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New hope for prostate cancer: enzalutamide slows progression in asian men

NCT ID NCT02294461

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tested the drug enzalutamide in 395 Asian men with metastatic prostate cancer that had stopped responding to standard hormone therapy. Participants had not yet received chemotherapy. The study compared enzalutamide to a placebo to see if it could delay rises in PSA levels, a marker of cancer progression. The goal was to assess whether enzalutamide could help control the disease for a longer time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
enzalutamide (Xtandi)
What this could lead to
If successful, enzalutamide could offer a new treatment option to delay cancer progression in men with metastatic prostate cancer who have not yet had chemotherapy.
What could go wrong
This trial is completed, but results may not apply to all populations. Enzalutamide can cause side effects like fatigue, high blood pressure, and falls. It controls the disease, not cures it.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

395 people

The number who actually took part.

Started

Apr 2014

Finished

Jul 2024

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: * 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 Exclusion Criteria: * Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment * 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 * 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).

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma Kennedy disease metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

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

Progressive metastatic prostate cancer

Contacts and locations

Locations

  • CN00102

    Shanghai, China

  • CN00103

    Beijing, China

  • CN00104

    Beijing, China

  • CN00105

    Shanghai, China

  • CN00106

    Beijing, China

  • CN00107

    Hangzhou, China

  • CN00108

    Shanghai, China

  • CN00109

    Wuhan, China

  • CN00110

    Nanjing, China

  • CN00111

    Beijing, China

  • CN00112

    Beijing, China

  • CN00113

    Shanghai, China

  • CN00114

    Beijing, China

  • CN00115

    Beijing, China

  • CN00117

    Nanjing, China

  • CN00118

    Wenzhou, China

  • CN00119

    Suzhou, China

  • CN00121

    Changsha, China

  • CN00124

    Xi'an, China

  • CN00125

    Tianjin, China

  • CN00126

    Shanghai, China

  • CN00127

    Beijing, China

  • HK00402

    Hong Kong, Hong Kong

  • KR00201

    Incheon, South Korea

  • KR00202

    Seongnam-si, South Korea

  • KR00203

    Daegu, South Korea

  • KR00204

    Seoul, South Korea

  • KR00205

    Busan, South Korea

  • KR00206

    Seoul, South Korea

  • KR00207

    Busan, South Korea

  • KR00208

    Seoul, South Korea

  • KR00209

    Seoul, South Korea

  • KR00210

    Seoul, South Korea

  • KR00211

    Seoul, South Korea

  • KR00212

    Cheongju-si, South Korea

  • KR00213

    Daejeon, South Korea

  • KR00214

    Anyang, South Korea

  • KR00215

    Seoul, South Korea

  • TW00301

    Taipei, Taiwan

  • TW00302

    Taichung, Taiwan

  • TW00303

    Taichung, Taiwan

  • TW00304

    Taipei, Taiwan

  • TW00305

    Taoyuan County, Taiwan

  • TW00306

    Taipei, Taiwan

  • TW00307

    Tainan, Taiwan

  • TW00308

    Tainan, Taiwan

  • TW00309

    Kaohsiung City, Taiwan

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