A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)
NCT ID: NCT04108208
Last Updated: 2025-11-13
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE4
75 participants
INTERVENTIONAL
2019-12-17
2026-06-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Apalutamide 240 milligram (mg) plus ADT
Participants will receive apalutamide 240 mg orally daily from Day 1 of Cycle 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study along with androgen-deprivation therapy (ADT). Each treatment cycle will consist of 28 days.
Apalutamide
Apalutamide 240 mg (4\*60 mg tablets) will be administrated orally once daily.
Androgen-deprivation Therapy (ADT)
Participants will continue to receive ADT with gonadotrophin-releasing hormone agonists (GnRHa) who have not been surgically castrated.
Placebo plus ADT
Participants will receive matching placebo daily along with ADT from Cycle 1 Day 1 until disease progression, unacceptable toxicity, withdrawal of consent, death or termination of the study. Participants who do not have distant metastasis will switch to treatment with apalutamide after completion of 5 cycles of placebo treatment. Participants who have prostate-specific antigen (PSA) progression prior to completion of 5 cycles of study treatment, will cross over to apalutamide at the time of PSA progression. Each treatment cycle will consist of 28 days.
Placebo
Matching placebo will be administered orally.
Androgen-deprivation Therapy (ADT)
Participants will continue to receive ADT with gonadotrophin-releasing hormone agonists (GnRHa) who have not been surgically castrated.
Interventions
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Apalutamide
Apalutamide 240 mg (4\*60 mg tablets) will be administrated orally once daily.
Placebo
Matching placebo will be administered orally.
Androgen-deprivation Therapy (ADT)
Participants will continue to receive ADT with gonadotrophin-releasing hormone agonists (GnRHa) who have not been surgically castrated.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
MALE
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, , China
Peking University First Hospital
Beijing, , China
Peking University People s Hospital
Beijing, , China
Beijing Friendship Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
Beijing Hospital
Beijing, , China
Hunan Cancer hospital
Changsha, , China
Sichuan Provincial Peoples Hospital
Chengdu, , China
Chongqing University Cancer Hospital
Chongqing, , China
Fujian Medical University Union Hospital
Fuzhou, , China
Sun Yat-Sen Memorial Hospital Sun Yat-sen University
Guangzhou, , China
Guangzhou First Municipal People's Hospital
Guangzhou, , China
Zhejiang Provincial People's Hospital
Hangzhou, , China
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Nanjing Drum Tower Hospital
Nanjing, , China
The First Affiliated Hospital of Ningbo University
Ningbo, , China
Cancer Hospital, FuDan University
Shanghai, , China
Shanghai Zhongshan Hospital
Shanghai, , China
Huashan Hospital Fudan University
Shanghai, , China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
The Fifth People's Hospital of Shanghai, Fudan University
Shanghai, , China
Huadong Hospital Affiliated to Fudan University
Shanghai, , China
First Affiliated Hospital SooChow University
Suzhou, , China
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
Wuhan, , China
Wuxi People s Hospital
Wuxi, , China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, , China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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56021927PCR4007
Identifier Type: OTHER
Identifier Source: secondary_id
CR108660
Identifier Type: -
Identifier Source: org_study_id