ES34004
      Madrid, Spain
      Completed
      Site AR54002
      Rosario, Santa Fe, Argentina, S2000DSV
      Completed
      Site AU61008
      St. Albans, VIC, Australia
      Withdrawn
      Site CA15015
      Barrie, ON, Canada, L4M 7G1
      Completed
      Site NL31005
      Eindhoven, Noord-Brabant, Netherlands
      Completed
      Site ES34014
      Barcelona, Cataluña, Spain
      Completed
      Site NZ64004
      Hamilton, New Zealand
      Withdrawn
      Site AR54004
      Córdoba, Córdoba, Argentina, X5016KEH
      Completed
      Site CA15010
      Brampton, ON, Canada, L6T 4S5
      Completed
      Site CL56002
      Temuco, IX Region, Chile
      Completed
      Site RO40011
      Timisoara, Timis, Romania
      Completed
      Site KR82002
      Seoul, Republic of Korea
      Completed
      Site DK45002
      Copenhagen, Hovestaden, Denmark
      Completed
      Site SE46006
      Stockholm, Sodermanlands lan, Sweden
      Completed
      Site JP81020
      Niigata, Niigata, Japan
      Completed
      Site IT39008
      Pisa, Toscana, Italy
      Completed
      Site NL31006
      Rotterdam, Zuid-Holland, Netherlands
      Completed
      Site CA15003
      Kelowna, BC, Canada, V1W 4V5
      Completed
      Site FR33005
      La Roche sur Yon, France
      Completed
      Site IT39004
      Cremona, Lombardia, Italy
      Completed
      Site NL31010
      Alkmaar, Noord-Holland, Netherlands
      Completed
      Site BE32001
      Mons, Hainaut, Belgium
      Completed
      Site RU70014
      Moscow, Russian Federation
      Completed
      Site JP81012
      Osakasayama, Osaka, Japan
      Completed
      Site JP81017
      Ube, Yamaguchi, Japan
      Completed
      Site JP81006
      Bunkyo-ku, Tokyo, Japan
      Completed
      Site RO40008
      Cluj-Napoca, Cluj, Romania
      Withdrawn
      Site US10037
      Meridian, ID, United States, 83642
      Withdrawn
      Site US10032
      Oxnard, CA, United States, 93030
      Completed
      Site JP81005
      Shinjuku-ku, Tokyo, Japan
      Completed
      Site US10060
      Greenville, NC, United States, 27834
      Completed
      Site PL48010
      Slupsk, Pomorskie, Poland
      Completed
      Site CA15020
      Toronto, ON, Canada, M5G 2M9
      Withdrawn
      Site US10001
      Detroit, MI, United States, 48202
      Completed
      Site SK42101
      Poprad, Slovakia
      Completed
      Site ES34010
      Sabadell, Barcelona, Spain
      Completed
      Site RU70006
      Omsk, Russian Federation
      Completed
      Site FR33014
      Caen Cedex 05, France, 14076
      Completed
      Site NL31007
      Nijmegen, Gelderland, Netherlands
      Completed
      Site SK42106
      Žilina, Slovakia, 012 07
      Completed
      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
      Completed
      Site IT39003
      Milano, Lombardia, Italy
      Withdrawn
      Site CA15006
      Laval, QC, Canada, H7G 2E6
      Completed
      Site US10045
      Jeffersonville, IN, United States, 47130
      Withdrawn
      Site US10031
      Greensboro, NC, United States, 27403
      Completed
      Site KR82001
      Seoul, Republic of Korea
      Completed
      Site AR54010
      Buenos Aires, Buenos Aires, Argentina, C1180AAX
      Completed
      Site NL31009
      Zwolle, Overijssel, Netherlands
      Withdrawn
      Site US10062
      Carmel, IN, United States, 46032
      Completed
      Site SK42103
      Nitra, Slovakia, Slovakia
      Withdrawn
      Site RO40004
      Sibiu, Sibiu, Romania
      Completed
      Site ES34012
      Barcelona, Cataluña, Spain
      Completed
      Site SE46002
      Örebro, Orebro län, Sweden
      Completed
      Site IT39009
      Candiolo, Italy, 10060
      Completed
      Site PL48003
      Wroclaw, Dolnoslaskie, Poland
      Completed
      Site FR33012
      Lille Cedex, France
      Completed
      Site JP81013
      Kita-gun, Kagawa, Japan
      Completed
      Site RU70012
      St. Petersburg, Russian Federation
      Completed
      Site RO40002
      Floresti, Cluj, Romania
      Completed
      Site CL56007
      Providencia, Santiago, Chile
      Withdrawn
      Site NZ64006
      Christchurch, New Zealand
      Completed
      Site ES34020
      Oviedo, Asturias, Spain
      Terminated
      Site US10059
      Nashville, TN, United States, 37208
      Completed
      Site US10050
      Denver, CO, United States, 80220
      Withdrawn
      Site US10039
      Gaithersburg, MD, United States, 20879
      Completed
      Site PL48011
      Warszawa, Mazowieckie, Poland
      Completed
      Site FR33006
      Bordeaux, France
      Completed
      Site JP81015
      Fukuoka, Fukuoka, Japan
      Completed
      Site PL48007
      Krakow, Malopolskie, Poland
      Completed
      Site IT39007
      Novara, Piemonte, Italy
      Completed
      Site US10011
      Lancaster, PA, United States, 17604
      Completed
      Site JP81014
      Fukuoka, Fukuoka, Japan
      Completed
      Site US10055
      Kansas City, KS, United States, 66160-7233
      Completed
      Site FI35804
      Pori, Länsi-Suomen lääni, Finland
      Completed
      Site US10029
      Syracuse, NY, United States, 13210
      Completed
      Site NZ64005
      Nelson, Tasman District, New Zealand
      Completed
      Site FI35805
      Oulu, Finland
      Completed
      Site RU70008
      St. Petersburg, Russian Federation
      Completed
      Site CA15004
      Montreal, QC, Canada, H3T1E2
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      Site US10003
      Garden City, NY, United States, 11530
      Completed
      Site RU70009
      St. Petersburg, Russian Federation
      Completed
      Site JP81010
      Abeno-ku, Osaka, Japan
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      Site CL56001
      Santiago, RM, Chile
      Completed
      Site KR82008
      Seongnam-si, Gyeonggi-do, Republic of Korea
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      Site JP81016
      Sendai, Miyagi, Japan
      Completed
      Site BE32007
      Yvoir, Belgium
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      Site JP81009
      Suita, Osaka, Japan
      Completed
      Site FI35801
      Tampere, Oulun laani, Finland
      Completed
      Site AU61013
      Waratah, NSW, Australia, 2298
      Completed
      Site IL97201
      Kfar-Saba, HaMerkaz, Israel
      Completed
      Site ES34006
      Pamplona, Navarra, Spain
      Completed
      Site CL56005
      Viña Del Mar, Valparaiso, Chile
      Completed
      Site FR33011
      Nimes, France
      Completed
      Site DE49004
      Nürtingen, Baden-Württemberg, Germany
      Completed
      Site IL97202
      Haifa, Israel
      Completed
      Site NZ64003
      Tauranga, Bay of Plenty, New Zealand
      Completed
      Site DK45004
      Aalborg, Nordjylland, Denmark
      Completed
      Site US10036
      Omaha, NE, United States, 68114
      Completed
      Site IL97205
      Haifa, Israel
      Withdrawn
      Site IT39001
      Aviano, Pordenone, Italy
      Completed
      Site RO40009
      Cluj-Napoca, Cluj, Romania
      Completed
      Site JP81008
      Kyoto, Kyoto, Japan
      Completed
      Site IL97210
      Beer-Sheva, Israel
      Completed
      Site FI35802
      Helsinki, Etelä-Suomen lääni, Finland
      Completed
      Site TW88606
      Taichung, Taiwan, Province of China, 40705
      Completed
      Site IT39012
      Milano, Lombardia, Italy
      Completed
      Site DE49002
      Freiburg, Baden-Württemberg, Germany
      Completed
      Site CA15022
      Kelowna, BC, Canada, V1Y 5L3
      Completed
      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
      Completed
      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
      Completed
      Site AU61006
      Sydney, NSW, Australia
      Completed
      Site RO40003
      Bucharest, Romania
      Completed
      Site JP81004
      Koto-ku, Tokyo, Japan
      Completed
      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
      Completed
      Site IL97206
      Jerusalem, Israel
      Withdrawn
      Site FR33002
      Lyon Cedex 09, Rhône, France
      Completed
      Site US10008
      Tucson, AZ, United States, 85741
      Completed
      Site AR54007
      San Miguel de Tucuman, Tucuman, Argentina, 4000
      Completed
      Site JP81002
      Chiba, Chiba, Japan
      Completed
      Site FR33003
      Creteil, Val-de-Marne, France, 94010
      Completed
      Site DE49005
      Bonn, Germany, 53111
      Withdrawn
      Site US10023
      Jefferson City, MO, United States, 65109
      Completed
      Site ES34011
      Salamanca, A Coruña, Spain
      Completed
      Site FI35807
      Turku, Finland
      Completed
      Site DE49013
      Heidelberg, Germany, 69120
      Completed
      Site US10015
      Chicago, IL, United States, 60637
      Completed
      Site FR33013
      Saint Mande, France
      Completed
      Site SK42102
      Michalovce, Slovakia
      Completed
      Site ES34001
      Avila, Avila, Spain
      Completed
      Site DK45001
      Odense C, Denmark
      Completed
      Site RU70005
      Penza, Russian Federation
      Completed
      Site JP81018
      Nagasaki, Nagasaki, Japan
      Completed
      Site KR82007
      Busan, Republic of Korea
      Completed
      Site FI35806
      Pietarsaari, Finland
      Completed
      Site JP81019
      Yamagata, Yamagata, Japan

      Frequently Asked Questions

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      Should I be worried about getting a placebo?

      In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

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