Evidence map›Paper›PMID 39279580›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial.

Fred Saad, Egils Vjaters, Neal Shore, David Olmos, Nianzeng Xing, Andrea Juliana Pereira de Santana Gomes, Augusto Cesar de Andrade Mota, Pamela Salman, Mindaugas Jievaltas, Albertas Ulys and 9 more

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
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, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 87 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
87citing papers in PubMed, 11 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

87 citing papers in PubMed, 11 syntheses or guidelines pooled it.

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  15. 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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27 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Fred SaadDepartment of Surgery/Urology, Centre Hospitalier de l'Université de Montréal, University of Montreal, Montreal, QC, Canada.ORCID 0000-0003-2986-5617
Egils VjatersP. Stradinš Clinical University Hospital, Riga, Latvia.ORCID 0000-0003-0054-3745
Neal ShoreCarolina Urologic Research Center and AUC Urology Specialists, Myrtle Beach, SC.ORCID 0000-0001-5767-0548
David OlmosDepartment of Medical Oncology, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital 12 de Octubre (Imas 12), Madrid, Spain.ORCID 0000-0002-7003-4826
Nianzeng XingDepartment of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.ORCID 0009-0008-2463-8021
Andrea Juliana Pereira de Santana GomesLiga Norte Riograndense Contra O Cancer, Natal, Brazil.ORCID 0000-0001-7388-663X
Augusto Cesar de Andrade MotaMedical Oncology, Instituto ETICA-Clinica AMO/DASA, Salvador, Brazil.ORCID 0000-0002-4398-2708
Pamela SalmanOncovida Research, Santiago, Chile.ORCID 0000-0003-4389-8124
Mindaugas JievaltasLithuanian University of Health Sciences, Medical Academy, Kaunas, Lithuania.
Albertas Ulys0National Cancer Institute, Vilnius University, Vilnius, Lithuania.
Maris JakubovskisClinic of Urology and Oncological Urology, Riga East University Hospital, Riga, Latvia.
Evgeny KopyltsovClinical Oncological Dispensary of Omsk Region, Omsk, Russian Federation.
Weiqing HanDepartment of Urology, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Hunan Cancer Center, Changsha, China.
Liina NevalaitaOrion Corporation, Orion Pharma, Espoo, Finland.
Isabella TestaBayer S.p.A, Milan, Italy.
Marie-Aude Le BerreBayer Healthcare SAS, Lille, France.
Iris KussBayer AG, Berlin, Germany.
Kunhi Parambath HareshAll India Institute of Medical Sciences, New Delhi, India.
ARANOTE Study Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeFor patients with metastatic hormone-sensitive prostate cancer (mHSPC), delaying progression to castration-resistant disease is important not only for overall survival (OS) but also for patients' quality of life. Darolutamide plus androgen-deprivation therapy (ADT) with docetaxel improved OS versus ADT and docetaxel in patients with mHSPC. The ARANOTE trial evaluated darolutamide and ADT without chemotherapy in patients with mHSPC.

methodsIn this global phase III trial, patients were randomly assigned 2:1 to receive darolutamide 600 mg twice daily or placebo, with concomitant ADT. The primary end point was radiological progression-free survival (rPFS).

resultsFrom March 2021 to August 2022, 669 patients were randomly assigned (darolutamide n = 446; placebo n = 223). At the primary cutoff date (June 7, 2024), darolutamide plus ADT significantly improved rPFS, reducing the risk of radiological progression or death by 46% versus placebo plus ADT (hazard ratio [HR], 0.54 [95% CI, 0.41 to 0.71];

conclusionThese results confirm the efficacy and tolerability of darolutamide plus ADT in patients with mHSPC, demonstrating clinically and statistically significant improvement in rPFS and a favorable safety profile consistent with prior phase III darolutamide trials.

Indexed as

Androgen AntagonistsAntineoplastic Combined Chemotherapy ProtocolsPyrazolesAgedAged, 80 and overDouble-Blind MethodHumansMaleMiddle AgedProgression-Free SurvivalProstatic NeoplasmsProstatic Neoplasms, Castration-ResistantSulfonamidesAndrogen AntagonistsdarolutamidePyrazolesSulfonamides

Identifiers

PMID39279580
PMCPMC11654448

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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 Socratic graph.