{"entity":{"id":"nct04076059","kind":"trial","name":"An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormo","aka":["China ARCHES"],"tldr":"A phase 3 trial of Enzalutamide in prostate cancer, run by Astellas (Beijing) Pharmaceutical R&D Co., Ltd., active and no longer recruiting.","summary":"An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) is a phase 3 interventional study registered as NCT04076059 by Astellas (Beijing) Pharmaceutical R&D Co., Ltd., with 180 participants enrolled, started 2019-09-11 and due to reach its primary completion in 2022-11-18. Interventions recorded: Enzalutamide, Placebo, Androgen deprivation therapy (ADT). Conditions listed: Metastatic Hormone Sensitive Prostate Cancer. Results were posted on ClinicalTrials.gov in 2023; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04076059","url":"https://clinicaltrials.gov/study/NCT04076059"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate","prostate-mhspc"],"sections":[],"technologies":["androgen-deprivation"],"targets":[],"drugs":["enzalutamide"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04076059","phase":"3","setting":"China ARCHES: A Multicenter, Phase 3, Randomized, Double-blind, Placebo Controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)","sponsor":"Astellas (Beijing) Pharmaceutical R&D Co., Ltd.","started":"2019-09-11","startedType":"actual","yearReported":2023,"enrolled":180,"enrolledBasis":"registry","outcomes":[{"endpoint":"Time to Prostrate Specific Antigen (PSA) Progression","primary":true,"unit":"months","arms":[{"name":"Enzalutamide Plus Androgen Deprivation Therapy (ADT) (Double Blind Phase)","n":120,"note":"Not Reached. Data was not estimable due to low number of events; Figures from the ClinicalTrials.gov results section (first posted 2023-11-18), not from a publication"},{"name":"Placebo Plus ADT (Double Blind Phase)","n":60,"value":9.2,"note":"95% CI 6.54 to 17.48"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT04076059?tab=results"},{"endpoint":"Radiographic Progression-Free Survival (rPFS)","unit":"months","arms":[{"name":"Enzalutamide Plus Androgen Deprivation Therapy (ADT) (Double Blind Phase)","n":120,"note":"Not Reached. Median and upper CI was not estimable due to low number of events; Figures from the ClinicalTrials.gov results section (first posted 2023-11-18), not from a publication"},{"name":"Placebo Plus ADT (Double Blind Phase)","n":60,"value":19.4,"note":"95% CI 13.63 to NA"}],"p":"<0.0001","source":"https://clinicaltrials.gov/study/NCT04076059?tab=results"},{"endpoint":"Objective Response Rate (ORR)","unit":"%","arms":[{"name":"Enzalutamide Plus Androgen Deprivation Therapy (ADT) (Double Blind Phase)","n":47,"value":76.6,"note":"95% CI 62.0 to 87.7; Figures from the ClinicalTrials.gov results section (first posted 2023-11-18), not from a publication"},{"name":"Placebo Plus ADT (Double Blind Phase)","n":22,"value":81.8,"note":"95% CI 59.7 to 94.8"}],"p":"0.8312","source":"https://clinicaltrials.gov/study/NCT04076059?tab=results"}]},"route":"/trials/nct04076059/","neighbours":{"cancer":[{"id":"prostate-mhspc","kind":"cancer","name":"Metastatic hormone-sensitive prostate cancer","route":"/cancers/prostate-mhspc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"androgen-deprivation","kind":"technology","name":"Androgen deprivation & AR pathway inhibitors","route":"/technologies/androgen-deprivation/"}],"drug":[{"id":"enzalutamide","kind":"drug","name":"Enzalutamide","route":"/drugs/enzalutamide/"}],"company":[{"id":"astellas","kind":"company","name":"Astellas","route":"/companies/astellas/"}]}}