Evidence map›Paper›PMID 31329516›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer.

Andrew J Armstrong, Russell Z Szmulewitz, Daniel P Petrylak, Jeffrey Holzbeierlein, Arnauld Villers, Arun Azad, Antonio Alcaraz, Boris Alekseev, Taro Iguchi, Neal D Shore and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02677896 (A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy), which is not on this map. Cited by 622 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
622citing papers in PubMed, 11 pooled it
91.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02677896 phase3completednot on this map

A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

TypeinterventionalSponsorAstellas Pharma Global Development, Inc.Ran2016 to 2024Enrolled1,150ConditionsMetastatic Hormone Sensitive Prostate CancerArmsEnzalutamide, Placebo
3 · Its place in the literature

Who cites it

622 citing papers in PubMed, 11 syntheses or guidelines pooled it, 1,136 citations in OpenAlex.

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  9. Cabazitaxel versus abiraterone or enzalutamide for metastatic castration-resistant prostate cancer following docetaxel failure: a systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Pooled it
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  17. Evolution of AR and Non-AR Alterations in ctDNA of Patients with Metastatic Prostate Cancer Treated in the Phase III Alliance A031201 Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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  19. Radiographic Progression With and Without Prostate-Specific Antigen Rise in Patients With Advanced Prostate Cancer Treated With Enzalutamide.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
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562 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 14 institutions in 8 countries.

Andrew J ArmstrongDuke Cancer Institute Center for Prostate and Urologic Cancers, Durham, NC.
Russell Z SzmulewitzThe University of Chicago, Chicago, IL.
Daniel P PetrylakYale Cancer Center, New Haven, CT.
Jeffrey HolzbeierleinThe University of Kansas Medical Center, Kansas City, KS.
Arnauld VillersLille University, Lille, France.
Arun AzadMonash Health, Melbourne, Victoria, Australia.
Antonio AlcarazHospital Clinic of Barcelona, Barcelona, Spain.
Boris AlekseevHertzen Moscow Cancer Research Institute, Moscow, Russia.
Taro IguchiOsaka City University Graduate School of Medicine, Osaka, Japan.
Neal D ShoreCarolina Urologic Research Center, Myrtle Beach, SC.
Brad RosbrookPfizer, San Diego, CA.
Jennifer SuggAstellas Pharma, Northbrook, IL.
Benoit BaronAstellas Pharma, Leiden, the Netherlands.
Lucy ChenAstellas Pharma, Northbrook, IL.
Arnulf StenzlEberhard Karls University of Tübingen, Tübingen, Germany.
Astellas Pharma (United States) · USAstellas Pharma (Netherlands) · NLCarolina Urologic Research Center · USDuke Cancer InstituteHospital Clínic de Barcelona · ESMonash Health · AUOsaka City University · JPP.A. Hertzen Moscow Oncology Research Institute · RUPfizer (United States) · USUniversité de Lille · FRUniversity of Chicago · USUniversity of Kansas Medical Center · USUniversity of Tübingen · DEYale Cancer Center · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Targeting convergent oncogenic signaling during AR inhibition to overcome metastasis and immune evasion in prostate cancerR01CA233585 · NCI · DUKE UNIVERSITY · PI ARMSTRONG, ANDREW J · 2019 to 2023
$2.2M
NCATS NIH HHS UL1 TR001863NCI NIH HHS R01 CA233585
6 · The paper itself

Abstract

purposeEnzalutamide, a potent androgen-receptor inhibitor, has demonstrated significant benefits in metastatic and nonmetastatic castration-resistant prostate cancer. We evaluated the efficacy and safety of enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC).

methodsARCHES (ClinicalTrials.gov identifier: NCT02677896) is a multinational, double-blind, phase III trial, wherein 1,150 men with mHSPC were randomly assigned 1:1 to enzalutamide (160 mg/day) or placebo, plus androgen deprivation therapy (ADT), stratified by disease volume and prior docetaxel chemotherapy. The primary end point was radiographic progression-free survival.

resultsAs of October 14, 2018, the risk of radiographic progression or death was significantly reduced with enzalutamide plus ADT versus placebo plus ADT (hazard ratio, 0.39; 95% CI, 0.30 to 0.50;

conclusionEnzalutamide with ADT significantly reduced the risk of metastatic progression or death over time versus placebo plus ADT in men with mHSPC, including those with low-volume disease and/or prior docetaxel, with a safety analysis that seems consistent with the safety profile of enzalutamide in previous clinical trials in castration-resistant prostate cancer.

Indexed as

AgedAndrogen AntagonistsAntineoplastic Combined Chemotherapy ProtocolsBenzamidesHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasm MetastasisNitrilesPhenylthiohydantoinProgression-Free SurvivalProstatic NeoplasmsAndrogen AntagonistsBenzamidesenzalutamideNitrilesPhenylthiohydantoin

Identifiers

PMID31329516
PMCPMC6839905
OpenAlexW2963794755

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.