A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Start Date
12/22/2016
Completion Date
7/31/2029
Summary
The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.
Detailed Description
Subjects must continue on the treatment regimen that the subject was receiving in the prior study. Dose changes of any of the prior therapies subjects were receiving on the previous protocol are allowed after medical monitor approval. The day 1 visit for this study should coincide with the last treatment visit for the study the subject will be enrolling from (≤ 7 days post last visit of parent study) unless the subject is on treatment suspension. The subjects will be followed according to the local institution's standard of care and will be required to return to the institution every 24 weeks (± 7 days) to review adverse events (AEs), collect concomitant medications and confirm that no discontinuation criteria are met. At each visit and at every 12 weeks (IP only visit) subjects are to return all dispensed study drug and to receive more study drug if applicable. All AEs (new and ongoing from the study the subject is enrolling from) and Serious Adverse Events (SAEs) (including death), will be collected from the time the subject signs the consent form until the end of study visit. After the marketing approval in South Korea, this study continued as "post marketing clinical study" in South Korea. In the rest of the countries which participated in this study, this study continued as clinical study.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
enzalutamide
abiraterone acetate
prednisone
Leuprolide acetate
Conditions
Locations
Site US10052
Anchorage, Alaska 99503
United States
Site US10011
Tucson, Arizona 85741
United States
Site US10040
Los Angeles, California 90024
United States
Site US10009
Los Angeles, California 90048
United States
Site US10067
Orange, California 92868
United States
Site US10008
San Bernardino, California 92404
United States
Site US10042
San Diego, California 92108
United States
Site US10028
Stanford, California 94305
United States
Site US10001
Aurora, Colorado 80045
United States
Site US10017
Denver, Colorado 80211
United States
Site US10050
Washington D.C., District of Columbia 20037
United States
Site US10049
Daytona Beach, Florida 32114
United States
Site US10048
Jacksonville, Florida 32216
United States
Site US10002
Chicago, Illinois 60637
United States
Springfield Clinic, LLP
Springfield, Illinois 62701
United States
Site US10007
Jeffersonville, Indiana 47130
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Site US10066
Lenexa, Kansas 66214-1656
United States
Site US10029
Towson, Maryland 21204
United States
Site US10032
St Louis, Missouri 63110
United States
Nebraska Medical Hospital
Omaha, Nebraska 68114
United States
Site US10023
Omaha, Nebraska 68130
United States
Site US10004
Hackensack, New Jersey 07601
United States
Site US10024
Garden City, New York 11530
United States
Site US10055
New York, New York 10065
United States
Site US10059
New York, New York 10065
United States
Hudson Valley Urology, PC
Poughkeepsie, New York 12601
United States
Site US10053
Syracuse, New York 13210
United States
Site US10030
Chapel Hill, North Carolina 27599
United States
Site US10062
Charlotte, North Carolina 28207
United States
Site US10020
Concord, North Carolina 28025
United States
Site US10031
Greensboro, North Carolina 27403
United States
Eastern Urological Associates
Greenville, North Carolina 27834
United States
Site US10046
Winston-Salem, North Carolina 27157
United States
Site US10035
Cincinnati, Ohio 45212
United States
Site US10022
Springfield, Oregon 97477
United States
Site US10027
Lancaster, Pennsylvania 17604
United States
Site US10005
Pittsburgh, Pennsylvania 15232
United States
Site US10018
Charleston, South Carolina 29414
United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Site US10003
Myrtle Beach, South Carolina 29572
United States
Site US10041
Nashville, Tennessee 37232-2765
United States
Site US10010
Dallas, Texas 75231
United States
Site US10034
Houston, Texas 77024
United States
Site US10043
Houston, Texas 77030
United States
Site US10014
Norfolk, Virginia 23502
United States
Site US10015
Virginia Beach, Virginia 23462
United States
Virginia Mason Medical Center
Seattle, Washington 98101
United States
Site US10038
Seattle, Washington 98109
United States
Site US10021
Madison, Wisconsin 53792
United States
Site AR54005
Buenos Aires, Buenos Aires F.D. C1120AAT
Argentina
Site AR54007
Rosario, Santa Fe Province S2000DSV
Argentina
Site AR54008
Buenos Aires,
Argentina
Site AR54003
Cordorba,
Argentina
Site AR54006
San Miguel de Tucumán, T4000IAK
Argentina
Site AR54002
San Miguel de Tucumán,
Argentina
Site AU61014
Albury, New South Wales 2640
Australia
Site AU61001
Tweed Heads, New South Wales 2485
Australia
Site AU61012
Wahroonga, New South Wales 2076
Australia
Site AU61017
Wahroonga, New South Wales 2076
Australia
Site AU61006
Ashford,
Australia
Site AU61019
Ballarat, 3350
Australia
Site AU61007
East Bentleigh, 3165
Australia
Site AU61009
Malvern,
Australia
Site AU61021
Parkville,
Australia
Site AU61008
South Brisbane,
Australia
Site AU61016
St Albans, 3021
Australia
Site AU61004
Westmead, 2145
Australia
Site AT43001
Vienna, 1090
Austria
Site BE32002
Kortrijk, West-Vlaanderen 8500
Belgium
Site BE32009
Anderlecht, 1070
Belgium
Site BE32004
Brussels, B-1090
Belgium
Site BE32005
Ghent, 9000
Belgium
Site BE32011
Ghent, 9000
Belgium
Site BE32007
Hasselt,
Belgium
Site BE32008
Leuven, 3000
Belgium
Site BE32001
Liège, 4000
Belgium
Site BE32003
Turnhout, 2300
Belgium
Site BR55007
Porto Alegre, Rio Grande do Sul 90430-090
Brazil
Site BR55009
Bahia, 41253-190
Brazil
Site BR55008
Campinas,
Brazil
Site BR55004
Ijuí, 98700-000
Brazil
Site BR55011
Jaú,
Brazil
Site BR55002
Rio Grande, 90610-000
Brazil
Site BR55010
Santo André, 09060-650
Brazil
Site CA15003
Kingston, Ontario K7L 3J7
Canada
Site CA15021
Toronto, Ontario M4N 3M5
Canada
Site CA15001
Granby, Quebec J2G 8Z9
Canada
Site CA15019
Abbotsford British Columbia, V2S 3N5
Canada
Site CA15020
Greenville, L6R 3J7 27834
Canada
Site CA15011
Montreal,
Canada
Site CA15017
Oakville, L6H 3P1
Canada
Site CA15022
Québec, QC / G1S 4L8
Canada
Site CL56007
Santiago, RM 7500787
Chile
Site CL56005
Santiago, RM 75009
Chile
Site CL56006
Viña del Mar, Valparaiso 2520598
Chile
Site CL56004
IX Region,
Chile
Site CL56002
Santiago,
Chile
Site CL56001
Viña del Mar,
Chile
Site CN86003
Hubei, 430030
China
Site CN86010
Hunan, 410013
China
Site CN86005
Nanjing,
China
Site CZ42004
Olomouc, 775 20
Czechia
Site CZ42002
Olomouc, 779 00
Czechia
Site CZ42001
Prague, 16000
Czechia
Site CZ42003
Prague,
Czechia
Site DK45002
Aalborg, North Denmark 9000
Denmark
Site DK45003
Aarhus, 8200
Denmark
Site DK45001
Copenhagen, 2100
Denmark
Site DK45004
Herlev, 2730
Denmark
Site DK45006
Vejle, 7100
Denmark
Site FL35802
Tampere,
Finland
Site FL35805
Turku, 20521
Finland
Site FR33021
Bordeaux, 33076
France
Site FR33008
La Roche-sur-Yon, 85925
France
Site FR33010
Lille, 59037
France
Site FR33002
Lyon, 69003
France
Site FR33020
Montpellier, 34298
France
Site FR33006
Nîmes, 30029
France
Site FR33003
Paris,
France
Site FR33017
Paris,
France
Site FR33001
Saint-Herblain,
France
Site FR33019
Strasbourg, 67000
France
Site FR33022
Strasbourg, 67098
France
Site FR33004
Villejuif,
France
Site GE99501
Tbilisi, GE- 0186
Georgia
Site DE49004
Nürtingen, Baden-Wurttemberg 72622
Germany
Site DE49007
Waldshut-Tiengen, Baden-Wurttemberg 79761
Germany
Site DE49006
Mannheim, DE 68167
Germany
Site DE49001
Duisburg, North Rhine-Westphalia 47179
Germany
Site DE49010
Bonn, 53111
Germany
Site DE49003
Hamburg, 22081
Germany
Site DE49013
Hamburg,
Germany
Site HK85202
Hong Kong,
Hong Kong
Site IL97206
Haifa, 3109601
Israel
Site IL97205
Jerusalem,
Israel
Site IL97202
Peth Tikva,
Israel
Site IL97204
Ramat Gan,
Israel
Site IL97203
Tzrifin Beer Yakov,
Israel
Site IT39008
Faenza (RA), Emilia-Romagna 48018
Italy
Site IT39001
Arezzo,
Italy
Site IT39011
Candiolo,
Italy
Site IT39004
Cremona,
Italy
Site IT39002
Forlì,
Italy
Site IT39005
Roma,
Italy
Site IT39009
Toscana,
Italy
Site IT39006
Trento, 38122
Italy
Toho University Sakura Medical Center
Sakura-shi, Chiba
Japan
Kyushu University Hospital
Higashiku, Fukuoka
Japan
Gunma University Hospital
Maebashi, Gunma
Japan
Kagawa University Hospital
Kida-gun, Kagawa-ken
Japan
Yokohama City University Medical Center
Yokohama, Kanagawa 232-0024
Japan
Kindai University Hospital
Sayama, Osaka 589-8511
Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo
Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koutou-ku, Tokyo
Japan
Yamaguchi University Hospital
Ube, Yamaguchi
Japan
Chiba cancer center
Chiba, 260-8717
Japan
Harasanshin hospital
Fukuoka, 812-0033
Japan
Kyoto University hospital
Kyoto, 606-8507
Japan
Niigata University Medical and Dental Hospital
Niigata, 951-8520
Japan
Osaka Metropolitan University Hospital
Osaka,
Japan
Site MY60001
Kuching, 93586
Malaysia
Site MD37301
Chisinau,
Moldova
Site NL31010
Amsterdam, 1066 CX
Netherlands
Site NL31009
Den Helder,
Netherlands
Site NL31004
Maastricht, 6229
Netherlands
Site NL31011
Rotterdam, 3045 PM
Netherlands
Site NZ64002
Auckland, V2S 3N5
New Zealand
Site NZ64005
Dunedin, 9016
New Zealand
Site NZ64001
Hamilton,
New Zealand
Site NO47001
Stavanger,
Norway
Site PL48002
Gdansk,
Poland
Site PL48001
Mysłowice,
Poland
Site PL48004
Pozman,
Poland
Site PL48005
Słupsk, 76-200
Poland
Site PL48011
Warsaw, 04-073
Poland
Site PL48003
Wroclaw, 54-144
Poland
Site RO40003
Bucharest, 50659
Romania
Site RO40001
Cluj-Napoca, 400015
Romania
Site RO40004
Cluj-Napoca, 400015
Romania
Site RU70008
Ivanovo, 153040
Russia
Site RU70001
Moscow, 125284
Russia
Site RU70005
Omsk,
Russia
Site RU70009
Saint Petersburg, 191104
Russia
Site RU70003
Saint Petersburg,
Russia
Site RU70006
Saint Petersburg,
Russia
Site RS38102
Belgrade, 11040
Serbia
Site RS38101
Belgrade, 11080
Serbia
Site SK10223
Bratislava,
Slovakia
Site SK42109
Košice, 04001
Slovakia
Site SK42106
Košice, 04191
Slovakia
Site SK42105
Nitra, 949 01
Slovakia
Site SK42103
Prešov, 080 01
Slovakia
Site SK42108
Trenčín, 91101
Slovakia
Site SK42107
Žilina,
Slovakia
Site ZA27001
George, 6529
South Africa
Site KR82008
Busan, 49241
South Korea
Site KR82012
Seongnam-si, 013620
South Korea
Site KR82005
Seongnam-si,
South Korea
Site KR82009
Seoul, 03080
South Korea
Site KR82007
Seoul, 06351
South Korea
Site KR82011
Seoul, 138-736
South Korea
Site KR82001
Seoul,
South Korea
Site KR82002
Seoul,
South Korea
Site KR82003
Seoul,
South Korea
Site KR82004
Seoul,
South Korea
Site ES34007
Barcelona, 08036
Spain
Site ES34003
Barcelona,
Spain
Site ES34004
Barcelona,
Spain
Site ES34011
Girona, 17007
Spain
Site ES34012
Madrid, 28006
Spain
Site ES34001
Madrid, 28034
Spain
Site ES34008
Madrid,
Spain
Site ES34005
Pamplona,
Spain
Site ES34014
Salamanca,
Spain
Site ES34010
Santiago de Compostela, 15706
Spain
Site SE46001
Gothenburg, 41345
Sweden
Site SE46003
Umeå, 90185
Sweden
Site TW88607
Guishan, 33305
Taiwan
Site TW88603
Kaohsiung City, 81362
Taiwan
Site TW88601
Kaohsiung City,
Taiwan
Site TW88602
Taichung, 40447
Taiwan
Site TW88606
Taipei, 10002
Taiwan
Site TH66001
Hat Yai, Changwat Songkhla 90110
Thailand
Site TH66002
Bangkok, 10330
Thailand
Site TR90002
Beşevler, Ankara 06500
Turkey (Türkiye)
Site UA38004
Dnipro, 49005
Ukraine
Site UA38005
Kharkiv, 61037
Ukraine
Site UA38001
Kyiv, 02125
Ukraine
Site UA38003
Uzhhorod, 88000
Ukraine
Site GB44009
Bebington,
United Kingdom
Site GB44003
Belfast,
United Kingdom
Site GB44004
Bristol, BS28HW
United Kingdom
Site GB44014
Cambridge,
United Kingdom
Site GB44005
Cardiff, CF4 4XN
United Kingdom
Site GB44002
Glasgow,
United Kingdom
Site GB44006
London,
United Kingdom
Site GB44007
Manchester, M20 4BX
United Kingdom
Site GB44008
Northwood,
United Kingdom
Site GB44016
Nottingham, NG5 1PB
United Kingdom
Site GB44001
Sutton,
United Kingdom