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

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: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: enzalutamide; Drug: abiraterone acetate; Drug: prednisone

Detailed Description

Subjects must continue on the treatment regimen that the subject was receiving in the prior study. Dose changes of any of the prior therapies subjects were receiving on the previous protocol are allowed after medical monitor approval. The day 1 visit for this study should coincide with the last treatment visit for the study the subject will be enrolling from (≤ 7 days post last visit of parent study). The subjects will be followed according to the local institution's standard of care and will be required to return to the institution every 24 weeks (± 7 days) to review adverse events (AEs), collect concomitant medications and confirm that no discontinuation criteria are met. At each visit and at every 12 weeks (IP only visit) subjects are to return all dispensed study drug and to receive more study drug if applicable. All AEs (new and ongoing from the study the subject is enrolling from) and Serious Adverse Events (SAEs) (including death), will be collected from the time the subject signs the consent form until the end of study visit.

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Astellas Pharma Global Development; Phone Number: 800-888-7704; Email: astellas.registration@astellas.com

Study Locations

• Argentina
  • Cordorba, Argentina
    • Completed
    • Site AR54003
  • San Miguel de Tucuman, Argentina, T4000IAK
    • Recruiting
    • Site AR54006
  • Tucuman, Argentina
    • Active, not recruiting
    • Site AR54002
  • Caba
    • Buenos Aires, Caba, Argentina, C1120AAT
      • Recruiting
      • Site AR54005
  • Santa Fé
    • Rosario, Santa Fé, Argentina, S2000DSV
      • Recruiting
      • Site AR54007
• Australia
  • Ashford, Australia
    • Active, not recruiting
    • Site AU61006
  • Ballarat, Australia, 3350
    • Recruiting
    • Site AU61019
  • East Bentleigh, Australia, 3165
    • Recruiting
    • Site AU61007
  • Malvern, Australia
    • Completed
    • Site AU61009
  • Parkville, Australia
    • Recruiting
    • Site AU61021
  • South Brisbane, Australia
    • Completed
    • Site AU61008
  • St Albans, Australia, 3021
    • Recruiting
    • Site AU61016
  • Westmead, Australia, 2145
    • Recruiting
    • Site AU61004
  • Westmead, Australia
    • Completed
    • Site AU61004
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Completed
      • Site AU61014
    • Tweed Heads, New South Wales, Australia, 2485
      • Completed
      • Site AU61001
    • Wahroonga, New South Wales, Australia, 2076
      • Recruiting
      • Site AU61017
• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Site AT43001
• Belgium
  • Anderlecht, Belgium, 1070
    • Recruiting
    • Site BE32009
  • Brussels, Belgium, B-1090
    • Active, not recruiting
    • Site BE32004
  • Gent, Belgium, 9000
    • Withdrawn
    • Site BE32005
  • Gent, Belgium, 9000
    • Recruiting
    • Site BE32011
  • Hasselt, Belgium
    • Completed
    • Site BE32007
  • Leuven, Belgium, 3000
    • Active, not recruiting
    • Site BE32008
  • Liege, Belgium, 4000
    • Active, not recruiting
    • Site BE32001
  • Turnhout, Belgium, 2300
    • Completed
    • Site BE32003
  • West-Vlaanderen
    • Kortrijk, West-Vlaanderen, Belgium, 8500
      • Active, not recruiting
      • Site BE32002
• Brazil
  • Bahia, Brazil, 41253-190
    • Recruiting
    • Site BR55009
  • Campinas, Brazil
    • Recruiting
    • Site BR55008
  • Ijuí, Brazil, 98700-000
    • Recruiting
    • Site BR55004
  • Jau, Brazil
    • Recruiting
    • Site BR55011
  • Rio Grande Do Sul, Brazil, 90610-000
    • Recruiting
    • Site BR55002
  • Santo Andre, Brazil, 09060-650
    • Recruiting
    • Site BR55010
  • RIO Grande DO SUL
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90430-090
      • Recruiting
      • Site BR55007
• Canada
  • Abbotsford, Canada, V2S 3N5
    • Recruiting
    • Site CA15019
  • Greenville, Canada, L6R 3J7 27834
    • Recruiting
    • Site CA15020
  • Montreal, Canada
    • Active, not recruiting
    • Site CA15011
  • Oakville, Canada, L6H 3P1
    • Recruiting
    • Site CA15017
  • Quebec, Canada, QC / G1S 4L8
    • Recruiting
    • Site CA15022
  • Ontario
    • Kingston, Ontario, Canada, K7L 3J7
      • Completed
      • Site CA15003
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Site CA15021
  • Quebec
    • Granby, Quebec, Canada, J2G 8Z9
      • Terminated
      • Site CA15001
• Chile
  • IX Region, Chile
    • Active, not recruiting
    • Site CL56004
  • Santiago, Chile
    • Completed
    • Site CL56002
  • Vina del Mar, Chile
    • Active, not recruiting
    • Site CL56001
  • RM
    • Santiago, RM, Chile, 7500787
      • Recruiting
      • Site CL56007
    • Santiago, RM, Chile, 75009
      • Recruiting
      • Site CL56005
  • Valparaiso
    • Vina Del Mar, Valparaiso, Chile, 2520598
      • Recruiting
      • Site CL56006
• Czechia
  • Olomouc, Czechia, 779 00
    • Active, not recruiting
    • Site CZ42002
  • Olomouc, Czechia, 775 20
    • Recruiting
    • Site CZ42004
  • Praha 2, Czechia
    • Completed
    • Site CZ42003
  • Praha 6, Czechia, 16000
    • Active, not recruiting
    • Site CZ42001
• Denmark
  • Aarhus, Denmark, 8200
    • Active, not recruiting
    • Site DK45003
  • Copenhagen, Denmark, 2100
    • Active, not recruiting
    • Site DK45001
  • Herlev, Denmark, 2730
    • Active, not recruiting
    • Site DK45004
  • Vejle, Denmark, 7100
    • Recruiting
    • Site DK45006
  • Nordjylland
    • Aalborg, Nordjylland, Denmark, 9000
      • Active, not recruiting
      • Site DK45002
• Finland
  • Tampere, Finland
    • Active, not recruiting
    • Site FL35802
  • Turku, Finland, 20521
    • Recruiting
    • Site FL35805
• France
  • La Roche sur Yon, France, 85925
    • Recruiting
    • Site FR33008
  • Lille, France, 59037
    • Completed
    • Site FR33010
  • Lyon Cedex 3, France, 69003
    • Active, not recruiting
    • Site FR33002
  • Montpellier Cedex, France, 34298
    • Recruiting
    • Site FR33020
  • Nimes, France, 30029
    • Completed
    • Site FR33006
  • Paris, France
    • Completed
    • Site FR33003
  • Paris, France
    • Completed
    • Site FR33017
  • Saint Herblain, France
    • Completed
    • Site FR33001
  • Strasbourg, France, 67000
    • Recruiting
    • Site FR33019
  • Strasbourg, France, 67098
    • Recruiting
    • Site FR33022
  • Villejuif, France
    • Active, not recruiting
    • Site FR33004
• Georgia
  • Tbilisi, Georgia, GE- 0186
    • Completed
    • Site GE99501
• Germany
  • Bonn, Germany, 53111
    • Active, not recruiting
    • Site DE49010
  • Hamburg, Germany, 22081
    • Active, not recruiting
    • Site DE49003
  • Hamburg, Germany
    • Completed
    • Site DE49013
  • Baden-Württemberg
    • Nürtingen, Baden-Württemberg, Germany, 72622
      • Recruiting
      • Site DE49004
    • Waldshut-Tiengen, Baden-Württemberg, Germany, 79761
      • Completed
      • Site DE49007
  • DE
    • Mannheim, DE, Germany, 68167
      • Active, not recruiting
      • Site DE49006
  • NRW
    • Duisburg, NRW, Germany, 47179
      • Completed
      • Site DE49001
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Site HK85202
• Israel
  • Peth Tikva, Israel
    • Completed
    • Site IL97202
  • Ramat-Gan, Israel
    • Completed
    • Site IL97204
  • Tzrifin Beer Yakov, Israel
    • Completed
    • Site IL97203
• Italy
  • Arezzo, Italy
    • Completed
    • Site IT39001
  • Candiolo, Italy
    • Recruiting
    • Site IT39011
  • Cremona, Italy
    • Active, not recruiting
    • Site IT39004
  • Forli, Italy
    • Completed
    • Site IT39002
  • Roma, Italy
    • Completed
    • Site IT39005
  • Trento, Italy, 38122
    • Recruiting
    • Site IT39006
  • Emilia Romagna
    • Faenza (RA), Emilia Romagna, Italy, 48018
      • Recruiting
      • Site IT39008
• Japan
  • Chiba, Japan, 260-8717
    • Active, not recruiting
    • Chiba Cancer Center
  • Fukuoka, Japan, 812-0033
    • Active, not recruiting
    • Harasanshin hospital
  • Kyoto, Japan, 606-8507
    • Active, not recruiting
    • Kyoto University Hospital
  • Niigata, Japan, 951-8520
    • Active, not recruiting
    • Niigata University Medical and Dental Hospital
  • Osaka, Japan
    • Active, not recruiting
    • Osaka Metropolitan University Hospital
  • Chiba
    • Sakura-shi, Chiba, Japan
      • Active, not recruiting
      • Toho University Sakura Medical Center
  • Fukuoka
    • Higashi-ku, Fukuoka, Japan
      • Completed
      • Kyushu University Hospital
  • Gunma
    • Maebashi-shi, Gunma, Japan
      • Active, not recruiting
      • Gunma University Hospital
  • Kagawa
    • Kida-gun, Kagawa, Japan
      • Recruiting
      • Kagawa University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 232-0024
      • Active, not recruiting
      • Yokohama City University Medical Center
  • Osaka
    • Sayama, Osaka, Japan, 589-8511
      • Active, not recruiting
      • Kindai University Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan
      • Active, not recruiting
      • Nippon Medical School Hospital
    • Koutou-ku, Tokyo, Japan
      • Completed
      • The Cancer Institute Hospital of Japanese Foundation For Cancer Research
  • Yamaguchi
    • Ube, Yamaguchi, Japan
      • Active, not recruiting
      • Yamaguchi University Hospital
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Recruiting
    • Site KR82008
  • Seongnam-si, Korea, Republic of
    • Completed
    • Site KR82005
  • Seongnam-si, Korea, Republic of, 013620
    • Recruiting
    • Site KR82012
  • Seoul, Korea, Republic of
    • Recruiting
    • Site KR82001
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Site KR82007
  • Seoul, Korea, Republic of
    • Recruiting
    • Site KR82002
  • Seoul, Korea, Republic of
    • Completed
    • Site KR82003
  • Seoul, Korea, Republic of
    • Completed
    • Site KR82004
  • Seoul, Korea, Republic of, 138-736
    • Recruiting
    • Site KR82011
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Site KR82009
• Malaysia
  • Kuching, Malaysia, 93586
    • Recruiting
    • Site MY60001
• Moldova, Republic of
  • Chisinau, Moldova, Republic of
    • Recruiting
    • Site MD37301
• Netherlands
  • Den Helder, Netherlands
    • Recruiting
    • Site NL31009
  • Maastricht, Netherlands, 6229
    • Recruiting
    • Site NL31004
  • Rotterdam, Netherlands, 3045 PM
    • Recruiting
    • Site NL31011
• New Zealand
  • Auckland, New Zealand, V2S 3N5
    • Recruiting
    • Site NZ64002
  • Dunedin, New Zealand, 9016
    • Recruiting
    • Site NZ64005
  • Hamilton, New Zealand
    • Active, not recruiting
    • Site NZ64001
• Norway
  • Stavanger, Norway
    • Recruiting
    • Site NO47001
• Poland
  • Gdansk, Poland
    • Active, not recruiting
    • Site PL48002
  • Myslowice, Poland
    • Active, not recruiting
    • Site PL48001
  • Pozman, Poland
    • Completed
    • Site PL48004
  • Slupsk, Poland, 76-200
    • Recruiting
    • Site PL48005
  • Wrocław, Poland, 54-144
    • Recruiting
    • Site PL48003
• Romania
  • Bucuresti, Romania, 50659
    • Recruiting
    • Site RO40003
• Russian Federation
  • Moscow, Russian Federation
    • Completed
    • Site RU70001
  • Moscow, Russian Federation, 125284
    • Recruiting
    • Site RU70001
  • St. Petersburg, Russian Federation
    • Active, not recruiting
    • Site RU70003
• Serbia
  • Belgrade, Serbia, 11040
    • Recruiting
    • Site RS38102
  • Belgrade, Serbia, 11080
    • Recruiting
    • Site RS38101
• Slovakia
  • Bratislava, Slovakia
    • Active, not recruiting
    • Site SK10223
  • Kosice, Slovakia, 04001
    • Recruiting
    • Site SK42109
  • Kosice, Slovakia, 04191
    • Completed
    • Site SK42106
  • Nitra, Slovakia, 949 01
    • Recruiting
    • Site SK42105
  • Presov, Slovakia, 080 01
    • Recruiting
    • Site SK42103
  • Trencin, Slovakia, 91101
    • Recruiting
    • Site SK42108
  • Zilina, Slovakia
    • Recruiting
    • Site SK42107
• South Africa
  • George, South Africa, 6529
    • Completed
    • Site ZA27001
• Spain
  • Barcelona, Spain
    • Active, not recruiting
    • Site ES34003
  • Barcelona, Spain
    • Withdrawn
    • Site ES34004
  • Barcelona, Spain, 08036
    • Recruiting
    • Site ES34007
  • Gerona, Spain, 17007
    • Completed
    • Site ES34011
  • Madrid, Spain, 28034
    • Completed
    • Site ES34001
  • Madrid, Spain, 28006
    • Recruiting
    • Site ES34012
  • Madrid, Spain
    • Recruiting
    • Site ES34008
  • Pamplona, Spain
    • Completed
    • Site ES34005
  • Santiago de Compostela, Spain, 15706
    • Recruiting
    • Site ES34010
• Sweden
  • Göteborg, Sweden, 41345
    • Active, not recruiting
    • Site SE46001
  • Umeå, Sweden, 90185
    • Active, not recruiting
    • Site SE46003
• Taiwan
  • Gueishan, Taiwan, 33305
    • Recruiting
    • Site TW88607
  • Kaohsiung, Taiwan, 81362
    • Recruiting
    • Site TW88603
  • Kaohsiung, Taiwan
    • Recruiting
    • Site TW88601
  • Taichung, Taiwan, 40447
    • Recruiting
    • Site TW88602
  • Taipei, Taiwan, 10002
    • Recruiting
    • Site TW88606
• Thailand
  • Bangkok, Thailand, 10330
    • Completed
    • Site TH66002
  • Songkla
    • Hat Yai, Songkla, Thailand, 90110
      • Recruiting
      • Site TH66001
• Turkey
  • Ankara
    • Besevler, Ankara, Turkey, 06500
      • Recruiting
      • Site TR90002
• United Kingdom
  • Bebington, United Kingdom
    • Completed
    • Site GB44009
  • Belfast, United Kingdom
    • Completed
    • Site GB44003
  • Bristol, United Kingdom, BS28HW
    • Completed
    • Site GB44004
  • Cambridge, United Kingdom
    • Recruiting
    • Site GB44014
  • Cardiff, United Kingdom, CF4 4XN
    • Active, not recruiting
    • Site GB44005
  • Glasgow, United Kingdom
    • Completed
    • Site GB44002
  • London, United Kingdom
    • Active, not recruiting
    • Site GB44006
  • Manchester, United Kingdom, M20 4BX
    • Active, not recruiting
    • Site GB44007
  • Northwood, United Kingdom
    • Completed
    • Site GB44008
  • Nottingham, United Kingdom, NG5 1PB
    • Recruiting
    • Site GB44016
  • Sutton, United Kingdom
    • Active, not recruiting
    • Site GB44001
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99503
      • Completed
      • Site US10052
  • Arizona
    • Tucson, Arizona, United States, 85741
      • Active, not recruiting
      • Site US10011
  • California
    • Los Angeles, California, United States, 90048
      • Completed
      • Site US10009
    • Los Angeles, California, United States, 90024
      • Completed
      • Site US10040
    • Orange, California, United States, 92868
      • Recruiting
      • Site US10067
    • San Bernardino, California, United States, 92404
      • Completed
      • Site US10008
    • San Diego, California, United States, 92108
      • Active, not recruiting
      • Site US10042
    • Stanford, California, United States, 94305
      • Completed
      • Site US10028
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Active, not recruiting
      • Site US10001
    • Denver, Colorado, United States, 80211
      • Completed
      • Site US10017
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Completed
      • Site US10050
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Completed
      • Site US10049
    • Jacksonville, Florida, United States, 32216
      • Withdrawn
      • Site US10048
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Active, not recruiting
      • Site US10002
    • Springfield, Illinois, United States, 62701
      • Recruiting
      • Springfield Clinic, LLP
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • Completed
      • Site US10007
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
    • Lenexa, Kansas, United States, 66214-1656
      • Recruiting
      • Site US10066
  • Maryland
    • Towson, Maryland, United States, 21204
      • Completed
      • Site US10029
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Completed
      • Site US10032
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Active, not recruiting
      • Site US10023
    • Omaha, Nebraska, United States, 68114
      • Recruiting
      • Nebraska Medical Hospital
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Active, not recruiting
      • Site US10004
  • New York
    • Garden City, New York, United States, 11530
      • Active, not recruiting
      • Site US10024
    • New York, New York, United States, 10065
      • Completed
      • Site US10055
    • New York, New York, United States, 10065
      • Completed
      • Site US10059
    • Poughkeepsie, New York, United States, 12601
      • Recruiting
      • Hudson Valley Urology, PC
    • Syracuse, New York, United States, 13210
      • Completed
      • Site US10053
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Completed
      • Site US10030
    • Charlotte, North Carolina, United States, 28207
      • Active, not recruiting
      • Site US10062
    • Concord, North Carolina, United States, 28025
      • Withdrawn
      • Site US10020
    • Greensboro, North Carolina, United States, 27403
      • Terminated
      • Site US10031
    • Greenville, North Carolina, United States, 27834
      • Recruiting
      • Eastern Urological Associates
    • Winston-Salem, North Carolina, United States, 27157
      • Completed
      • Site US10046
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Completed
      • Site US10035
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Completed
      • Site US10022
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Active, not recruiting
      • Site US10027
    • Pittsburgh, Pennsylvania, United States, 15232
      • Active, not recruiting
      • Site US10005
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Active, not recruiting
      • Site US10018
    • Myrtle Beach, South Carolina, United States, 29572
      • Recruiting
      • Carolina Urologic Research Center
    • Myrtle Beach, South Carolina, United States, 29572
      • Withdrawn
      • Site US10003
  • Tennessee
    • Nashville, Tennessee, United States, 37232-2765
      • Recruiting
      • Site US10041
  • Texas
    • Dallas, Texas, United States, 75231
      • Active, not recruiting
      • Site US10010
    • Houston, Texas, United States, 77024
      • Completed
      • Site US10034
    • Houston, Texas, United States, 77030
      • Active, not recruiting
      • Site US10043
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Completed
      • Site US10014
    • Virginia Beach, Virginia, United States, 23462
      • Active, not recruiting
      • Site US10015
  • Washington
    • Seattle, Washington, United States, 98101
      • Recruiting
      • Virginia Mason Medical Center
    • Seattle, Washington, United States, 98109
      • Active, not recruiting
      • Site US10038
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Active, not recruiting
      • Site US10021

Participation 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 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 the subject was receiving 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: enzalutamide; Subjects will receive enzalutamide orally once daily at the same time each day	Drug: enzalutamide; Subjects will receive enzalutamide orally once daily at the same time each day.; Other Names: Xtandi; MDV3100
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	Drug: enzalutamide; Subjects will receive enzalutamide orally once daily at the same time each day.; Other Names: Xtandi; MDV3100; Drug: abiraterone acetate; 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; Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	Until End of Study (Up to 96 Months)

Collaborators and Investigators

• Sponsor: Astellas Pharma Global Development, Inc.
• Collaborators: Pfizer
• Investigators: Study Director: Associate Medical Director, Astellas Pharma Global Development, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2016
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 7, 2016
• First Posted (Estimated): November 9, 2016

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: prostate cancer; Xtandi; MDV3100; enzalutamide; abiraterone acetate; prednisone
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Prednisone; Abiraterone Acetate
• Other Study ID Numbers: 9785-CL-0123; 2016-001694-32 (EudraCT Number); jRCT2031220674 (Other 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 compounds 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. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
• 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