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Spots Global Cancer Trial Database for A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

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Trial Identification

Brief Title: A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Official Title: A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Study ID: NCT02960022

Conditions

Prostate Cancer

Study Description

Brief 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). 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Site US10052, Anchorage, Alaska, United States

Site US10011, Tucson, Arizona, United States

Site US10040, Los Angeles, California, United States

Site US10009, Los Angeles, California, United States

Site US10067, Orange, California, United States

Site US10008, San Bernardino, California, United States

Site US10042, San Diego, California, United States

Site US10028, Stanford, California, United States

Site US10001, Aurora, Colorado, United States

Site US10017, Denver, Colorado, United States

Site US10050, Washington, District of Columbia, United States

Site US10049, Daytona Beach, Florida, United States

Site US10048, Jacksonville, Florida, United States

Site US10002, Chicago, Illinois, United States

Springfield Clinic, LLP, Springfield, Illinois, United States

Site US10007, Jeffersonville, Indiana, United States

University of Kansas Medical Center, Kansas City, Kansas, United States

Site US10066, Lenexa, Kansas, United States

Site US10029, Towson, Maryland, United States

Site US10032, Saint Louis, Missouri, United States

Nebraska Medical Hospital, Omaha, Nebraska, United States

Site US10023, Omaha, Nebraska, United States

Site US10004, Hackensack, New Jersey, United States

Site US10024, Garden City, New York, United States

Site US10055, New York, New York, United States

Site US10059, New York, New York, United States

Hudson Valley Urology, PC, Poughkeepsie, New York, United States

Site US10053, Syracuse, New York, United States

Site US10030, Chapel Hill, North Carolina, United States

Site US10062, Charlotte, North Carolina, United States

Site US10020, Concord, North Carolina, United States

Site US10031, Greensboro, North Carolina, United States

Eastern Urological Associates, Greenville, North Carolina, United States

Site US10046, Winston-Salem, North Carolina, United States

Site US10035, Cincinnati, Ohio, United States

Site US10022, Springfield, Oregon, United States

Site US10027, Lancaster, Pennsylvania, United States

Site US10005, Pittsburgh, Pennsylvania, United States

Site US10018, Charleston, South Carolina, United States

Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States

Site US10003, Myrtle Beach, South Carolina, United States

Site US10041, Nashville, Tennessee, United States

Site US10010, Dallas, Texas, United States

Site US10034, Houston, Texas, United States

Site US10043, Houston, Texas, United States

Site US10014, Norfolk, Virginia, United States

Site US10015, Virginia Beach, Virginia, United States

Virginia Mason Medical Center, Seattle, Washington, United States

Site US10038, Seattle, Washington, United States

Site US10021, Madison, Wisconsin, United States

Site AR54005, Buenos Aires, Caba, Argentina

Site AR54007, Rosario, Santa Fé, Argentina

Site AR54003, Cordorba, , Argentina

Site AR54006, San Miguel de Tucuman, , Argentina

Site AR54002, Tucuman, , Argentina

Site AU61014, Albury, New South Wales, Australia

Site AU61001, Tweed Heads, New South Wales, Australia

Site AU61017, Wahroonga, New South Wales, Australia

Site AU61006, Ashford, , Australia

Site AU61019, Ballarat, , Australia

Site AU61007, East Bentleigh, , Australia

Site AU61009, Malvern, , Australia

Site AU61021, Parkville, , Australia

Site AU61008, South Brisbane, , Australia

Site AU61016, St Albans, , Australia

Site AU61004, Westmead, , Australia

Site AU61004, Westmead, , Australia

Site AT43001, Vienna, , Austria

Site BE32002, Kortrijk, West-Vlaanderen, Belgium

Site BE32009, Anderlecht, , Belgium

Site BE32004, Brussels, , Belgium

Site BE32005, Gent, , Belgium

Site BE32011, Gent, , Belgium

Site BE32007, Hasselt, , Belgium

Site BE32008, Leuven, , Belgium

Site BE32001, Liege, , Belgium

Site BE32003, Turnhout, , Belgium

Site BR55007, Porto Alegre, RIO Grande DO SUL, Brazil

Site BR55009, Bahia, , Brazil

Site BR55008, Campinas, , Brazil

Site BR55004, Ijuí, , Brazil

Site BR55011, Jau, , Brazil

Site BR55002, Rio Grande Do Sul, , Brazil

Site BR55010, Santo Andre, , Brazil

Site CA15003, Kingston, Ontario, Canada

Site CA15021, Toronto, Ontario, Canada

Site CA15001, Granby, Quebec, Canada

Site CA15019, Abbotsford, , Canada

Site CA15020, Greenville, , Canada

Site CA15011, Montreal, , Canada

Site CA15017, Oakville, , Canada

Site CA15022, Quebec, , Canada

Site CL56007, Santiago, RM, Chile

Site CL56005, Santiago, RM, Chile

Site CL56006, Vina Del Mar, Valparaiso, Chile

Site CL56004, IX Region, , Chile

Site CL56002, Santiago, , Chile

Site CL56001, Vina del Mar, , Chile

Site CZ42004, Olomouc, , Czechia

Site CZ42002, Olomouc, , Czechia

Site CZ42003, Praha 2, , Czechia

Site CZ42001, Praha 6, , Czechia

Site DK45002, Aalborg, Nordjylland, Denmark

Site DK45003, Aarhus, , Denmark

Site DK45001, Copenhagen, , Denmark

Site DK45004, Herlev, , Denmark

Site DK45006, Vejle, , Denmark

Site FL35802, Tampere, , Finland

Site FL35805, Turku, , Finland

Site FR33008, La Roche sur Yon, , France

Site FR33010, Lille, , France

Site FR33002, Lyon Cedex 3, , France

Site FR33020, Montpellier Cedex, , France

Site FR33006, Nimes, , France

Site FR33003, Paris, , France

Site FR33017, Paris, , France

Site FR33001, Saint Herblain, , France

Site FR33019, Strasbourg, , France

Site FR33022, Strasbourg, , France

Site FR33004, Villejuif, , France

Site GE99501, Tbilisi, , Georgia

Site DE49004, Nürtingen, Baden-Württemberg, Germany

Site DE49007, Waldshut-Tiengen, Baden-Württemberg, Germany

Site DE49006, Mannheim, DE, Germany

Site DE49001, Duisburg, NRW, Germany

Site DE49010, Bonn, , Germany

Site DE49003, Hamburg, , Germany

Site DE49013, Hamburg, , Germany

Site HK85202, Hong Kong, , Hong Kong

Site IL97202, Peth Tikva, , Israel

Site IL97204, Ramat-Gan, , Israel

Site IL97203, Tzrifin Beer Yakov, , Israel

Site IT39008, Faenza (RA), Emilia Romagna, Italy

Site IT39001, Arezzo, , Italy

Site IT39011, Candiolo, , Italy

Site IT39004, Cremona, , Italy

Site IT39002, Forli, , Italy

Site IT39005, Roma, , Italy

Site IT39006, Trento, , Italy

Toho University Sakura Medical Center, Sakura-shi, Chiba, Japan

Kyushu University Hospital, Higashi-ku, Fukuoka, Japan

Gunma University Hospital, Maebashi-shi, Gunma, Japan

Kagawa University Hospital, Kida-gun, Kagawa, Japan

Yokohama City University Medical Center, Yokohama, Kanagawa, Japan

Kindai University Hospital, Sayama, Osaka, 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, , Japan

Harasanshin hospital, Fukuoka, , Japan

Kyoto University hospital, Kyoto, , Japan

Niigata University Medical and Dental Hospital, Niigata, , Japan

Osaka Metropolitan University Hospital, Osaka, , Japan

Site KR82008, Busan, , Korea, Republic of

Site KR82012, Seongnam-si, , Korea, Republic of

Site KR82005, Seongnam-si, , Korea, Republic of

Site KR82009, Seoul, , Korea, Republic of

Site KR82007, Seoul, , Korea, Republic of

Site KR82011, Seoul, , Korea, Republic of

Site KR82001, Seoul, , Korea, Republic of

Site KR82002, Seoul, , Korea, Republic of

Site KR82003, Seoul, , Korea, Republic of

Site KR82004, Seoul, , Korea, Republic of

Site MY60001, Kuching, , Malaysia

Site MD37301, Chisinau, , Moldova, Republic of

Site NL31009, Den Helder, , Netherlands

Site NL31004, Maastricht, , Netherlands

Site NL31011, Rotterdam, , Netherlands

Site NZ64002, Auckland, , New Zealand

Site NZ64005, Dunedin, , New Zealand

Site NZ64001, Hamilton, , New Zealand

Site NO47001, Stavanger, , Norway

Site PL48002, Gdansk, , Poland

Site PL48001, Myslowice, , Poland

Site PL48004, Pozman, , Poland

Site PL48005, Slupsk, , Poland

Site PL48003, Wrocław, , Poland

Site RO40003, Bucuresti, , Romania

Site RU70001, Moscow, , Russian Federation

Site RU70001, Moscow, , Russian Federation

Site RU70003, St. Petersburg, , Russian Federation

Site RS38102, Belgrade, , Serbia

Site RS38101, Belgrade, , Serbia

Site SK10223, Bratislava, , Slovakia

Site SK42109, Kosice, , Slovakia

Site SK42106, Kosice, , Slovakia

Site SK42105, Nitra, , Slovakia

Site SK42103, Presov, , Slovakia

Site SK42108, Trencin, , Slovakia

Site SK42107, Zilina, , Slovakia

Site ZA27001, George, , South Africa

Site ES34007, Barcelona, , Spain

Site ES34003, Barcelona, , Spain

Site ES34004, Barcelona, , Spain

Site ES34011, Gerona, , Spain

Site ES34012, Madrid, , Spain

Site ES34001, Madrid, , Spain

Site ES34008, Madrid, , Spain

Site ES34005, Pamplona, , Spain

Site ES34010, Santiago de Compostela, , Spain

Site SE46001, Göteborg, , Sweden

Site SE46003, Umeå, , Sweden

Site TW88607, Gueishan, , Taiwan

Site TW88603, Kaohsiung, , Taiwan

Site TW88601, Kaohsiung, , Taiwan

Site TW88602, Taichung, , Taiwan

Site TW88606, Taipei, , Taiwan

Site TH66001, Hat Yai, Songkla, Thailand

Site TH66002, Bangkok, , Thailand

Site TR90002, Besevler, Ankara, Turkey

Site GB44009, Bebington, , United Kingdom

Site GB44003, Belfast, , United Kingdom

Site GB44004, Bristol, , United Kingdom

Site GB44014, Cambridge, , United Kingdom

Site GB44005, Cardiff, , United Kingdom

Site GB44002, Glasgow, , United Kingdom

Site GB44006, London, , United Kingdom

Site GB44007, Manchester, , United Kingdom

Site GB44008, Northwood, , United Kingdom

Site GB44016, Nottingham, , United Kingdom

Site GB44001, Sutton, , United Kingdom

Contact Details

Name: Associate Medical Director

Affiliation: Astellas Pharma Global Development, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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