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NCT02294461CompletedPhase 3

An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants

Asian Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral Enzalutamide in Chemotherapy Naïve Subjects With Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy

Source: ClinicalTrials.gov · Last updated 24 Oct 2025

Brief summary (registry, in English)

Purpose of the study was to assess the effect of enzalutamide on time to Prostate Specific Antigen (PSA) progression as compared to placebo in chemotherapy naïve participants with progressive metastatic prostate cancer who have failed androgen deprivation therapy.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
395 (actual)
First submitted
13 Nov 2014
Start date
23 Apr 2014
Primary completion date
20 Sept 2015
Lead sponsor
Astellas Pharma Inc
NCT number
NCT02294461

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 395
  • From 23 Apr 2014 to the primary completion date, 20 Sept 2015
  • 47 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
  • History of seizure including febrile seizure or any condition that may predispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization).

Other illness

  • Known or suspected brain metastasis or active leptomeningeal disease
  • History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer

Who the study is looking for

  • Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
  • Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy
  • Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bone disease
  • No prior treatment with cytotoxic chemotherapy
  • Asymptomatic or mildly symptomatic from prostate cancer

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (47)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
CN00127
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BeijingChinaUnknown status
CN00115
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BeijingChinaUnknown status
CN00114
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BeijingChinaUnknown status
CN00111
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BeijingChinaUnknown status
CN00103
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BeijingChinaUnknown status
CN00106
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BeijingChinaUnknown status
CN00104
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BeijingChinaUnknown status
CN00112
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BeijingChinaUnknown status
CN00121
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ChangshaChinaUnknown status
CN00107
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HangzhouChinaUnknown status
CN00110
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NanjingChinaUnknown status
CN00117
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NanjingChinaUnknown status
CN00108
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ShanghaiChinaUnknown status
CN00113
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ShanghaiChinaUnknown status
CN00102
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ShanghaiChinaUnknown status
CN00126
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ShanghaiChinaUnknown status
CN00105
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ShanghaiChinaUnknown status
CN00119
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SuzhouChinaUnknown status
CN00125
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TianjinChinaUnknown status
CN00118
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WenzhouChinaUnknown status
CN00109
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WuhanChinaUnknown status
CN00124
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Xi'anChinaUnknown status
HK00402
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Hong KongHong KongUnknown status
KR00214
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AnyangSouth KoreaUnknown status
KR00207
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BusanSouth KoreaUnknown status
KR00205
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BusanSouth KoreaUnknown status
KR00212
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Cheongju-siSouth KoreaUnknown status
KR00203
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DaeguSouth KoreaUnknown status
KR00213
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DaejeonSouth KoreaUnknown status
KR00201
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IncheonSouth KoreaUnknown status
KR00202
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Seongnam-siSouth KoreaUnknown status
KR00204
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SeoulSouth KoreaUnknown status
KR00215
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SeoulSouth KoreaUnknown status
KR00208
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SeoulSouth KoreaUnknown status
KR00209
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SeoulSouth KoreaUnknown status
KR00206
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SeoulSouth KoreaUnknown status
KR00210
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SeoulSouth KoreaUnknown status
KR00211
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SeoulSouth KoreaUnknown status
TW00309
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Kaohsiung CityTaiwanUnknown status
TW00303
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TaichungTaiwanUnknown status
TW00302
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TaichungTaiwanUnknown status
TW00308
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TainanTaiwanUnknown status
TW00307
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TainanTaiwanUnknown status
TW00306
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TaipeiTaiwanUnknown status
TW00304
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TaipeiTaiwanUnknown status
TW00301
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TaipeiTaiwanUnknown status
TW00305
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Taoyuan CountyTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.