Prostate cancer drug enzalutamide tested for Long-Term safety in ongoing study

NCT ID NCT02960022

Disease control Sponsor: Astellas Pharma Global Development, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This study looks at the long-term safety of the drug enzalutamide in people with prostate cancer who have already been taking it in a previous study and are still benefiting. About 900 participants will continue their current treatment and be monitored for side effects. The goal is to gather more safety information over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 900 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2016

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States
Chiba cancer center

Chiba, 260-8717, Japan
Eastern Urological Associates

Greenville, North Carolina, 27834, United States
Gunma University Hospital

Maebashi, Gunma, Japan
Harasanshin hospital

Fukuoka, 812-0033, Japan
Hudson Valley Urology, PC

Poughkeepsie, New York, 12601, United States
Kagawa University Hospital

Kida-gun, Kagawa-ken, Japan
Kindai University Hospital

Sayama, Osaka, 589-8511, Japan
Kyoto University hospital

Kyoto, 606-8507, Japan
Kyushu University Hospital

Higashiku, Fukuoka, Japan
Nebraska Medical Hospital

Omaha, Nebraska, 68114, United States
Niigata University Medical and Dental Hospital

Niigata, 951-8520, Japan
Nippon Medical School Hospital

Bunkyo-ku, Tokyo, Japan
Osaka Metropolitan University Hospital

Osaka, Japan
Site AR54002

San Miguel de Tucumán, Argentina
Site AR54003

Cordorba, Argentina
Site AR54005

Buenos Aires, Buenos Aires F.D., C1120AAT, Argentina
Site AR54006

San Miguel de Tucumán, T4000IAK, Argentina
Site AR54007

Rosario, Santa Fe Province, S2000DSV, Argentina
Site AR54008

Buenos Aires, Argentina
Site AT43001

Vienna, 1090, Austria
Site AU61001

Tweed Heads, New South Wales, 2485, Australia
Site AU61004

Westmead, 2145, Australia
Site AU61006

Ashford, Australia
Site AU61007

East Bentleigh, 3165, Australia
Site AU61008

South Brisbane, Australia
Site AU61009

Malvern, Australia
Site AU61012

Wahroonga, New South Wales, 2076, Australia
Site AU61014

Albury, New South Wales, 2640, Australia
Site AU61016

St Albans, 3021, Australia
Site AU61017

Wahroonga, New South Wales, 2076, Australia
Site AU61019

Ballarat, 3350, Australia
Site AU61021

Parkville, Australia
Site BE32001

Liège, 4000, Belgium
Site BE32002

Kortrijk, West-Vlaanderen, 8500, Belgium
Site BE32003

Turnhout, 2300, Belgium
Site BE32004

Brussels, B-1090, Belgium
Site BE32005

Ghent, 9000, Belgium
Site BE32007

Hasselt, Belgium
Site BE32008

Leuven, 3000, Belgium
Site BE32009

Anderlecht, 1070, Belgium
Site BE32011

Ghent, 9000, Belgium
Site BR55002

Rio Grande, 90610-000, Brazil
Site BR55007

Porto Alegre, Rio Grande do Sul, 90430-090, Brazil
Site BR55008

Campinas, Brazil
Site BR55009

Bahia, 41253-190, Brazil
Site BR55010

Santo André, 09060-650, Brazil
Site BR55011

Jaú, Brazil
Site CA15001

Granby, Quebec, J2G 8Z9, Canada
Site CA15003

Kingston, Ontario, K7L 3J7, Canada
Site CA15011

Montreal, Canada
Site CA15017

Oakville, L6H 3P1, Canada
Site CA15019

Abbotsford British Columbia, V2S 3N5, Canada
Site CA15020

Greenville, L6R 3J7 27834, Canada
Site CA15021

Toronto, Ontario, M4N 3M5, Canada
Site CA15022

Québec, QC / G1S 4L8, Canada
Site CL56001

Viña del Mar, Chile
Site CL56002

Santiago, Chile
Site CL56004

IX Region, Chile
Site CL56005

Santiago, RM, 75009, Chile
Site CL56006

Viña del Mar, Valparaiso, 2520598, Chile
Site CL56007

Santiago, RM, 7500787, Chile
Site CN86003

Hubei, 430030, China
Site CN86005

Nanjing, China
Site CN86010

Hunan, 410013, China
Site CZ42001

Prague, 16000, Czechia
Site CZ42002

Olomouc, 779 00, Czechia
Site CZ42003

Prague, Czechia
Site CZ42004

Olomouc, 775 20, Czechia
Site DE49001

Duisburg, North Rhine-Westphalia, 47179, Germany
Site DE49003

Hamburg, 22081, Germany
Site DE49004

Nürtingen, Baden-Wurttemberg, 72622, Germany
Site DE49006

Mannheim, DE, 68167, Germany
Site DE49007

Waldshut-Tiengen, Baden-Wurttemberg, 79761, Germany
Site DE49010

Bonn, 53111, Germany
Site DE49013

Hamburg, Germany
Site DK45001

Copenhagen, 2100, Denmark
Site DK45002

Aalborg, North Denmark, 9000, Denmark
Site DK45003

Aarhus, 8200, Denmark
Site DK45004

Herlev, 2730, Denmark
Site DK45006

Vejle, 7100, Denmark
Site ES34001

Madrid, 28034, Spain
Site ES34003

Barcelona, Spain
Site ES34005

Pamplona, Spain
Site ES34007

Barcelona, 08036, Spain
Site ES34008

Madrid, Spain
Site ES34010

Santiago de Compostela, 15706, Spain
Site ES34011

Girona, 17007, Spain
Site ES34012

Madrid, 28006, Spain
Site ES34014

Salamanca, Spain
Site FL35802

Tampere, Finland
Site FL35805

Turku, 20521, Finland
Site FR33001

Saint-Herblain, France
Site FR33002

Lyon, 69003, France
Site FR33003

Paris, France
Site FR33004

Villejuif, France
Site FR33006

Nîmes, 30029, France
Site FR33008

La Roche-sur-Yon, 85925, France
Site FR33010

Lille, 59037, France
Site FR33017

Paris, France
Site FR33019

Strasbourg, 67000, France
Site FR33020

Montpellier, 34298, France
Site FR33021

Bordeaux, 33076, France
Site FR33022

Strasbourg, 67098, France
Site GB44001

Sutton, United Kingdom
Site GB44002

Glasgow, United Kingdom
Site GB44003

Belfast, United Kingdom
Site GB44004

Bristol, BS28HW, United Kingdom
Site GB44005

Cardiff, CF4 4XN, United Kingdom
Site GB44006

London, United Kingdom
Site GB44007

Manchester, M20 4BX, United Kingdom
Site GB44008

Northwood, United Kingdom
Site GB44009

Bebington, United Kingdom
Site GB44014

Cambridge, United Kingdom
Site GB44016

Nottingham, NG5 1PB, United Kingdom
Site GE99501

Tbilisi, GE- 0186, Georgia
Site HK85202

Hong Kong, Hong Kong
Site IL97202

Peth Tikva, Israel
Site IL97203

Tzrifin Beer Yakov, Israel
Site IL97204

Ramat Gan, Israel
Site IL97205

Jerusalem, Israel
Site IT39001

Arezzo, Italy
Site IT39002

Forlì, Italy
Site IT39004

Cremona, Italy
Site IT39005

Roma, Italy
Site IT39006

Trento, 38122, Italy
Site IT39008

Faenza (RA), Emilia-Romagna, 48018, Italy
Site IT39009

Toscana, Italy
Site IT39011

Candiolo, Italy
Site KR82001

Seoul, South Korea
Site KR82002

Seoul, South Korea
Site KR82003

Seoul, South Korea
Site KR82004

Seoul, South Korea
Site KR82005

Seongnam-si, South Korea
Site KR82007

Seoul, 06351, South Korea
Site KR82008

Busan, 49241, South Korea
Site KR82009

Seoul, 03080, South Korea
Site KR82011

Seoul, 138-736, South Korea
Site KR82012

Seongnam-si, 013620, South Korea
Site MD37301

Chisinau, Moldova
Site MY60001

Kuching, 93586, Malaysia
Site NL31004

Maastricht, 6229, Netherlands
Site NL31009

Den Helder, Netherlands
Site NL31010

Amsterdam, 1066 CX, Netherlands
Site NL31011

Rotterdam, 3045 PM, Netherlands
Site NO47001

Stavanger, Norway
Site NZ64001

Hamilton, New Zealand
Site NZ64002

Auckland, V2S 3N5, New Zealand
Site NZ64005

Dunedin, 9016, New Zealand
Site PL48001

Mysłowice, Poland
Site PL48002

Gdansk, Poland
Site PL48003

Wroclaw, 54-144, Poland
Site PL48004

Pozman, Poland
Site PL48005

Słupsk, 76-200, Poland
Site PL48011

Warsaw, 04-073, Poland
Site RO40001

Cluj-Napoca, 400015, Romania
Site RO40003

Bucharest, 50659, Romania
Site RO40004

Cluj-Napoca, 400015, Romania
Site RS38101

Belgrade, 11080, Serbia
Site RS38102

Belgrade, 11040, Serbia
Site RU70001

Moscow, 125284, Russia
Site RU70003

Saint Petersburg, Russia
Site RU70005

Omsk, Russia
Site RU70006

Saint Petersburg, Russia
Site RU70008

Ivanovo, 153040, Russia
Site RU70009

Saint Petersburg, 191104, Russia
Site SE46001

Gothenburg, 41345, Sweden
Site SE46003

Umeå, 90185, Sweden
Site SK10223

Bratislava, Slovakia
Site SK42103

Prešov, 080 01, Slovakia
Site SK42105

Nitra, 949 01, Slovakia
Site SK42106

Košice, 04191, Slovakia
Site SK42107

Žilina, Slovakia
Site SK42108

Trenčín, 91101, Slovakia
Site SK42109

Košice, 04001, Slovakia
Site TH66001

Hat Yai, Changwat Songkhla, 90110, Thailand
Site TH66002

Bangkok, 10330, Thailand
Site TR90002

Beşevler, Ankara, 06500, Turkey (Türkiye)
Site TW88601

Kaohsiung City, Taiwan
Site TW88602

Taichung, 40447, Taiwan
Site TW88603

Kaohsiung City, 81362, Taiwan
Site TW88606

Taipei, 10002, Taiwan
Site TW88607

Guishan, 33305, Taiwan
Site UA38001

Kyiv, 02125, Ukraine
Site UA38003

Uzhhorod, 88000, Ukraine
Site UA38004

Dnipro, 49005, Ukraine
Site UA38005

Kharkiv, 61037, Ukraine
Site US10001

Aurora, Colorado, 80045, United States
Site US10002

Chicago, Illinois, 60637, United States
Site US10004

Hackensack, New Jersey, 07601, United States
Site US10005

Pittsburgh, Pennsylvania, 15232, United States
Site US10007

Jeffersonville, Indiana, 47130, United States
Site US10008

San Bernardino, California, 92404, United States
Site US10009

Los Angeles, California, 90048, United States
Site US10010

Dallas, Texas, 75231, United States
Site US10011

Tucson, Arizona, 85741, United States
Site US10014

Norfolk, Virginia, 23502, United States
Site US10015

Virginia Beach, Virginia, 23462, United States
Site US10017

Denver, Colorado, 80211, United States
Site US10018

Charleston, South Carolina, 29414, United States
Site US10021

Madison, Wisconsin, 53792, United States
Site US10022

Springfield, Oregon, 97477, United States
Site US10023

Omaha, Nebraska, 68130, United States
Site US10024

Garden City, New York, 11530, United States
Site US10027

Lancaster, Pennsylvania, 17604, United States
Site US10028

Stanford, California, 94305, United States
Site US10029

Towson, Maryland, 21204, United States
Site US10030

Chapel Hill, North Carolina, 27599, United States
Site US10031

Greensboro, North Carolina, 27403, United States
Site US10032

St Louis, Missouri, 63110, United States
Site US10034

Houston, Texas, 77024, United States
Site US10035

Cincinnati, Ohio, 45212, United States
Site US10038

Seattle, Washington, 98109, United States
Site US10040

Los Angeles, California, 90024, United States
Site US10041

Nashville, Tennessee, 37232-2765, United States
Site US10042

San Diego, California, 92108, United States
Site US10043

Houston, Texas, 77030, United States
Site US10046

Winston-Salem, North Carolina, 27157, United States
Site US10049

Daytona Beach, Florida, 32114, United States
Site US10050

Washington D.C., District of Columbia, 20037, United States
Site US10052

Anchorage, Alaska, 99503, United States
Site US10053

Syracuse, New York, 13210, United States
Site US10055

New York, New York, 10065, United States
Site US10059

New York, New York, 10065, United States
Site US10062

Charlotte, North Carolina, 28207, United States
Site US10066

Lenexa, Kansas, 66214-1656, United States
Site ZA27001

George, 6529, South Africa
Springfield Clinic, LLP

Springfield, Illinois, 62701, United States
The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koutou-ku, Tokyo, Japan
Toho University Sakura Medical Center

Sakura-shi, Chiba, Japan
University of Kansas Medical Center

Kansas City, Kansas, 66160, United States
Virginia Mason Medical Center

Seattle, Washington, 98101, United States
Yamaguchi University Hospital

Ube, Yamaguchi, Japan
Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

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