Evidence map›Paper›PMID 37812679›Full record

ArticleThe oncologist2024

Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy and Docetaxel in Black Patients From the Randomized ARASENS Trial.

Neal D Shore, Maha Hussain, Fred Saad, Karim Fizazi, Cora N Sternberg, David Crawford, Bertrand Tombal, Luke Nordquist, Michael Cookson, Frank Verholen and 3 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The oncologist, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02799602 (A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 24% 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.

NCT02799602 phase3completednot on this map

A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer

TypeinterventionalSponsorBayerRan2016 to 2023Enrolled1,306ConditionsMetastatic Hormone-sensitive Prostate CancerArmsBAY1841788 / darolutamide (ODM-201), Standard ADT (androgen deprivation therapy), Docetaxel, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
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

13 authors at 12 institutions in 5 countries.

Neal D ShoreCarolina Urologic Research Center/Genesis Care, Myrtle Beach, SC, USA.
Maha HussainRobert H. Lurie Comprehensive Cancer Center, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.
Fred SaadCentre Hospitalier de l'Université de Montréal, University of Montreal, Montreal, Quebec, Canada.
Karim FizaziInstitut Gustave Roussy, University of Paris-Saclay, Villejuif, France.
Cora N SternbergEnglander Institute for Precision Medicine, Weill Cornell Department of Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York, NY, USA.
David CrawfordUniversity of California San Diego School of Medicine, San Diego, CA, USA.
Bertrand TombalDivision of Urology, IREC, Cliniques Universitaires Saint Luc, UCLouvain, Brussels, Belgium.
Luke NordquistXCancer/GU Research Network, Omaha, NE, USA.
Michael CooksonUniversity of Oklahoma Stephenson Cancer Center, Oklahoma City, OK, USA.
Frank VerholenBayer Consumer Care, Basel, Switzerland.
Jay JhaveriBayer Healthcare Pharmaceuticals, Inc., Whippany, NJ, USA.
Shankar SrinivasanBayer Healthcare Pharmaceuticals, Inc., Whippany, NJ, USA.
Matthew R SmithMassachusetts General Hospital Cancer Center, Boston, MA, USA.
Bayer (United States) · USBayer (Switzerland) · CHCarolina Urologic Research Center · USCentre Hospitalier de l’Université de Montréal · CACliniques Universitaires Saint-Luc · BEMassachusetts General Hospital · USNew York Hospital Queens · USNorthwestern University · USOklahoma State University Oklahoma City · USResearch Network (United States) · USUniversité Paris-Saclay · FRUniversity of California San Diego · US

Funding

Bayer and Orion Pharma
6 · The paper itself

Abstract

backgroundIn the ARASENS trial (NCT02799602), darolutamide in combination with androgen-deprivation therapy (ADT) and docetaxel significantly reduced the risk of death by 32.5% (HR, 0.68; 95% CI, 0.57-0.80; P < .0001) compared with placebo plus ADT with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC). We present efficacy and safety of darolutamide versus placebo in Black patients from ARASENS. PATIENTS AND

methodsPatients with mHSPC were randomized 1:1 to darolutamide 600 mg or placebo twice daily in combination with ADT and docetaxel. The primary endpoint was overall survival. Key secondary endpoints included time to castration-resistant prostate cancer (CRPC) and safety.

resultsIn ARASENS, 54 Black patients received darolutamide (n = 26) or placebo (n = 28) plus ADT and docetaxel. In Black patients, overall survival favored darolutamide versus placebo (median, not reached vs. 38.7 months; stratified HR, 0.41; 95% CI, 0.17-1.02), with 4-year survival rates of 62% versus 41%. The darolutamide group also had longer time to CRPC compared with the placebo group (median, not reached vs .12.6 months; HR, 0.09; 95% CI, 0.02-0.30). The safety profile of darolutamide in Black patients was consistent with that observed for the overall ARASENS population (grade 3/4 treatment-emergent adverse events, TEAEs: 61.5% vs. 66.1%; serious TEAEs: 42.3% vs. 44.8%).

conclusionIn this small population of Black patients with mHSPC from the ARASENS trial, darolutamide was associated with an improvement in survival and time to CRPC and was well tolerated. Efficacy and safety findings in Black patients were consistent with the overall ARASENS population.

Indexed as

Prostatic NeoplasmsProstatic Neoplasms, Castration-ResistantPyrazolesAndrogen AntagonistsAntineoplastic Combined Chemotherapy ProtocolsDocetaxelHumansMaleRandomized Controlled Trials as TopicAndrogen AntagonistsdarolutamideDocetaxelPyrazolesandrogen receptor inhibitorBlackdarolutamidemetastatic hormone-sensitive prostate cancersafetysurvival analyses

Identifiers

PMID37812679
PMCPMC10911916
OpenAlexW4387449548

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.