A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
6 other identifiers
interventional
900
36 countries
231
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Dec 2016
Longer than P75 for phase_2 prostate-cancer
231 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2016
CompletedFirst Posted
Study publicly available on registry
November 9, 2016
CompletedStudy Start
First participant enrolled
December 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2029
September 11, 2026
September 1, 2026
12.6 years
November 7, 2016
September 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events
Until End of Study (Up to 96 Months)
Study Arms (3)
enzalutamide
EXPERIMENTALSubjects will receive enzalutamide orally once daily at the same time each day
enzalutamide plus abiraterone acetate and prednisone
EXPERIMENTALSubjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide once daily
Enzalutamide plus leuprolide acetate
EXPERIMENTALSubjects enrolling from study MDV3100-13 (EMBARK) study may receive leuprolide acetate once every 12 weeks in addition to enzalutamide once daily
Interventions
Subjects will receive enzalutamide orally once daily at the same time each day.
Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide
Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide
Subjects enrolling from study MDV3100-13 (EMBARK) study may receive leuprolide acetate once every 12 weeks in addition to enzalutamide once daily
Eligibility Criteria
You may qualify if:
- Subject must currently be receiving enzalutamide or assigned to receive enzalutamide (if on treatment suspension) for prostate cancer in a study sponsored by Astellas or Medivation and, based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
- Subject is able to continue on the treatment regimen that they were receiving or were assigned to receive in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dose change in Androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.
- Subject is able to swallow enzalutamide capsules and comply with study requirements.
- Subject and female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective and 1 must be a barrier method throughout the study and for 3 months after final enzalutamide administration.
- Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
- Subject agrees not to participate in another interventional study while on treatment.
- Canada Specific:
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization for the United States sites) must be obtained from the subject prior to any study-related procedures.
- Subject must currently be receiving enzalutamide for breast cancer in a study sponsored by Astellas or Medivation/Pfizer and based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
- Subject is able to continue on the treatment regimen that they were receiving in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.
- Subject is able to swallow enzalutamide capsules and comply with study requirements.
- Subject is either:
- Of nonchildbearing potential:
- postmenopausal (defined as no spontaneous menses for at least 12 months prior to Day 1 with follicle stimulating hormone (FSH) \> 40 IU/L at Day 1 for women \< 55 years of age),
- documented surgically sterile or status post hysterectomy (at least 1 month prior to Day 1),
- +12 more criteria
You may not qualify if:
- Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling from.
- Subject requires treatment with or plans to use either of the following:
- New systemic therapy for subjects cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment.
- Investigational therapy other than enzalutamide.
- Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
- Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.
- Canada Specific:
- Subject will be excluded from participation if any of the following apply:
- Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which they are enrolling from.
- Subject requires treatment with or plans to use any of the following:
- New systemic therapy for their cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment.
- Investigational therapy other than enzalutamide.
- Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
- Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data in the opinion of the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Global Development, Inc.lead
- Pfizercollaborator
Study Sites (234)
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 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 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 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 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 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 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 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Associate Medical Director
Astellas Pharma Global Development, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2016
First Posted
November 9, 2016
Study Start
December 22, 2016
Primary Completion (Estimated)
July 31, 2029
Study Completion (Estimated)
July 31, 2029
Last Updated
September 11, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.