Phase
Condition
Prostate Cancer
Allergies & Asthma
Allergy (Pediatric)
Treatment
Docetaxel
Standard ADT (androgen deprivation therapy)
Placebo
Clinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of prostate.
- Metastatic disease
- Candidates for ADT and docetaxel.
- Started ADT with or without first generation anti androgen, but no longer than 12weeks before randomization
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow, liver and renal function
Exclusion
Exclusion Criteria:
- Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), otherinvestigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate ororal ketoconazole as antineoplastic treatment for prostate cancer; chemotherapy orimmunotherapy for prostate cancer prior to randomization.
- Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.
- Had any of the following within 6 months before randomization: stroke, myocardialinfarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft,congestive heart failure (New York Heart Association Class III or IV)
- Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma ofskin or superficial bladder cancer that has not spread behind the connective tissuelayer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for whichtreatment has been completed 5 years before randomization and from which the subjecthas been disease-free
- Gastrointestinal disorder or procedure which is expected to interfere significantlywith absorption of study treatment.
- Inability to swallow oral medications
Study Design
Study Description
Connect with a study center
Randwick, New South Wales 2031
AustraliaSite Not Available
Sydney, New South Wales 2010
AustraliaSite Not Available
Adelaide, South Australia 5000
AustraliaSite Not Available
Kurralta Park, South Australia 5037
AustraliaSite Not Available
Fitzroy, Victoria 3065
AustraliaSite Not Available
empty
Melbourne, Victoria 3065
AustraliaSite Not Available
Melbourne, Victoria 3065
AustraliaSite Not Available
empty
Nedlands, Western Australia 6009
AustraliaSite Not Available
Wilrijk, Antwerpen 2610
BelgiumSite Not Available
empty
Antwerpen, 2020
BelgiumSite Not Available
Brussels, 1070
BelgiumSite Not Available
Bruxelles - Brussel, 1200
BelgiumSite Not Available
Charleroi, 6000
BelgiumSite Not Available
Gent, 9000
BelgiumSite Not Available
Namur, 5000
BelgiumSite Not Available
Salvador, Bahia 41253-190
BrazilSite Not Available
Cachoeiro de Itapemirim, Espírito Santo 29308-020
BrazilSite Not Available
empty
Belo Horizonte, Minas Gerais 30150-320
BrazilSite Not Available
Curitiba, Parana 81520-060
BrazilSite Not Available
Natal, Rio Grande Do Norte 59062-000
BrazilSite Not Available
Porto Alegre, Rio Grande Do Sul 90050 170
BrazilSite Not Available
Santo André, Sao Paulo 09060-650
BrazilSite Not Available
São Paulo, Sao Paulo 04014-002
BrazilSite Not Available
Rio de Janeiro, 20231-050
BrazilSite Not Available
empty
Sao Paulo, 01308-050
BrazilSite Not Available
Gabrovo, 5300
BulgariaSite Not Available
Pleven, 5809
BulgariaSite Not Available
empty
Plovdiv, 4004
BulgariaSite Not Available
Sofia, 1303
BulgariaSite Not Available
Varna, 9010
BulgariaSite Not Available
Vratsa, 3000
BulgariaSite Not Available
Calgary, Alberta T2N 4N2
CanadaSite Not Available
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
Toronto, Ontario M4N 3M5
CanadaSite Not Available
Montreal, Quebec H2L 4M1
CanadaSite Not Available
empty
Hefei, Anhui 230001
ChinaSite Not Available
Hefei, Anhui 230001
ChinaSite Not Available
Hefei City, Anhui Province, Anhui 230031
ChinaSite Not Available
Xiamen, Fujian 361003
ChinaSite Not Available
Guangzhou, Guangdong 510120
ChinaSite Not Available
Shijiazhuang, Hebei 050000
ChinaSite Not Available
Zhengzhou, Henan 450000
ChinaSite Not Available
Wuhan, Hubei 430079
ChinaSite Not Available
Changsha, Hunan 410013
ChinaSite Not Available
Nanjing, Jiangsu 210008
ChinaSite Not Available
Nanchang, Jiangxi 330006
ChinaSite Not Available
empty
Changchun, Jilin 130000
ChinaSite Not Available
Changchun, Jilin 130000
ChinaSite Not Available
Changchun City, Jilin 130061
ChinaSite Not Available
Shengyang, Liaoning 110042
ChinaSite Not Available
Shenyang, Liaoning 110001
ChinaSite Not Available
Xi'an, Shaanxi 710061
ChinaSite Not Available
Jinan, Shandong 250021
ChinaSite Not Available
Yantai, Shandong 264000
ChinaSite Not Available
Hangzhou, Zhejiang 310009
ChinaSite Not Available
Wenzhou, Zhejiang 325000
ChinaSite Not Available
Beijing, 100730
ChinaSite Not Available
Chongqing, 400030
ChinaSite Not Available
Shanghai, 200080
ChinaSite Not Available
Tianjin, 300052
ChinaSite Not Available
empty
Hradec Kralove, 500 05
Czech RepublicSite Not Available
Brno, 602 00
CzechiaSite Not Available
Praha 10, 10034
CzechiaSite Not Available
Praha 2, 128 08
CzechiaSite Not Available
Praha 5, 150 06
CzechiaSite Not Available
Praha 8, 180 81
CzechiaSite Not Available
empty
HUS, 00029
FinlandSite Not Available
Helsinki, 00290
FinlandSite Not Available
Jyväskylä, 40620
FinlandSite Not Available
Kuopio, 70210
FinlandSite Not Available
Mikkeli, FIN-50100
FinlandSite Not Available
Oulu, 90220
FinlandSite Not Available
Tampere, 33521
FinlandSite Not Available
Turku, 20520
FinlandSite Not Available
Angers Cedex, 49055
FranceSite Not Available
Besancon, 25030
FranceSite Not Available
Bordeaux Cedex, 33076
FranceSite Not Available
Brest, 29200
FranceSite Not Available
empty
Caen Cedex 5, 14076
FranceSite Not Available
Cergy Pontoise, 95303
FranceSite Not Available
Clermont-ferrand, 63011
FranceSite Not Available
Creteil, 94010
FranceSite Not Available
empty
Dijon, 21000
FranceSite Not Available
Marseille, 13273
FranceSite Not Available
Montpellier Cedex, 34298
FranceSite Not Available
Nancy, 54100
FranceSite Not Available
empty
PARIS cedex 5, 75248
FranceSite Not Available
empty
Paris, 75674
FranceSite Not Available
Pierre Benite, 69495
FranceSite Not Available
Poitiers, 86021
FranceSite Not Available
empty
Pontoise, 95301
FranceSite Not Available
empty
REIMS cedex, 51726
FranceSite Not Available
Reims, 51726
FranceSite Not Available
Saint Herblain Cedex, 44805
FranceSite Not Available
empty
Saint Mande, 94160
FranceSite Not Available
Saint-gregoire, 35760
FranceSite Not Available
Strasbourg, 67033
FranceSite Not Available
Villejuif Cedex, 94805
FranceSite Not Available
Freiburg, Baden-Württemberg 79106
GermanySite Not Available
Nürtingen, Baden-Württemberg 72622
GermanySite Not Available
empty
Reutlingen, Baden-Württemberg 72766
GermanySite Not Available
Tübingen, Baden-Württemberg 72076
GermanySite Not Available
Ulm, Baden-Württemberg 89075
GermanySite Not Available
Erlangen, Bayern 91054
GermanySite Not Available
Rostock, Mecklenburg-Vorpommern 18107
GermanySite Not Available
Braunschweig, Niedersachsen 38126
GermanySite Not Available
empty
Düsseldorf, Nordrhein-Westfalen 40225
GermanySite Not Available
empty
Köln, Nordrhein-Westfalen 50931
GermanySite Not Available
Münster, Nordrhein-Westfalen 48149
GermanySite Not Available
empty
Homburg, Saarland 66421
GermanySite Not Available
empty
Dresden, Sachsen 01307
GermanySite Not Available
Magdeburg, Sachsen-Anhalt 39120
GermanySite Not Available
Jena, Thüringen 07747
GermanySite Not Available
Berlin, 12203
GermanySite Not Available
Beer Sheva, 8410101
IsraelSite Not Available
Haifa, 3109601
IsraelSite Not Available
Holon, 5822012
IsraelSite Not Available
Jerusalem, 9112001
IsraelSite Not Available
Petach Tikva, 4941492
IsraelSite Not Available
empty
Petah Tikva, 4941492
IsraelSite Not Available
Tel Aviv, 6423906
IsraelSite Not Available
Zefat, 1311001
IsraelSite Not Available
empty
Zerifin, 6093000
IsraelSite Not Available
Zrifin, 7030000
IsraelSite Not Available
Bologna, Emilia-Romagna 40138
ItalySite Not Available
Parma, Emilia-Romagna 43126
ItalySite Not Available
Roma, Lazio 00152
ItalySite Not Available
Milano, Lombardia 20141
ItalySite Not Available
Novara, Piemonte 28100
ItalySite Not Available
Torino, Piemonte 10043
ItalySite Not Available
empty
Bari, Puglia 70124
ItalySite Not Available
empty
Orbassano, Torino 10043
ItalySite Not Available
empty
Arezzo, Toscana 52100
ItalySite Not Available
Trento, Trentino-Alto Adige 38100
ItalySite Not Available
Padova, Veneto 35128
ItalySite Not Available
Verona, Veneto 37134
ItalySite Not Available
Nagoya, Aichi 466-8560
JapanSite Not Available
Hirosaki, Aomori 036-8563
JapanSite Not Available
Asahi, Chiba 289-2511
JapanSite Not Available
Kashiwa, Chiba 277-8577
JapanSite Not Available
Sakura, Chiba 285-8741
JapanSite Not Available
Matsuyama, Ehime 791-0280
JapanSite Not Available
Sapporo, Hokkaido 003-0804
JapanSite Not Available
Kobe, Hyogo 650-0017
JapanSite Not Available
Kanazawa, Ishikawa 920-8641
JapanSite Not Available
Kita, Kagawa 761-0793
JapanSite Not Available
Yokohama, Kanagawa 241-8515
JapanSite Not Available
Tsu, Mie 514-8507
JapanSite Not Available
Sendai, Miyagi 980-8574
JapanSite Not Available
Kashihara, Nara 634-8522
JapanSite Not Available
empty
Higashiosaka, Osaka 578-8588
JapanSite Not Available
Osakasayama, Osaka 589-8511
JapanSite Not Available
Suita, Osaka 565-0871
JapanSite Not Available
Hamamatsu, Shizuoka 431-3192
JapanSite Not Available
Shimotsuke, Tochigi 329-0498
JapanSite Not Available
Utsunomiya, Tochigi 321-0974
JapanSite Not Available
Bunkyo-ku, Tokyo 113-8603
JapanSite Not Available
Koto-ku, Tokyo 135-8550
JapanSite Not Available
Meguro-ku, Tokyo 152-8902
JapanSite Not Available
Minato-ku, Tokyo 105-8471
JapanSite Not Available
Mitaka, Tokyo 181-8611
JapanSite Not Available
Nakano-ku, Tokyo 164-8541
JapanSite Not Available
Shinjuku-ku, Tokyo 160-8582
JapanSite Not Available
Yonago, Tottori 683-8504
JapanSite Not Available
Ube, Yamaguchi 755-8505
JapanSite Not Available
Chiba, 260-8677
JapanSite Not Available
Fukuoka, 811-1395
JapanSite Not Available
Gifu, 500-8717
JapanSite Not Available
Kumamoto, 860-0008
JapanSite Not Available
Miyazaki, 889-1692
JapanSite Not Available
Nagasaki, 852-8501
JapanSite Not Available
Okayama, 700-8558
JapanSite Not Available
Osaka, 545-8586
JapanSite Not Available
Tokushima, 770-8503
JapanSite Not Available
empty
Toyama, 930-0194
JapanSite Not Available
Wakayama, 641-8510
JapanSite Not Available
empty
Donggu,, Gwangju Gwang''yeogsi 501-757
Korea, Republic ofSite Not Available
Gwangju, Gwangju Gwang''yeogsi 61469
Korea, Republic ofSite Not Available
Seongnam-si, Gyeonggido 13620
Korea, Republic ofSite Not Available
Busan, 47392
Korea, Republic ofSite Not Available
Daegu, 700721
Korea, Republic ofSite Not Available
Gyeonggi-do, 11923
Korea, Republic ofSite Not Available
Seoul, 06591
Korea, Republic ofSite Not Available
Ciudad de Mexico, Distrito Federal 06760
MexicoSite Not Available
empty
Mexico, Distrito Federal 14080
MexicoSite Not Available
empty
Mexico, D.F., Distrito Federal CP 14050
MexicoSite Not Available
empty
México, Distrito Federal 14080
MexicoSite Not Available
México, D. F., Distrito Federal 06760
MexicoSite Not Available
Cuernavaca, Morelos 62290
MexicoSite Not Available
empty
Cuatlitlan Izcalli, México 54769
MexicoSite Not Available
Monterrey, Nuevo Leon 64460
MexicoSite Not Available
Santiago de Querétaro, Querétaro 76000
MexicoSite Not Available
Mazatlán, Sinaloa 82110
MexicoSite Not Available
empty
Mérida, Yucatán 97130
MexicoSite Not Available
empty
Cuautitlan Izcalli, 54769
MexicoSite Not Available
empty
Durango, 34000
MexicoSite Not Available
empty
Querétaro, 76000
MexicoSite Not Available
Amsterdam, 1081 HV
NetherlandsSite Not Available
Den Haag, 2545 AA
NetherlandsSite Not Available
Dordrecht, 3318 AT
NetherlandsSite Not Available
Geleen, 6162 BG
NetherlandsSite Not Available
empty
Heerlen, 6401 CX
NetherlandsSite Not Available
Hilversum, 1213 XZ
NetherlandsSite Not Available
Hoofddorp, 2134 TM
NetherlandsSite Not Available
empty
Nijmegen, 6525 GA
NetherlandsSite Not Available
Tilburg, 5042 AD
NetherlandsSite Not Available
empty
Bydgoszcz, 85-165
PolandSite Not Available
Lodz, 90-302
PolandSite Not Available
Lublin, 20-362
PolandSite Not Available
empty
Poznan, 60-569
PolandSite Not Available
Rybnik, 44-200
PolandSite Not Available
Siedlce, 08-110
PolandSite Not Available
Waliszew, 05-135
PolandSite Not Available
Warszawa, 02-781
PolandSite Not Available
empty
Wroclaw, 50 - 556
PolandSite Not Available
Barnaul, 656045
Russian FederationSite Not Available
Chelyabinsk, 454048
Russian FederationSite Not Available
Moscow, 125284
Russian FederationSite Not Available
Novosibirsk, 630099
Russian FederationSite Not Available
Omsk, 644013
Russian FederationSite Not Available
St. Petersburg, 194017
Russian FederationSite Not Available
Sabadell, Barcelona 08208
SpainSite Not Available
Palma De Mallorca, Illes Baleares 7120
SpainSite Not Available
Malaga, Málaga 29010
SpainSite Not Available
Barcelona, 08003
SpainSite Not Available
empty
Caceres, 10003
SpainSite Not Available
Cáceres, 10003
SpainSite Not Available
Córdoba, 14004
SpainSite Not Available
Lugo, 27003
SpainSite Not Available
Madrid, 28041
SpainSite Not Available
empty
Málaga, 29010
SpainSite Not Available
Málaga, 29010
SpainSite Not Available
Valencia, 46009
SpainSite Not Available
Göteborg, 413 45
SwedenSite Not Available
Lund, 221 85
SwedenSite Not Available
empty
Solna, 171 64
SwedenSite Not Available
Solna, 171 64
SwedenSite Not Available
empty
Stockholm, 171 76
SwedenSite Not Available
Stockholm, 17176
SwedenSite Not Available
Umea, 901 85
SwedenSite Not Available
empty
Umeå, 901 85
SwedenSite Not Available
Umeå, 901 85
SwedenSite Not Available
Uppsala, 751 85
SwedenSite Not Available
empty
Genève, 1205
SwitzerlandSite Not Available
Kaohsiung City, Kaohsiung 807377
TaiwanSite Not Available
empty
Kaohsiung, 807
TaiwanSite Not Available
Kaohsiung, 807
TaiwanSite Not Available
Taichung, 40447
TaiwanSite Not Available
Taipei, 11217
TaiwanSite Not Available
Taoyuan, 33305
TaiwanSite Not Available
Colchester, Essex CO45JR
United KingdomSite Not Available
Romford, Essex RM7 0AG
United KingdomSite Not Available
Middlesborough, North Yorkshire TS43BW
United KingdomSite Not Available
empty
Middlesbrough, North Yorkshire TS4 3BW
United KingdomSite Not Available
empty
Oxford, Oxfordshire OX3 7LJ
United KingdomSite Not Available
Belfast, BT9 7AB
United KingdomSite Not Available
Glasgow, G12 0YN
United KingdomSite Not Available
London, NW1 2BU
United KingdomSite Not Available
Chandler, Arizona 85224
United StatesSite Not Available
empty
Gilbert, Arizona 85234
United StatesSite Not Available
empty
Scottsdale, Arizona 85259-5452
United StatesSite Not Available
Tucson, Arizona 85724
United StatesSite Not Available
Beverly Hills, California 90211-1850
United StatesSite Not Available
Duarte, California 91010
United StatesSite Not Available
Los Angeles, California 90073-1003
United StatesSite Not Available
Stanford, California 94305-5820
United StatesSite Not Available
empty
Aurora, Colorado 80045
United StatesSite Not Available
empty
Denver, Colorado 80211
United StatesSite Not Available
empty
New Haven, Connecticut 06520
United StatesSite Not Available
Washington, District of Columbia 20007-2113
United StatesSite Not Available
empty
Washington, D.C., District of Columbia 20007-2197
United StatesSite Not Available
Boca Raton, Florida 33486
United StatesSite Not Available
Gainesville, Florida 32610-0316
United StatesSite Not Available
empty
Miami Beach, Florida 33140
United StatesSite Not Available
Tampa, Florida 33612-9416
United StatesSite Not Available
Atlanta, Georgia 30322
United StatesSite Not Available
empty
Newnan, Georgia 30265
United StatesSite Not Available
Chicago, Illinois 60611
United StatesSite Not Available
Peoria, Illinois 61615-7828
United StatesSite Not Available
Louisville, Kentucky 40202
United StatesSite Not Available
New Orleans, Louisiana 70112
United StatesSite Not Available
Baltimore, Maryland 21231
United StatesSite Not Available
Towson, Maryland 21204
United StatesSite Not Available
Boston, Massachusetts 02111
United StatesSite Not Available
empty
Burlington, Massachusetts 01805
United StatesSite Not Available
Detroit, Michigan 48202
United StatesSite Not Available
Billings, Montana 59102
United StatesSite Not Available
Omaha, Nebraska 68130-5606
United StatesSite Not Available
Lebanon, New Hampshire 03756
United StatesSite Not Available
Camden, New Jersey 08143
United StatesSite Not Available
Englewood, New Jersey 07361
United StatesSite Not Available
Hackensack, New Jersey 07601
United StatesSite Not Available
empty
Voorhee, New Jersey 08043
United StatesSite Not Available
empty
Voorhees, New Jersey 08043
United StatesSite Not Available
Albuquerque, New Mexico 87109
United StatesSite Not Available
Bronx, New York 10467-2490
United StatesSite Not Available
Buffalo, New York 14203
United StatesSite Not Available
empty
New Hyde Park, New York 11042
United StatesSite Not Available
New York, New York 10032
United StatesSite Not Available
Poughkeepsie, New York 12601
United StatesSite Not Available
Rochester, New York 14642
United StatesSite Not Available
empty
Syracuse, New York 13210
United StatesSite Not Available
empty
Concord, North Carolina 28025
United StatesSite Not Available
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Cleveland, Ohio 44106
United StatesSite Not Available
Columbus, Ohio 43210
United StatesSite Not Available
Kettering, Ohio 45409-1328
United StatesSite Not Available
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
empty
Bend, Oregon 97701-6015
United StatesSite Not Available
empty
Bala Cynwyd, Pennsylvania 19004
United StatesSite Not Available
Bala-Cynwyd, Pennsylvania 19004
United StatesSite Not Available
Camp Hill, Pennsylvania 17011
United StatesSite Not Available
empty
Ephrata, Pennsylvania 17522-1761
United StatesSite Not Available
empty
Hershey, Pennsylvania 17033
United StatesSite Not Available
empty
Philadelphia, Pennsylvania 19111-2497
United StatesSite Not Available
Pittsburgh, Pennsylvania 15212
United StatesSite Not Available
empty
Providence, Rhode Island 02906
United StatesSite Not Available
Charleston, South Carolina 29414
United StatesSite Not Available
Greenville, South Carolina 29607
United StatesSite Not Available
Myrtle Beach, South Carolina 29572
United StatesSite Not Available
North Charleston, South Carolina 29406
United StatesSite Not Available
empty
Nashville, Tennessee 37232-0021
United StatesSite Not Available
Dallas, Texas 75231
United StatesSite Not Available
empty
Houston, Texas 77030
United StatesSite Not Available
Temple, Texas 76508
United StatesSite Not Available
Salt Lake City, Utah 84112
United StatesSite Not Available
Charlottesville, Virginia 22908
United StatesSite Not Available
Fairfax, Virginia 22031
United StatesSite Not Available
Richmond, Virginia 23298-5054
United StatesSite Not Available
Everett, Washington 98201
United StatesSite Not Available
empty
Seattle, Washington 98109-1023
United StatesSite Not Available
empty
Spokane, Washington 99208-1129
United StatesSite Not Available
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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