Evidence map›Paper›PMID 40043230›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025

Pembrolizumab Plus Docetaxel Versus Docetaxel for Previously Treated Metastatic Castration-Resistant Prostate Cancer: The Randomized, Double-Blind, Phase III KEYNOTE-921 Trial.

Daniel P Petrylak, Raffaele Ratta, Nobuaki Matsubara, Ernesto Korbenfeld, Rustem Gafanov, Loic Mourey, Tilman Todenhöfer, Howard Gurney, Gero Kramer, Andries M Bergman and 16 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03834506 (A Phase 3, Randomized, Double-blind Study of Pembrolizumab), which is not on this map. Cited by 48 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 3 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.

NCT03834506 phase3completednot on this map

A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2019 to 2023Enrolled1,030ConditionsProstatic NeoplasmsArmsPembrolizumab, Docetaxel, Prednisone, Placebo, Dexamethasone
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Clinical advances and practice updates in genitourinary cancers: a 2025 review from the multidisciplinary Spanish 'Cambados annual meeting'.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  8. Article
  9. Review
  10. Review
  11. Article
  12. Article
  13. B7-H3 Gene Expression Shapes Prognosis and Therapeutic Opportunities across Patient Groups with Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Article
  20. Targeting prostate adenocarcinoma tumor microenvironment via cancer nanotheranostics: a comprehensive update on improved roadmap for disease diagnosis, therapy and management.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    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

26 authors.

Daniel P PetrylakYale Cancer Center, New Haven, CT.ORCID 0000-0001-6165-5797
Raffaele RattaHopital Foch, Suresnes, France.
Nobuaki MatsubaraNational Cancer Center Hospital East, Chiba, Japan.ORCID 0000-0002-9203-4245
Ernesto KorbenfeldHospital Britanico de Buenos Aires, Buenos Aires, Argentina.
Rustem GafanovRussian Scientific Center of Roentgenoradiology, Moscow, Russia.ORCID 0000-0002-7592-0392
Loic MoureyInstitut Claudius Regaud IUCT Oncopole, Toulouse, France.
Tilman TodenhöferStudienpraxis Urologie, Nürtingen, Germany.
Howard GurneyMacquarie University, Sydney, Australia.ORCID 0000-0003-0217-5261
Gero KramerDepartment of Urology, Medical University of Vienna, Vienna, Austria.
Andries M BergmanNetherlands Cancer Institute, Amsterdam, the Netherlands.ORCID 0000-0001-5223-2549
Pawel ZalewskiLakeridge Health, Oshawa, ON, Canada.
Maria De SantisDepartment of Urology, Medical University of Vienna, Vienna, Austria.
Andrew J ArmstrongDuke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC.ORCID 0000-0001-7012-1754
Winald GerritsenRadboud University Medical Center, Nijmegen, the Netherlands.
Russell PachynskiWashington University School of Medicine, St Louis, MO.ORCID 0000-0002-8966-7631
Seok Soo ByunSeoul National University Bundang Hospital, Seongnam, South Korea.
Margitta RetzRechts der Isar Medical Center, Technical University Munich, Munich, Germany.
Eric LevesqueCHU de Québec-Université Laval-Hôtel-Dieu de Québec, Québec City, QC, Canada.
Ray McDermottSt Vincent's University Hospital, Cancer Trials Ireland, Dublin, Ireland.ORCID 0000-0002-8952-4315
Sergio BracardaAzienda Ospedaliera Santa Maria Terni, Terni, Italy.ORCID 0000-0002-0703-2959
Ray MannehSociedad de Oncología y Hematología del Cesar, Valledupar, Colombia.ORCID 0000-0002-8106-9741
Meital LevartovskyChaim Sheba Medical Center, Ramat Gan, Israel.
Xin Tong LiMerck & Co, Inc, Rahway, NJ.
Charles SchlossMerck & Co, Inc, Rahway, NJ.ORCID 0000-0002-5106-3082
Christian H PoehleinMerck & Co, Inc, Rahway, NJ.ORCID 0000-0002-3348-3059
Karim FizaziInstitut Gustave Roussy, University of Paris Saclay, Villejuif, France.ORCID 0000-0002-6068-9474

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe standard of care for metastatic castration-resistant prostate cancer (mCRPC) after second-generation androgen receptor pathway inhibitor (ARPI) therapy is still docetaxel. The randomized, double-blind, phase III KEYNOTE-921 trial (Clinicaltrials.gov identifier: NCT03834506) evaluated the efficacy and safety of pembrolizumab or placebo plus docetaxel for previously treated mCRPC.

methodsAdults with mCRPC who progressed after androgen-deprivation therapy and one ARPI were randomly assigned 1:1 to pembrolizumab or placebo plus docetaxel with concomitant prednisone. Dual primary end points were radiographic progression-free survival (rPFS) by blinded independent central review per Prostate Cancer Working Group 3-modified RECIST 1.1 and overall survival (OS). Safety was a secondary end point.

resultsBetween May 30, 2019, and June 17, 2021, 515 participants were randomly assigned to pembrolizumab plus docetaxel and 515 to placebo plus docetaxel. Median time from random assignment to data cutoff date (June 20, 2022) at final analysis (FA) was 22.7 months (range, 12.1-36.7). At first interim analysis (data cutoff date: September 27, 2021), median rPFS was 8.6 months (95% CI, 8.3 to 10.2) with pembrolizumab plus docetaxel versus 8.3 months (95% CI, 8.2 to 8.5) with placebo plus docetaxel (hazard ratio [HR], 0.85 [95% CI, 0.71 to 1.01];

conclusionThe addition of pembrolizumab to docetaxel did not significantly improve efficacy outcomes for participants with previously treated mCRPC. The current standard of care remains unchanged.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDocetaxelProstatic Neoplasms, Castration-ResistantAgedDouble-Blind MethodHumansMaleMiddle AgedProgression-Free SurvivalAntibodies, Monoclonal, HumanizedDocetaxelpembrolizumab

Identifiers

PMID40043230
PMCPMC12058370

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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.