← Back to searchRecruitingRecruiting
A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
NCT02960022 · Astellas Pharma Inc
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
About this study
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
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 design
Enrollment target: 900 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2016-12-22
Estimated completion: 2029-07-31
Last updated: 2026-04-13
Interventions
Drug: enzalutamideDrug: abiraterone acetateDrug: prednisoneDrug: Leuprolide acetate
Primary outcomes
- • Number of participants with adverse events (Until End of Study (Up to 96 Months))
Sponsor
Astellas Pharma Global Development, Inc. · industry
With: Pfizer
Contacts & investigators
ContactAstellas Pharma Global Development · contact · astellas.registration@astellas.com · 800-888-7704
InvestigatorAssociate Medical Director · study_director, Astellas Pharma Global Development, Inc.
All locations (241)
Site US10052Completed
Anchorage, Alaska, United States
Site US10011Completed
Tucson, Arizona, United States
Site US10040Completed
Los Angeles, California, United States
Site US10009Completed
Los Angeles, California, United States
Site US10067Recruiting
Orange, California, United States
Site US10008Completed
San Bernardino, California, United States
Site US10042Completed
San Diego, California, United States
Site US10028Completed
Stanford, California, United States
Site US10001Completed
Aurora, Colorado, United States
Site US10017Completed
Denver, Colorado, United States
Site US10050Completed
Washington D.C., District of Columbia, United States
Site US10049Completed
Daytona Beach, Florida, United States
Site US10048Withdrawn
Jacksonville, Florida, United States
Site US10002Active Not Recruiting
Chicago, Illinois, United States
Springfield Clinic, LLPActive Not Recruiting
Springfield, Illinois, United States
Site US10007Completed
Jeffersonville, Indiana, United States
University of Kansas Medical CenterActive Not Recruiting
Kansas City, Kansas, United States
Site US10066Active Not Recruiting
Lenexa, Kansas, United States
Site US10029Completed
Towson, Maryland, United States
Site US10032Completed
St Louis, Missouri, United States
Nebraska Medical HospitalActive Not Recruiting
Omaha, Nebraska, United States
Site US10023Active Not Recruiting
Omaha, Nebraska, United States
Site US10004Active Not Recruiting
Hackensack, New Jersey, United States
Site US10024Active Not Recruiting
Garden City, New York, United States
Site US10055Completed
New York, New York, United States
Site US10059Completed
New York, New York, United States
Hudson Valley Urology, PCActive Not Recruiting
Poughkeepsie, New York, United States
Site US10053Completed
Syracuse, New York, United States
Site US10030Completed
Chapel Hill, North Carolina, United States
Site US10062Active Not Recruiting
Charlotte, North Carolina, United States
Site US10020Withdrawn
Concord, North Carolina, United States
Site US10031Terminated
Greensboro, North Carolina, United States
Eastern Urological AssociatesCompleted
Greenville, North Carolina, United States
Site US10046Completed
Winston-Salem, North Carolina, United States
Site US10035Completed
Cincinnati, Ohio, United States
Site US10022Completed
Springfield, Oregon, United States
Site US10027Completed
Lancaster, Pennsylvania, United States
Site US10005Active Not Recruiting
Pittsburgh, Pennsylvania, United States
Site US10018Active Not Recruiting
Charleston, South Carolina, United States
Carolina Urologic Research CenterActive Not Recruiting
Myrtle Beach, South Carolina, United States
Site US10003Withdrawn
Myrtle Beach, South Carolina, United States
Site US10041Active Not Recruiting
Nashville, Tennessee, United States
Site US10010Active Not Recruiting
Dallas, Texas, United States
Site US10034Completed
Houston, Texas, United States
Site US10043Active Not Recruiting
Houston, Texas, United States
Site US10014Completed
Norfolk, Virginia, United States
Site US10015Active Not Recruiting
Virginia Beach, Virginia, United States
Virginia Mason Medical CenterActive Not Recruiting
Seattle, Washington, United States
Site US10038Completed
Seattle, Washington, United States
Site US10021Active Not Recruiting
Madison, Wisconsin, United States
Site AR54005Completed
Buenos Aires, Buenos Aires F.D., Argentina
Site AR54007Active Not Recruiting
Rosario, Santa Fe Province, Argentina
Site AR54008Active Not Recruiting
Buenos Aires, Argentina
Site AR54003Completed
Cordorba, Argentina
Site AR54006Active Not Recruiting
San Miguel de Tucumán, Argentina
Site AR54002Completed
San Miguel de Tucumán, Argentina
Site AU61014Completed
Albury, New South Wales, Australia
Site AU61001Completed
Tweed Heads, New South Wales, Australia
Site AU61012Completed
Wahroonga, New South Wales, Australia
Site AU61017Active Not Recruiting
Wahroonga, New South Wales, Australia
Site AU61006Active Not Recruiting
Ashford, Australia
Site AU61019Active Not Recruiting
Ballarat, Australia
Site AU61007Completed
East Bentleigh, Australia
Site AU61009Completed
Malvern, Australia
Site AU61021Completed
Parkville, Australia
Site AU61008Completed
South Brisbane, Australia
Site AU61016Active Not Recruiting
St Albans, Australia
Site AU61004Active Not Recruiting
Westmead, Australia
Site AT43001Active Not Recruiting
Vienna, Austria
Site BE32002Active Not Recruiting
Kortrijk, West-Vlaanderen, Belgium
Site BE32009Active Not Recruiting
Anderlecht, Belgium
Site BE32004Active Not Recruiting
Brussels, Belgium
Site BE32005Active Not Recruiting
Ghent, Belgium
Site BE32011Active Not Recruiting
Ghent, Belgium
Site BE32007Completed
Hasselt, Belgium
Site BE32008Completed
Leuven, Belgium
Site BE32001Completed
Liège, Belgium
Site BE32003Completed
Turnhout, Belgium
Site BR55007Active Not Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Site BR55009Active Not Recruiting
Bahia, Brazil
Site BR55008Active Not Recruiting
Campinas, Brazil
Site BR55004Recruiting
Ijuí, Brazil
Site BR55011Active Not Recruiting
Jaú, Brazil
Site BR55002Active Not Recruiting
Rio Grande, Brazil
Site BR55010Active Not Recruiting
Santo André, Brazil
Site CA15003Completed
Kingston, Ontario, Canada
Site CA15021Active Not Recruiting
Toronto, Ontario, Canada
Site CA15001Terminated
Granby, Quebec, Canada
Site CA15019Active Not Recruiting
Abbotsford British Columbia, Canada
Site CA15020Active Not Recruiting
Greenville, Canada
Site CA15011Active Not Recruiting
Montreal, Canada
Site CA15017Active Not Recruiting
Oakville, Canada
Site CA15022Active Not Recruiting
Québec, Canada
Site CL56007Active Not Recruiting
Santiago, RM, Chile
Site CL56005Active Not Recruiting
Santiago, RM, Chile
Site CL56006Active Not Recruiting
Viña del Mar, Valparaiso, Chile
Site CL56004Active Not Recruiting
IX Region, Chile
Site CL56002Completed
Santiago, Chile
Site CL56001Active Not Recruiting
Viña del Mar, Chile
Site CN86003Active Not Recruiting
Hubei, China
Site CN86010Active Not Recruiting
Hunan, China
Site CN86005Active Not Recruiting
Nanjing, China
Site CZ42004Active Not Recruiting
Olomouc, Czechia
Site CZ42002Active Not Recruiting
Olomouc, Czechia
Site CZ42001Completed
Prague, Czechia
Site CZ42003Completed
Prague, Czechia
Site DK45002Active Not Recruiting
Aalborg, North Denmark, Denmark
Site DK45003Active Not Recruiting
Aarhus, Denmark
Site DK45001Completed
Copenhagen, Denmark
Site DK45004Active Not Recruiting
Herlev, Denmark
Site DK45006Completed
Vejle, Denmark
Site FL35802Active Not Recruiting
Tampere, Finland
Site FL35805Active Not Recruiting
Turku, Finland
Site FR33021Completed
Bordeaux, France
Site FR33008Completed
La Roche-sur-Yon, France
Site FR33010Completed
Lille, France
Site FR33002Completed
Lyon, France
Site FR33020Completed
Montpellier, France
Site FR33006Completed
Nîmes, France
Site FR33003Completed
Paris, France
Site FR33017Completed
Paris, France
Site FR33001Completed
Saint-Herblain, France
Site FR33019Completed
Strasbourg, France
Site FR33022Completed
Strasbourg, France
Site FR33004Completed
Villejuif, France
Site GE99501Completed
Tbilisi, Georgia
Site DE49004Completed
Nürtingen, Baden-Wurttemberg, Germany
Site DE49007Completed
Waldshut-Tiengen, Baden-Wurttemberg, Germany
Site DE49006Active Not Recruiting
Mannheim, DE, Germany
Site DE49001Completed
Duisburg, North Rhine-Westphalia, Germany
Site DE49010Active Not Recruiting
Bonn, Germany
Site DE49003Active Not Recruiting
Hamburg, Germany
Site DE49013Completed
Hamburg, Germany
Site HK85202Active Not Recruiting
Hong Kong, Hong Kong
Site IL97206Recruiting
Haifa, Israel
Site IL97205Active Not Recruiting
Jerusalem, Israel
Site IL97202Completed
Peth Tikva, Israel
Site IL97204Completed
Ramat Gan, Israel
Site IL97203Completed
Tzrifin Beer Yakov, Israel
Site IT39008Active Not Recruiting
Faenza (RA), Emilia-Romagna, Italy
Site IT39001Completed
Arezzo, Italy
Site IT39011Active Not Recruiting
Candiolo, Italy
Site IT39004Active Not Recruiting
Cremona, Italy
Site IT39002Completed
Forlì, Italy
Site IT39005Completed
Roma, Italy
Site IT39009Active Not Recruiting
Toscana, Italy
Site IT39006Active Not Recruiting
Trento, Italy
Toho University Sakura Medical CenterActive Not Recruiting
Sakura-shi, Chiba, Japan
Kyushu University HospitalCompleted
Higashiku, Fukuoka, Japan
Gunma University HospitalActive Not Recruiting
Maebashi, Gunma, Japan
Kagawa University HospitalActive Not Recruiting
Kida-gun, Kagawa-ken, Japan
Yokohama City University Medical CenterActive Not Recruiting
Yokohama, Kanagawa, Japan
Kindai University HospitalActive Not Recruiting
Sayama, Osaka, Japan
Nippon Medical School HospitalActive Not Recruiting
Bunkyo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer ResearchCompleted
Koutou-ku, Tokyo, Japan
Yamaguchi University HospitalActive Not Recruiting
Ube, Yamaguchi, Japan
Chiba cancer centerActive Not Recruiting
Chiba, Japan
Harasanshin hospitalActive Not Recruiting
Fukuoka, Japan
Kyoto University hospitalActive Not Recruiting
Kyoto, Japan
Niigata University Medical and Dental HospitalCompleted
Niigata, Japan
Osaka Metropolitan University HospitalActive Not Recruiting
Osaka, Japan
Site MY60001Completed
Kuching, Malaysia
Site MD37301Active Not Recruiting
Chisinau, Moldova
Site NL31010Active Not Recruiting
Amsterdam, Netherlands
Site NL31009Active Not Recruiting
Den Helder, Netherlands
Site NL31004Active Not Recruiting
Maastricht, Netherlands
Site NL31011Active Not Recruiting
Rotterdam, Netherlands
Site NZ64002Active Not Recruiting
Auckland, New Zealand
Site NZ64005Active Not Recruiting
Dunedin, New Zealand
Site NZ64001Active Not Recruiting
Hamilton, New Zealand
Site NO47001Active Not Recruiting
Stavanger, Norway
Site PL48002Active Not Recruiting
Gdansk, Poland
Site PL48001Active Not Recruiting
Mysłowice, Poland
Site PL48004Completed
Pozman, Poland
Site PL48005Active Not Recruiting
Słupsk, Poland
Site PL48011Active Not Recruiting
Warsaw, Poland
Site PL48003Active Not Recruiting
Wroclaw, Poland
Site RO40003Active Not Recruiting
Bucharest, Romania
Site RO40001Active Not Recruiting
Cluj-Napoca, Romania
Site RO40004Active Not Recruiting
Cluj-Napoca, Romania
Site RU70008Active Not Recruiting
Ivanovo, Russia
Site RU70001Active Not Recruiting
Moscow, Russia
Site RU70005Active Not Recruiting
Omsk, Russia
Site RU70009Active Not Recruiting
Saint Petersburg, Russia
Site RU70003Active Not Recruiting
Saint Petersburg, Russia
Site RU70006Active Not Recruiting
Saint Petersburg, Russia
Site RS38102Completed
Belgrade, Serbia
Site RS38101Active Not Recruiting
Belgrade, Serbia
Site SK10223Active Not Recruiting
Bratislava, Slovakia
Site SK42109Active Not Recruiting
Košice, Slovakia
Site SK42106Completed
Košice, Slovakia
Site SK42105Active Not Recruiting
Nitra, Slovakia
Site SK42103Active Not Recruiting
Prešov, Slovakia
Site SK42108Active Not Recruiting
Trenčín, Slovakia
Site SK42107Active Not Recruiting
Žilina, Slovakia
Site ZA27001Completed
George, South Africa
Site KR82008Active Not Recruiting
Busan, South Korea
Site KR82012Active Not Recruiting
Seongnam-si, South Korea
Site KR82005Completed
Seongnam-si, South Korea
Site KR82009Active Not Recruiting
Seoul, South Korea
Site KR82007Active Not Recruiting
Seoul, South Korea
Site KR82011Active Not Recruiting
Seoul, South Korea
Site KR82001Active Not Recruiting
Seoul, South Korea
Site KR82002Active Not Recruiting
Seoul, South Korea
Site KR82003Completed
Seoul, South Korea
Site KR82004Completed
Seoul, South Korea
Site ES34007Completed
Barcelona, Spain
Site ES34003Active Not Recruiting
Barcelona, Spain
Site ES34004Withdrawn
Barcelona, Spain
Site ES34011Completed
Girona, Spain
Site ES34012Completed
Madrid, Spain
Site ES34001Completed
Madrid, Spain
Site ES34008Active Not Recruiting
Madrid, Spain
Site ES34005Completed
Pamplona, Spain
Site ES34014Active Not Recruiting
Salamanca, Spain
Site ES34010Active Not Recruiting
Santiago de Compostela, Spain
Site SE46001Completed
Gothenburg, Sweden
Site SE46003Active Not Recruiting
Umeå, Sweden
Site TW88607Active Not Recruiting
Guishan, Taiwan
Site TW88603Active Not Recruiting
Kaohsiung City, Taiwan
Site TW88601Completed
Kaohsiung City, Taiwan
Site TW88602Active Not Recruiting
Taichung, Taiwan
Site TW88606Active Not Recruiting
Taipei, Taiwan
Site TH66001Active Not Recruiting
Hat Yai, Changwat Songkhla, Thailand
Site TH66002Completed
Bangkok, Thailand
Site TR90002Active Not Recruiting
Beşevler, Ankara, Turkey (Türkiye)
Site UA38004Active Not Recruiting
Dnipro, Ukraine
Site UA38005Active Not Recruiting
Kharkiv, Ukraine
Site UA38001Active Not Recruiting
Kyiv, Ukraine
Site UA38003Active Not Recruiting
Uzhhorod, Ukraine
Site GB44009Completed
Bebington, United Kingdom
Site GB44003Completed
Belfast, United Kingdom
Site GB44004Completed
Bristol, United Kingdom
Site GB44014Active Not Recruiting
Cambridge, United Kingdom
Site GB44005Active Not Recruiting
Cardiff, United Kingdom
Site GB44002Completed
Glasgow, United Kingdom
Site GB44006Active Not Recruiting
London, United Kingdom
Site GB44007Active Not Recruiting
Manchester, United Kingdom
Site GB44008Completed
Northwood, United Kingdom
Site GB44016Active Not Recruiting
Nottingham, United Kingdom
Site GB44001Active Not Recruiting
Sutton, United Kingdom