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NCT04108208CompletedPhase 4

A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IV Study of Apalutamide in Chinese Participants With Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC)

Source: ClinicalTrials.gov · Last updated 30 Jul 2026

Brief summary (registry, in English)

The purpose of this study is to compare the improvement in time to prostate specific antigen (PSA) progression (TTPP, as defined by Prostate Cancer Working Group 2 \[PCWG2\]) of apalutamide versus placebo in Chinese participants with high-risk non-metastatic castration resistant prostate cancer (NM-CRPC).

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
75 (actual)
First submitted
26 Sept 2019
Start date
17 Dec 2019
Primary completion date
1 Jun 2023
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT04108208

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 75
  • From 17 Dec 2019 to the primary completion date, 1 Jun 2023
  • 27 sites in 1 country
  • 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

  • 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)

Other illness

  • 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)

Who the study is looking for

  • 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

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

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cancer Hospital, Chinese Academy of Medical Sciences
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BeijingChinaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
Peking University People's Hospital
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BeijingChinaUnknown status
Beijing Friendship Hospital
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BeijingChinaUnknown status
Beijing Hospital
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BeijingChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
Sichuan Provincial Peoples Hospital
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ChengduChinaUnknown status
Chongqing University Cancer Hospital
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ChongqingChinaUnknown status
Fujian Medical University Union Hospital
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FuzhouChinaUnknown status
Guangzhou First Municipal People's Hospital
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GuangzhouChinaUnknown status
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
Zhejiang Provincial People's Hospital
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HangzhouChinaUnknown status
Zhejiang Cancer Hospital
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HangzhouChinaUnknown status
The First Affiliated Hospital Zhejiang University College of Medicine
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HangzhouChinaUnknown status
Nanjing Drum Tower hospital
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NanjingChinaUnknown status
The First Affiliated Hospital of Ningbo University
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NingboChinaUnknown status
Huashan Hospital, Fudan University
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ShanghaiChinaUnknown status
The Fifth People's Hospital of Shanghai, Fudan University
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ShanghaiChinaUnknown status
Renji Hospital, Shanghai Jiaotong University School of Medicine
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ShanghaiChinaUnknown status
Shanghai Zhongshan Hospital
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ShanghaiChinaUnknown status
Cancer hospital Fudan University
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ShanghaiChinaUnknown status
Huadong Hospital Affiliated to Fudan University
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ShanghaiChinaUnknown status
First Affiliated Hospital SooChow University
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SuzhouChinaUnknown status
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
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WuhanChinaUnknown status
Wuxi People's Hospital
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WuxiChinaUnknown status
The First Affiliated Hospital of Xian Jiaotong University
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Xi'anChinaUnknown status

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