A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
September 10, 2026 updated by: Astellas Pharma Global Development, Inc.
A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
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.
Study Overview
Status
Status
Active, not recruiting
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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.
Study Type
Study Type
Interventional
Enrollment (Estimated)
Enrollment
900
Phase
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
Study Contact
- Name: Astellas Pharma Global Development
- Phone Number: 800-888-7704
- Email: astellas.registration@astellas.com
Study Locations
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Buenos Aires, Argentina
- Site AR54008
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Cordorba, Argentina
- Site AR54003
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San Miguel de Tucumán, Argentina, T4000IAK
- Site AR54006
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San Miguel de Tucumán, Argentina
- Site AR54002
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Buenos Aires F.D.
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Buenos Aires, Buenos Aires F.D., Argentina, C1120AAT
- Site AR54005
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000DSV
- Site AR54007
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Ashford, Australia
- Site AU61006
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Ballarat, Australia, 3350
- Site AU61019
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East Bentleigh, Australia, 3165
- Site AU61007
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Malvern, Australia
- Site AU61009
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Parkville, Australia
- Site AU61021
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South Brisbane, Australia
- Site AU61008
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St Albans, Australia, 3021
- Site AU61016
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Westmead, Australia, 2145
- Site AU61004
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New South Wales
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Albury, New South Wales, Australia, 2640
- Site AU61014
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Tweed Heads, New South Wales, Australia, 2485
- Site AU61001
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Wahroonga, New South Wales, Australia, 2076
- Site AU61012
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Wahroonga, New South Wales, Australia, 2076
- Site AU61017
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Vienna, Austria, 1090
- Site AT43001
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Anderlecht, Belgium, 1070
- Site BE32009
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Brussels, Belgium, B-1090
- Site BE32004
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Ghent, Belgium, 9000
- Site BE32005
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Ghent, Belgium, 9000
- Site BE32011
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Hasselt, Belgium
- Site BE32007
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Leuven, Belgium, 3000
- Site BE32008
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Liège, Belgium, 4000
- Site BE32001
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Turnhout, Belgium, 2300
- Site BE32003
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West-Vlaanderen
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Kortrijk, West-Vlaanderen, Belgium, 8500
- Site BE32002
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Bahia, Brazil, 41253-190
- Site BR55009
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Campinas, Brazil
- Site BR55008
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Jaú, Brazil
- Site BR55011
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Rio Grande, Brazil, 90610-000
- Site BR55002
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Santo André, Brazil, 09060-650
- Site BR55010
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90430-090
- Site BR55007
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Abbotsford British Columbia, Canada, V2S 3N5
- Site CA15019
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Greenville, Canada, L6R 3J7 27834
- Site CA15020
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Montreal, Canada
- Site CA15011
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Oakville, Canada, L6H 3P1
- Site CA15017
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Québec, Canada, QC / G1S 4L8
- Site CA15022
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Ontario
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Kingston, Ontario, Canada, K7L 3J7
- Site CA15003
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Toronto, Ontario, Canada, M4N 3M5
- Site CA15021
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Quebec
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Granby, Quebec, Canada, J2G 8Z9
- Site CA15001
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IX Region, Chile
- Site CL56004
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Santiago, Chile
- Site CL56002
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Viña del Mar, Chile
- Site CL56001
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RM
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Santiago, RM, Chile, 7500787
- Site CL56007
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Santiago, RM, Chile, 75009
- Site CL56005
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2520598
- Site CL56006
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Hubei, China, 430030
- Site CN86003
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Hunan, China, 410013
- Site CN86010
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Nanjing, China
- Site CN86005
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Olomouc, Czechia, 775 20
- Site CZ42004
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Olomouc, Czechia, 779 00
- Site CZ42002
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Prague, Czechia, 16000
- Site CZ42001
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Prague, Czechia
- Site CZ42003
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Aarhus, Denmark, 8200
- Site DK45003
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Copenhagen, Denmark, 2100
- Site DK45001
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Herlev, Denmark, 2730
- Site DK45004
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Vejle, Denmark, 7100
- Site DK45006
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North Denmark
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Aalborg, North Denmark, Denmark, 9000
- Site DK45002
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Tampere, Finland
- Site FL35802
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Turku, Finland, 20521
- Site FL35805
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Bordeaux, France, 33076
- Site FR33021
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La Roche-sur-Yon, France, 85925
- Site FR33008
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Lille, France, 59037
- Site FR33010
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Lyon, France, 69003
- Site FR33002
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Montpellier, France, 34298
- Site FR33020
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Nîmes, France, 30029
- Site FR33006
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Paris, France
- Site FR33003
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Paris, France
- Site FR33017
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Saint-Herblain, France
- Site FR33001
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Strasbourg, France, 67000
- Site FR33019
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Strasbourg, France, 67098
- Site FR33022
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Villejuif, France
- Site FR33004
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Tbilisi, Georgia, GE- 0186
- Site GE99501
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Bonn, Germany, 53111
- Site DE49010
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Hamburg, Germany, 22081
- Site DE49003
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Hamburg, Germany
- Site DE49013
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Baden-Wurttemberg
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Nürtingen, Baden-Wurttemberg, Germany, 72622
- Site DE49004
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Waldshut-Tiengen, Baden-Wurttemberg, Germany, 79761
- Site DE49007
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DE
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Mannheim, DE, Germany, 68167
- Site DE49006
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North Rhine-Westphalia
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Duisburg, North Rhine-Westphalia, Germany, 47179
- Site DE49001
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Hong Kong, Hong Kong
- Site HK85202
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Jerusalem, Israel
- Site IL97205
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Peth Tikva, Israel
- Site IL97202
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Ramat Gan, Israel
- Site IL97204
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Tzrifin Beer Yakov, Israel
- Site IL97203
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Arezzo, Italy
- Site IT39001
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Candiolo, Italy
- Site IT39011
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Cremona, Italy
- Site IT39004
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Forlì, Italy
- Site IT39002
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Roma, Italy
- Site IT39005
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Toscana, Italy
- Site IT39009
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Trento, Italy, 38122
- Site IT39006
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Emilia-Romagna
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Faenza (RA), Emilia-Romagna, Italy, 48018
- Site IT39008
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Chiba, Japan, 260-8717
- Chiba Cancer Center
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Fukuoka, Japan, 812-0033
- Harasanshin hospital
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Kyoto, Japan, 606-8507
- Kyoto University Hospital
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Niigata, Japan, 951-8520
- Niigata University Medical and Dental Hospital
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Osaka, Japan
- Osaka Metropolitan university Hospital
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Chiba
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Sakura-shi, Chiba, Japan
- Toho University Sakura Medical Center
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Fukuoka
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Higashiku, Fukuoka, Japan
- Kyushu University Hospital
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Gunma
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Maebashi, Gunma, Japan
- Gunma University Hospital
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Kagawa-ken
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Kida-gun, Kagawa-ken, Japan
- Kagawa University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japan, 232-0024
- Yokohama City University Medical Center
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Osaka
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Sayama, Osaka, Japan, 589-8511
- Kindai University Hospital
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Tokyo
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Bunkyo-ku, Tokyo, Japan
- Nippon Medical School Hospital
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Koutou-ku, Tokyo, Japan
- The Cancer Institute Hospital of Japanese Foundation For Cancer Research
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Yamaguchi
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Ube, Yamaguchi, Japan
- Yamaguchi University Hospital
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Kuching, Malaysia, 93586
- Site MY60001
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Chisinau, Moldova
- Site MD37301
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Amsterdam, Netherlands, 1066 CX
- Site NL31010
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Den Helder, Netherlands
- Site NL31009
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Maastricht, Netherlands, 6229
- Site NL31004
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Rotterdam, Netherlands, 3045 PM
- Site NL31011
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Auckland, New Zealand, V2S 3N5
- Site NZ64002
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Dunedin, New Zealand, 9016
- Site NZ64005
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Hamilton, New Zealand
- Site NZ64001
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Stavanger, Norway
- Site NO47001
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Gdansk, Poland
- Site PL48002
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Mysłowice, Poland
- Site PL48001
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Pozman, Poland
- Site PL48004
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Słupsk, Poland, 76-200
- Site PL48005
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Warsaw, Poland, 04-073
- Site PL48011
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Wroclaw, Poland, 54-144
- Site PL48003
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Bucharest, Romania, 50659
- Site RO40003
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Cluj-Napoca, Romania, 400015
- Site RO40001
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Cluj-Napoca, Romania, 400015
- Site RO40004
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Ivanovo, Russia, 153040
- Site RU70008
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Moscow, Russia, 125284
- Site RU70001
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Omsk, Russia
- Site RU70005
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Saint Petersburg, Russia, 191104
- Site RU70009
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Saint Petersburg, Russia
- Site RU70003
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Saint Petersburg, Russia
- Site RU70006
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Belgrade, Serbia, 11040
- Site RS38102
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Belgrade, Serbia, 11080
- Site RS38101
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Bratislava, Slovakia
- Site SK10223
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Košice, Slovakia, 04001
- Site SK42109
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Košice, Slovakia, 04191
- Site SK42106
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Nitra, Slovakia, 949 01
- Site SK42105
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Prešov, Slovakia, 080 01
- Site SK42103
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Trenčín, Slovakia, 91101
- Site SK42108
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Žilina, Slovakia
- Site SK42107
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George, South Africa, 6529
- Site ZA27001
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Busan, South Korea, 49241
- Site KR82008
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Seongnam-si, South Korea, 013620
- Site KR82012
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Seongnam-si, South Korea
- Site KR82005
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Seoul, South Korea
- Site KR82001
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Seoul, South Korea
- Site KR82003
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Seoul, South Korea
- Site KR82004
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Seoul, South Korea
- Site KR82002
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Seoul, South Korea, 03080
- Site KR82009
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Seoul, South Korea, 06351
- Site KR82007
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Seoul, South Korea, 138-736
- Site KR82011
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Barcelona, Spain
- Site ES34003
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Barcelona, Spain, 08036
- Site ES34007
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Girona, Spain, 17007
- Site ES34011
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Madrid, Spain
- Site ES34008
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Madrid, Spain, 28034
- Site ES34001
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Madrid, Spain, 28006
- Site ES34012
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Pamplona, Spain
- Site ES34005
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Salamanca, Spain
- Site ES34014
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Santiago de Compostela, Spain, 15706
- Site ES34010
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Gothenburg, Sweden, 41345
- Site SE46001
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Umeå, Sweden, 90185
- Site SE46003
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Guishan, Taiwan, 33305
- Site TW88607
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Kaohsiung City, Taiwan, 81362
- Site TW88603
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Kaohsiung City, Taiwan
- Site TW88601
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Taichung, Taiwan, 40447
- Site TW88602
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Taipei, Taiwan, 10002
- Site TW88606
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Bangkok, Thailand, 10330
- Site TH66002
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Changwat Songkhla
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Hat Yai, Changwat Songkhla, Thailand, 90110
- Site TH66001
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Ankara
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Beşevler, Ankara, Turkey (Türkiye), 06500
- Site TR90002
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Dnipro, Ukraine, 49005
- Site UA38004
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Kharkiv, Ukraine, 61037
- Site UA38005
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Kyiv, Ukraine, 02125
- Site UA38001
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Uzhhorod, Ukraine, 88000
- Site UA38003
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Bebington, United Kingdom
- Site GB44009
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Belfast, United Kingdom
- Site GB44003
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Bristol, United Kingdom, BS28HW
- Site GB44004
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Cambridge, United Kingdom
- Site GB44014
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Cardiff, United Kingdom, CF4 4XN
- Site GB44005
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Glasgow, United Kingdom
- Site GB44002
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London, United Kingdom
- Site GB44006
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Manchester, United Kingdom, M20 4BX
- Site GB44007
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Northwood, United Kingdom
- Site GB44008
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Nottingham, United Kingdom, NG5 1PB
- Site GB44016
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Sutton, United Kingdom
- Site GB44001
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Alaska
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Anchorage, Alaska, United States, 99503
- Site US10052
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Arizona
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Tucson, Arizona, United States, 85741
- Site US10011
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California
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Los Angeles, California, United States, 90024
- Site US10040
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Los Angeles, California, United States, 90048
- Site US10009
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San Bernardino, California, United States, 92404
- Site US10008
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San Diego, California, United States, 92108
- Site US10042
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Stanford, California, United States, 94305
- Site US10028
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Colorado
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Aurora, Colorado, United States, 80045
- Site US10001
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Denver, Colorado, United States, 80211
- Site US10017
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District of Columbia
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Washington D.C., District of Columbia, United States, 20037
- Site US10050
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Florida
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Daytona Beach, Florida, United States, 32114
- Site US10049
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Illinois
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Chicago, Illinois, United States, 60637
- Site US10002
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Springfield, Illinois, United States, 62701
- Springfield Clinic, LLP
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Indiana
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Jeffersonville, Indiana, United States, 47130
- Site US10007
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Lenexa, Kansas, United States, 66214-1656
- Site US10066
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Maryland
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Towson, Maryland, United States, 21204
- Site US10029
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Missouri
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St Louis, Missouri, United States, 63110
- Site US10032
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Nebraska
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Omaha, Nebraska, United States, 68114
- Nebraska Medical Hospital
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Omaha, Nebraska, United States, 68130
- Site US10023
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Site US10004
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New York
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Garden City, New York, United States, 11530
- Site US10024
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New York, New York, United States, 10065
- Site US10055
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New York, New York, United States, 10065
- Site US10059
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Poughkeepsie, New York, United States, 12601
- Hudson Valley Urology, PC
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Syracuse, New York, United States, 13210
- Site US10053
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Site US10030
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Charlotte, North Carolina, United States, 28207
- Site US10062
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Greensboro, North Carolina, United States, 27403
- Site US10031
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Greenville, North Carolina, United States, 27834
- Eastern Urological Associates
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Winston-Salem, North Carolina, United States, 27157
- Site US10046
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Ohio
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Cincinnati, Ohio, United States, 45212
- Site US10035
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Oregon
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Springfield, Oregon, United States, 97477
- Site US10022
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Pennsylvania
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Lancaster, Pennsylvania, United States, 17604
- Site US10027
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Pittsburgh, Pennsylvania, United States, 15232
- Site US10005
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South Carolina
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Charleston, South Carolina, United States, 29414
- Site US10018
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Myrtle Beach, South Carolina, United States, 29572
- Carolina Urologic Research Center
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Tennessee
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Nashville, Tennessee, United States, 37232-2765
- Site US10041
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Texas
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Dallas, Texas, United States, 75231
- Site US10010
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Houston, Texas, United States, 77024
- Site US10034
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Houston, Texas, United States, 77030
- Site US10043
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Virginia
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Norfolk, Virginia, United States, 23502
- Site US10014
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Virginia Beach, Virginia, United States, 23462
- Site US10015
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Washington
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Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
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Seattle, Washington, United States, 98109
- Site US10038
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Wisconsin
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Madison, Wisconsin, United States, 53792
- Site US10021
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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),
- Or, if of childbearing potential,
- must have a negative urine pregnancy test at Day 1 before the first dose of study drug is administered,
- must use 2 acceptable methods of birth control starting at Day 1 and through 6 months after the final study drug administration,
- must not donate ova starting at first administration of study intervention and throughout 6 months after final study intervention administration.
The 2 acceptable methods of birth control are as follows or per local guidelines where these require additional description of contraceptive methods:
- A barrier method (e.g., condom by a male partner) is required; AND
- One of the following is required:
- Placement of an intrauterine device (IUD) or intrauterine system (IUS);
- Additional barrier method including occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
- Vasectomy or other surgical castration at least 6 months before Day 1.
- The subject must not be breastfeeding at Day 1 or during the study period, and for 6 months after the final study drug administration.
- Subject agrees not to participate in another interventional study while on treatment.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
3
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: enzalutamide
Subjects will receive enzalutamide orally once daily at the same time each day
|
Subjects will receive enzalutamide orally once daily at the same time each day.
Other Names:
|
|
Experimental: enzalutamide plus abiraterone acetate and prednisone
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 once daily
|
Subjects will receive enzalutamide orally once daily at the same time each day.
Other Names:
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
|
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Experimental: Enzalutamide plus leuprolide acetate
Subjects enrolling from study MDV3100-13 (EMBARK) study may receive leuprolide acetate once every 12 weeks in addition to enzalutamide once daily
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Subjects will receive enzalutamide orally once daily at the same time each day.
Other Names:
Subjects enrolling from study MDV3100-13 (EMBARK) study may receive leuprolide acetate once every 12 weeks in addition to enzalutamide once daily
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Number of participants with adverse events
Time Frame: Until End of Study (Up to 96 Months)
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Until End of Study (Up to 96 Months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Director: Associate Medical Director, Astellas Pharma Global Development, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
Study Start
December 22, 2016
Primary Completion (Estimated)
Primary Completion
July 31, 2029
Study Completion (Estimated)
Study Completion
July 31, 2029
Study Registration Dates
First Submitted
First Submitted
November 7, 2016
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
November 7, 2016
First Posted (Estimated)
First Posted
November 9, 2016
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
September 11, 2026
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
September 10, 2026
Last Verified
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Prostatic Neoplasms
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Pituitary Hormone-Releasing Hormones
- Hypothalamic Hormones
- Peptide Hormones
- Neuropeptides
- Peptides
- Amino Acids, Peptides, and Proteins
- Oligopeptides
- Nerve Tissue Proteins
- Proteins
- Polycyclic Compounds
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Pregnadienediols
- Androstenes
- Androstanes
- Gonadotropin-Releasing Hormone
- Abiraterone Acetate
- Prednisone
- Leuprolide
- enzalutamide
Other Study ID Numbers
Other Study ID Numbers
- 9785-CL-0123
- 2016 (U.S. NIH Grant/Contract)
- 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
- 2016-001694-32 (EudraCT Number)
- jRCT2031220674 (Registry Identifier: jRCT)
- 2023-510298-33-00 (Registry Identifier: EU CTIS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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/.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.