Loading clinical trials...

A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE4

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)

NCT04108208•Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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)

Locations (27)

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

Key Dates

Start Date

December 17, 2019

Primary Completion Date

June 1, 2023

Completion Date

June 5, 2026

Last Updated

March 16, 2026

Enrollment

ACTUAL participants

Conditions

Prostatic Neoplasms

Interventions

Apalutamide

DRUG

Placebo

DRUG

Androgen-deprivation Therapy (ADT)

DRUG

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT07225946

Prostatic Neoplasms, Castration-Resistant

View study

RECRUITINGPHASE1/PHASE2

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

NCT04868604

Prostatic Neoplasms, Castration-Resistant

View study

RECRUITING

Prostate Active Surveillance Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

Prostate Active Surveillance Study

Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer

A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas

Clinical Application of the J-PET Scanner Prototype