Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT02960022

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Led by Astellas Pharma Global Development, Inc. · Updated on 2026-04-13

900

Participants Needed

241

Research Sites

657 weeks

Total Duration

On this page

Sponsors

A

Astellas Pharma Global Development, Inc.

Lead Sponsor

P

Pfizer

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Must currently be receiving or assigned to receive enzalutamide for prostate cancer in an Astellas or Medivation sponsored study and benefit from continued treatment
  • Able to continue the treatment regimen from the prior study or have medical monitor approval for changes
  • Able to swallow enzalutamide capsules and comply with study requirements
  • Subject and female partner of childbearing potential must use two forms of birth control, including one highly effective and one barrier method, during the study and for 3 months after final enzalutamide dose
  • Agree to avoid sperm donation during the study and for at least 3 months after final enzalutamide dose
  • Agree not to participate in another interventional study while on treatment
Not Eligible

You will not qualify if you...

  • Cancer progressed or discontinuation criteria met in the prior enzalutamide clinical study
  • Requires new systemic therapy for cancer other than palliative radiation
  • Plans to use investigational therapy other than enzalutamide
  • Currently participating in an investigator-initiated interventional trial receiving enzalutamide
  • Has any disease, infection, or condition that risks safety or complicates data interpretation in the investigator's opinion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
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Trial Site Locations

Total: 241 locations

1

Site US10052

Anchorage, Alaska, United States, 99503

Completed

2

Site US10011

Tucson, Arizona, United States, 85741

Completed

3

Site US10040

Los Angeles, California, United States, 90024

Completed

4

Site US10009

Los Angeles, California, United States, 90048

Completed

5

Site US10067

Orange, California, United States, 92868

Actively Recruiting

6

Site US10008

San Bernardino, California, United States, 92404

Completed

7

Site US10042

San Diego, California, United States, 92108

Completed

8

Site US10028

Stanford, California, United States, 94305

Completed

9

Site US10001

Aurora, Colorado, United States, 80045

Completed

10

Site US10017

Denver, Colorado, United States, 80211

Completed

11

Site US10050

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

Completed

12

Site US10049

Daytona Beach, Florida, United States, 32114

Completed

13

Site US10048

Jacksonville, Florida, United States, 32216

Withdrawn

14

Site US10002

Chicago, Illinois, United States, 60637

Active, Not Recruiting

15

Springfield Clinic, LLP

Springfield, Illinois, United States, 62701

Active, Not Recruiting

16

Site US10007

Jeffersonville, Indiana, United States, 47130

Completed

17

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Active, Not Recruiting

18

Site US10066

Lenexa, Kansas, United States, 66214-1656

Active, Not Recruiting

19

Site US10029

Towson, Maryland, United States, 21204

Completed

20

Site US10032

St Louis, Missouri, United States, 63110

Completed

21

Nebraska Medical Hospital

Omaha, Nebraska, United States, 68114

Active, Not Recruiting

22

Site US10023

Omaha, Nebraska, United States, 68130

Active, Not Recruiting

23

Site US10004

Hackensack, New Jersey, United States, 07601

Active, Not Recruiting

24

Site US10024

Garden City, New York, United States, 11530

Active, Not Recruiting

25

Site US10055

New York, New York, United States, 10065

Completed

26

Site US10059

New York, New York, United States, 10065

Completed

27

Hudson Valley Urology, PC

Poughkeepsie, New York, United States, 12601

Active, Not Recruiting

28

Site US10053

Syracuse, New York, United States, 13210

Completed

29

Site US10030

Chapel Hill, North Carolina, United States, 27599

Completed

30

Site US10062

Charlotte, North Carolina, United States, 28207

Active, Not Recruiting

31

Site US10020

Concord, North Carolina, United States, 28025

Withdrawn

32

Site US10031

Greensboro, North Carolina, United States, 27403

Terminated

33

Eastern Urological Associates

Greenville, North Carolina, United States, 27834

Completed

34

Site US10046

Winston-Salem, North Carolina, United States, 27157

Completed

35

Site US10035

Cincinnati, Ohio, United States, 45212

Completed

36

Site US10022

Springfield, Oregon, United States, 97477

Completed

37

Site US10027

Lancaster, Pennsylvania, United States, 17604

Completed

38

Site US10005

Pittsburgh, Pennsylvania, United States, 15232

Active, Not Recruiting

39

Site US10018

Charleston, South Carolina, United States, 29414

Active, Not Recruiting

40

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States, 29572

Active, Not Recruiting

41

Site US10003

Myrtle Beach, South Carolina, United States, 29572

Withdrawn

42

Site US10041

Nashville, Tennessee, United States, 37232-2765

Active, Not Recruiting

43

Site US10010

Dallas, Texas, United States, 75231

Active, Not Recruiting

44

Site US10034

Houston, Texas, United States, 77024

Completed

45

Site US10043

Houston, Texas, United States, 77030

Active, Not Recruiting

46

Site US10014

Norfolk, Virginia, United States, 23502

Completed

47

Site US10015

Virginia Beach, Virginia, United States, 23462

Active, Not Recruiting

48

Virginia Mason Medical Center

Seattle, Washington, United States, 98101

Active, Not Recruiting

49

Site US10038

Seattle, Washington, United States, 98109

Completed

50

Site US10021

Madison, Wisconsin, United States, 53792

Active, Not Recruiting

51

Site AR54005

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

Completed

52

Site AR54007

Rosario, Santa Fe Province, Argentina, S2000DSV

Active, Not Recruiting

53

Site AR54008

Buenos Aires, Argentina

Active, Not Recruiting

54

Site AR54003

Cordorba, Argentina

Completed

55

Site AR54006

San Miguel de Tucumán, Argentina, T4000IAK

Active, Not Recruiting

56

Site AR54002

San Miguel de Tucumán, Argentina

Completed

57

Site AU61014

Albury, New South Wales, Australia, 2640

Completed

58

Site AU61001

Tweed Heads, New South Wales, Australia, 2485

Completed

59

Site AU61012

Wahroonga, New South Wales, Australia, 2076

Completed

60

Site AU61017

Wahroonga, New South Wales, Australia, 2076

Active, Not Recruiting

61

Site AU61006

Ashford, Australia

Active, Not Recruiting

62

Site AU61019

Ballarat, Australia, 3350

Active, Not Recruiting

63

Site AU61007

East Bentleigh, Australia, 3165

Completed

64

Site AU61009

Malvern, Australia

Completed

65

Site AU61021

Parkville, Australia

Completed

66

Site AU61008

South Brisbane, Australia

Completed

67

Site AU61016

St Albans, Australia, 3021

Active, Not Recruiting

68

Site AU61004

Westmead, Australia, 2145

Active, Not Recruiting

69

Site AT43001

Vienna, Austria, 1090

Active, Not Recruiting

70

Site BE32002

Kortrijk, West-Vlaanderen, Belgium, 8500

Active, Not Recruiting

71

Site BE32009

Anderlecht, Belgium, 1070

Active, Not Recruiting

72

Site BE32004

Brussels, Belgium, B-1090

Active, Not Recruiting

73

Site BE32005

Ghent, Belgium, 9000

Active, Not Recruiting

74

Site BE32011

Ghent, Belgium, 9000

Active, Not Recruiting

75

Site BE32007

Hasselt, Belgium

Completed

76

Site BE32008

Leuven, Belgium, 3000

Completed

77

Site BE32001

Liège, Belgium, 4000

Completed

78

Site BE32003

Turnhout, Belgium, 2300

Completed

79

Site BR55007

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

Active, Not Recruiting

80

Site BR55009

Bahia, Brazil, 41253-190

Active, Not Recruiting

81

Site BR55008

Campinas, Brazil

Active, Not Recruiting

82

Site BR55004

Ijuí, Brazil, 98700-000

Actively Recruiting

83

Site BR55011

Jaú, Brazil

Active, Not Recruiting

84

Site BR55002

Rio Grande, Brazil, 90610-000

Active, Not Recruiting

85

Site BR55010

Santo André, Brazil, 09060-650

Active, Not Recruiting

86

Site CA15003

Kingston, Ontario, Canada, K7L 3J7

Completed

87

Site CA15021

Toronto, Ontario, Canada, M4N 3M5

Active, Not Recruiting

88

Site CA15001

Granby, Quebec, Canada, J2G 8Z9

Terminated

89

Site CA15019

Abbotsford British Columbia, Canada, V2S 3N5

Active, Not Recruiting

90

Site CA15020

Greenville, Canada, L6R 3J7 27834

Active, Not Recruiting

91

Site CA15011

Montreal, Canada

Active, Not Recruiting

92

Site CA15017

Oakville, Canada, L6H 3P1

Active, Not Recruiting

93

Site CA15022

Québec, Canada, QC / G1S 4L8

Active, Not Recruiting

94

Site CL56007

Santiago, RM, Chile, 7500787

Active, Not Recruiting

95

Site CL56005

Santiago, RM, Chile, 75009

Active, Not Recruiting

96

Site CL56006

Viña del Mar, Valparaiso, Chile, 2520598

Active, Not Recruiting

97

Site CL56004

IX Region, Chile

Active, Not Recruiting

98

Site CL56002

Santiago, Chile

Completed

99

Site CL56001

Viña del Mar, Chile

Active, Not Recruiting

100

Site CN86003

Hubei, China, 430030

Active, Not Recruiting

101

Site CN86010

Hunan, China, 410013

Active, Not Recruiting

102

Site CN86005

Nanjing, China

Active, Not Recruiting

103

Site CZ42004

Olomouc, Czechia, 775 20

Active, Not Recruiting

104

Site CZ42002

Olomouc, Czechia, 779 00

Active, Not Recruiting

105

Site CZ42001

Prague, Czechia, 16000

Completed

106

Site CZ42003

Prague, Czechia

Completed

107

Site DK45002

Aalborg, North Denmark, Denmark, 9000

Active, Not Recruiting

108

Site DK45003

Aarhus, Denmark, 8200

Active, Not Recruiting

109

Site DK45001

Copenhagen, Denmark, 2100

Completed

110

Site DK45004

Herlev, Denmark, 2730

Active, Not Recruiting

111

Site DK45006

Vejle, Denmark, 7100

Completed

112

Site FL35802

Tampere, Finland

Active, Not Recruiting

113

Site FL35805

Turku, Finland, 20521

Active, Not Recruiting

114

Site FR33021

Bordeaux, France, 33076

Completed

115

Site FR33008

La Roche-sur-Yon, France, 85925

Completed

116

Site FR33010

Lille, France, 59037

Completed

117

Site FR33002

Lyon, France, 69003

Completed

118

Site FR33020

Montpellier, France, 34298

Completed

119

Site FR33006

Nîmes, France, 30029

Completed

120

Site FR33003

Paris, France

Completed

121

Site FR33017

Paris, France

Completed

122

Site FR33001

Saint-Herblain, France

Completed

123

Site FR33019

Strasbourg, France, 67000

Completed

124

Site FR33022

Strasbourg, France, 67098

Completed

125

Site FR33004

Villejuif, France

Completed

126

Site GE99501

Tbilisi, Georgia, GE- 0186

Completed

127

Site DE49004

Nürtingen, Baden-Wurttemberg, Germany, 72622

Completed

128

Site DE49007

Waldshut-Tiengen, Baden-Wurttemberg, Germany, 79761

Completed

129

Site DE49006

Mannheim, DE, Germany, 68167

Active, Not Recruiting

130

Site DE49001

Duisburg, North Rhine-Westphalia, Germany, 47179

Completed

131

Site DE49010

Bonn, Germany, 53111

Active, Not Recruiting

132

Site DE49003

Hamburg, Germany, 22081

Active, Not Recruiting

133

Site DE49013

Hamburg, Germany

Completed

134

Site HK85202

Hong Kong, Hong Kong

Active, Not Recruiting

135

Site IL97206

Haifa, Israel, 3109601

Actively Recruiting

136

Site IL97205

Jerusalem, Israel

Active, Not Recruiting

137

Site IL97202

Peth Tikva, Israel

Completed

138

Site IL97204

Ramat Gan, Israel

Completed

139

Site IL97203

Tzrifin Beer Yakov, Israel

Completed

140

Site IT39008

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

Active, Not Recruiting

141

Site IT39001

Arezzo, Italy

Completed

142

Site IT39011

Candiolo, Italy

Active, Not Recruiting

143

Site IT39004

Cremona, Italy

Active, Not Recruiting

144

Site IT39002

Forlì, Italy

Completed

145

Site IT39005

Roma, Italy

Completed

146

Site IT39009

Toscana, Italy

Active, Not Recruiting

147

Site IT39006

Trento, Italy, 38122

Active, Not Recruiting

148

Toho University Sakura Medical Center

Sakura-shi, Chiba, Japan

Active, Not Recruiting

149

Kyushu University Hospital

Higashiku, Fukuoka, Japan

Completed

150

Gunma University Hospital

Maebashi, Gunma, Japan

Active, Not Recruiting

151

Kagawa University Hospital

Kida-gun, Kagawa-ken, Japan

Active, Not Recruiting

152

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan, 232-0024

Active, Not Recruiting

153

Kindai University Hospital

Sayama, Osaka, Japan, 589-8511

Active, Not Recruiting

154

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, Japan

Active, Not Recruiting

155

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koutou-ku, Tokyo, Japan

Completed

156

Yamaguchi University Hospital

Ube, Yamaguchi, Japan

Active, Not Recruiting

157

Chiba cancer center

Chiba, Japan, 260-8717

Active, Not Recruiting

158

Harasanshin hospital

Fukuoka, Japan, 812-0033

Active, Not Recruiting

159

Kyoto University hospital

Kyoto, Japan, 606-8507

Active, Not Recruiting

160

Niigata University Medical and Dental Hospital

Niigata, Japan, 951-8520

Completed

161

Osaka Metropolitan University Hospital

Osaka, Japan

Active, Not Recruiting

162

Site MY60001

Kuching, Malaysia, 93586

Completed

163

Site MD37301

Chisinau, Moldova

Active, Not Recruiting

164

Site NL31010

Amsterdam, Netherlands, 1066 CX

Active, Not Recruiting

165

Site NL31009

Den Helder, Netherlands

Active, Not Recruiting

166

Site NL31004

Maastricht, Netherlands, 6229

Active, Not Recruiting

167

Site NL31011

Rotterdam, Netherlands, 3045 PM

Active, Not Recruiting

168

Site NZ64002

Auckland, New Zealand, V2S 3N5

Active, Not Recruiting

169

Site NZ64005

Dunedin, New Zealand, 9016

Active, Not Recruiting

170

Site NZ64001

Hamilton, New Zealand

Active, Not Recruiting

171

Site NO47001

Stavanger, Norway

Active, Not Recruiting

172

Site PL48002

Gdansk, Poland

Active, Not Recruiting

173

Site PL48001

Mysłowice, Poland

Active, Not Recruiting

174

Site PL48004

Pozman, Poland

Completed

175

Site PL48005

Słupsk, Poland, 76-200

Active, Not Recruiting

176

Site PL48011

Warsaw, Poland, 04-073

Active, Not Recruiting

177

Site PL48003

Wroclaw, Poland, 54-144

Active, Not Recruiting

178

Site RO40003

Bucharest, Romania, 50659

Active, Not Recruiting

179

Site RO40001

Cluj-Napoca, Romania, 400015

Active, Not Recruiting

180

Site RO40004

Cluj-Napoca, Romania, 400015

Active, Not Recruiting

181

Site RU70008

Ivanovo, Russia, 153040

Active, Not Recruiting

182

Site RU70001

Moscow, Russia, 125284

Active, Not Recruiting

183

Site RU70005

Omsk, Russia

Active, Not Recruiting

184

Site RU70009

Saint Petersburg, Russia, 191104

Active, Not Recruiting

185

Site RU70003

Saint Petersburg, Russia

Active, Not Recruiting

186

Site RU70006

Saint Petersburg, Russia

Active, Not Recruiting

187

Site RS38102

Belgrade, Serbia, 11040

Completed

188

Site RS38101

Belgrade, Serbia, 11080

Active, Not Recruiting

189

Site SK10223

Bratislava, Slovakia

Active, Not Recruiting

190

Site SK42109

Košice, Slovakia, 04001

Active, Not Recruiting

191

Site SK42106

Košice, Slovakia, 04191

Completed

192

Site SK42105

Nitra, Slovakia, 949 01

Active, Not Recruiting

193

Site SK42103

Prešov, Slovakia, 080 01

Active, Not Recruiting

194

Site SK42108

Trenčín, Slovakia, 91101

Active, Not Recruiting

195

Site SK42107

Žilina, Slovakia

Active, Not Recruiting

196

Site ZA27001

George, South Africa, 6529

Completed

197

Site KR82008

Busan, South Korea, 49241

Active, Not Recruiting

198

Site KR82012

Seongnam-si, South Korea, 013620

Active, Not Recruiting

199

Site KR82005

Seongnam-si, South Korea

Completed

200

Site KR82009

Seoul, South Korea, 03080

Active, Not Recruiting

201

Site KR82007

Seoul, South Korea, 06351

Active, Not Recruiting

202

Site KR82011

Seoul, South Korea, 138-736

Active, Not Recruiting

203

Site KR82001

Seoul, South Korea

Active, Not Recruiting

204

Site KR82002

Seoul, South Korea

Active, Not Recruiting

205

Site KR82003

Seoul, South Korea

Completed

206

Site KR82004

Seoul, South Korea

Completed

207

Site ES34007

Barcelona, Spain, 08036

Completed

208

Site ES34003

Barcelona, Spain

Active, Not Recruiting

209

Site ES34004

Barcelona, Spain

Withdrawn

210

Site ES34011

Girona, Spain, 17007

Completed

211

Site ES34012

Madrid, Spain, 28006

Completed

212

Site ES34001

Madrid, Spain, 28034

Completed

213

Site ES34008

Madrid, Spain

Active, Not Recruiting

214

Site ES34005

Pamplona, Spain

Completed

215

Site ES34014

Salamanca, Spain

Active, Not Recruiting

216

Site ES34010

Santiago de Compostela, Spain, 15706

Active, Not Recruiting

217

Site SE46001

Gothenburg, Sweden, 41345

Completed

218

Site SE46003

Umeå, Sweden, 90185

Active, Not Recruiting

219

Site TW88607

Guishan, Taiwan, 33305

Active, Not Recruiting

220

Site TW88603

Kaohsiung City, Taiwan, 81362

Active, Not Recruiting

221

Site TW88601

Kaohsiung City, Taiwan

Completed

222

Site TW88602

Taichung, Taiwan, 40447

Active, Not Recruiting

223

Site TW88606

Taipei, Taiwan, 10002

Active, Not Recruiting

224

Site TH66001

Hat Yai, Changwat Songkhla, Thailand, 90110

Active, Not Recruiting

225

Site TH66002

Bangkok, Thailand, 10330

Completed

226

Site TR90002

Beşevler, Ankara, Turkey (Türkiye), 06500

Active, Not Recruiting

227

Site UA38004

Dnipro, Ukraine, 49005

Active, Not Recruiting

228

Site UA38005

Kharkiv, Ukraine, 61037

Active, Not Recruiting

229

Site UA38001

Kyiv, Ukraine, 02125

Active, Not Recruiting

230

Site UA38003

Uzhhorod, Ukraine, 88000

Active, Not Recruiting

231

Site GB44009

Bebington, United Kingdom

Completed

232

Site GB44003

Belfast, United Kingdom

Completed

233

Site GB44004

Bristol, United Kingdom, BS28HW

Completed

234

Site GB44014

Cambridge, United Kingdom

Active, Not Recruiting

235

Site GB44005

Cardiff, United Kingdom, CF4 4XN

Active, Not Recruiting

236

Site GB44002

Glasgow, United Kingdom

Completed

237

Site GB44006

London, United Kingdom

Active, Not Recruiting

238

Site GB44007

Manchester, United Kingdom, M20 4BX

Active, Not Recruiting

239

Site GB44008

Northwood, United Kingdom

Completed

240

Site GB44016

Nottingham, United Kingdom, NG5 1PB

Active, Not Recruiting

241

Site GB44001

Sutton, United Kingdom

Active, Not Recruiting

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Research Team

A

Astellas Pharma Global Development

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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