BENITIONSClinical Trial Intelligence

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

4期 已完成 NCT04108208

适应症Prostatic Neoplasms
分期4期
申办方Janssen Research & Development, LLC
状态已完成
受试者人数75 人
干预(药物)Apalutamide, Androgen-deprivation Therapy (ADT)
开始日期2019年12月17日
完成日期2023年6月1日
结果公布日2025年3月28日

摘要

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).

Time to Prostate Specific Antigen (PSA) Progression (TTPP) Based on Prostate Cancer Working Group 2 (PCWG2) Criteria

From randomization until first documented PSA progression (up to 3 years 3 months) · Months

Placebo Plus Androgen-deprivation Therapy (ADT)NA Months
Apalutamide 240 mg Plus ADTNA Months
p-value=0.0052
Hazard Ratio (HR)0.233 (95% CI 0.077–0.705)

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。