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Promising prostate cancer drug apalutamide tested in chinese patients

NCT ID NCT04108208

Disease control Sponsor: Janssen Research & Development, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tests whether the drug apalutamide can delay prostate cancer progression in Chinese men whose cancer has stopped responding to standard hormone therapy but hasn't spread to other parts of the body. About 75 participants will receive either apalutamide or a placebo, alongside ongoing hormone therapy. The main goal is to see how long it takes for a key cancer marker (PSA) to rise, indicating progression.

What this could mean

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

Active substance
apalutamide
What this could lead to
If successful, this could provide a new treatment option for Chinese men with prostate cancer that has stopped responding to hormone therapy but hasn't spread, potentially delaying disease progression.
What could go wrong
This is a relatively small, early-stage trial (75 participants) focused on a biomarker (PSA) rather than survival or metastasis. The drug may not show meaningful benefit or could cause side effects like fatigue, falls, or fractures.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

75 people

The number who actually took part.

Started

Dec 2019

Finished

Jun 2026

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 or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features, with high risk for development of metastases, defined as prostate-specific antigen doubling time (PSADT) less than or equals to (\<=) 10 months. PSADT is calculated using at least 3 prostate-specific antigen (PSA) values obtained during continuous androgen deprivation therapy (ADT) * Castration-resistant prostate cancer (PC) demonstrated during continuous ADT, defined as 3 PSA rises at least 1 week apart, with the last PSA greater than (\>) 2 nanogram per milliliter (ng/mL) * Surgically or medically castrated, with testosterone levels of less than (\<) 50 nanogram per deciliter (ng/dL). If the participant is medically castrated, continuous dosing with gonadotropin releasing hormone analog (GnRHa) must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study to maintain castrate levels of testosterone * Participants who received a first-generation anti-androgen (example: bicalutamide, flutamide, nilutamide) must have at least a 4-week washout prior to randomization and must show continuing disease progression (an increase in PSA) after washout * At least 4 weeks must have elapsed from major surgery or radiation therapy prior to randomization Exclusion Criteria: * Presence of distant metastases, including central nervous system (CNS) and vertebral or meningeal involvement, or history of distant metastases. Exception: Pelvic lymph nodes \<2 centimeter in short axis (N1) located below the iliac bifurcation are allowed * Symptomatic loco-regional disease requiring medical intervention, such as moderate or severe urinary obstruction or hydronephrosis, due to primary tumor (example, tumor obstruction of bladder trigone) * Prior treatment with cytochrome P450 17 alpha-hydroxylase/17,20-lyase (CYP17) inhibitors (example: abiraterone acetate, orteronel, galerterone, ketoconazole, aminoglutethimide) for PC * Prior chemotherapy for PC, except if administered in the adjuvant/neoadjuvant setting * Prior treatment with second generation anti-androgens (example, enzalutamide) * History of seizure or condition that may pre-dispose to seizure (example: prior stroke within 1 year prior to randomization, brain arteriovenous malformation, schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma prostate cancer prostate neoplasm

As listed by the trial registrant

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

Prostatic neoplasms

Contacts and locations

Locations

  • Beijing Friendship Hospital

    Beijing, 100050, China

  • Beijing Hospital

    Beijing, 100730, China

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 100021, China

  • Cancer Hospital, FuDan University

    Shanghai, 200032, China

  • Chongqing University Cancer Hospital

    Chongqing, 400030, China

  • First Affiliated Hospital SooChow University

    Suzhou, 215006, China

  • Fujian Medical University Union Hospital

    Fuzhou, 350001, China

  • Guangzhou First Municipal People's Hospital

    Guangzhou, 510180, China

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, 200400, China

  • Huashan Hospital Fudan University

    Shanghai, 200040, China

  • Hunan Cancer hospital

    Changsha, 410013, China

  • Nanjing Drum Tower Hospital

    Nanjing, 210008, China

  • Peking University First Hospital

    Beijing, 100034, China

  • Peking University People's Hospital

    Beijing, 100044, China

  • Peking University Third Hospital

    Beijing, 100191, China

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200240, China

  • Shanghai Zhongshan Hospital

    Shanghai, 200032, China

  • Sichuan Provincial Peoples Hospital

    Chengdu, 610072, China

  • Sun Yat-Sen Memorial Hospital Sun Yat-sen University

    Guangzhou, 510120, China

  • The Fifth People's Hospital of Shanghai, Fudan University

    Shanghai, 200240, China

  • The First Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, 310003, China

  • The First Affiliated Hospital of Ningbo University

    Ningbo, 315010, China

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061, China

  • TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

    Wuhan, 430030, China

  • Wuxi People s Hospital

    Wuxi, 214023, China

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310000, China

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