Evidence map›Paper›PMID 36996380›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

Randomized Phase III Study of Enzalutamide Compared With Enzalutamide Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer (Alliance A031201 Trial).

Michael J Morris, Glenn Heller, David W Hillman, Olivia Bobek, Charles Ryan, Emmanuel S Antonarakis, Alan H Bryce, Olwen Hahn, Himisha Beltran, Andrew J Armstrong and 13 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07717268 (Radioterapia estereotáctica Fraccionada más antiandrógeno de Segunda generación Para Pacientes oligometastásicos Con cáncer de próstata Resistente a la castración. Estudio español Fase II, Prospectivo, multicéntrico.), which is not on this map. Cited by 38 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 3 pooled it
9.6field-weighted citation impact, top 2% 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.

NCT07717268 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Radioterapia estereotáctica Fraccionada más antiandrógeno de Segunda generación Para Pacientes oligometastásicos Con cáncer de próstata Resistente a la castración. Estudio español Fase II, Prospectivo, multicéntrico.

TypeinterventionalSponsorInstituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología RadioterápicRan2024 to 2030Enrolled51ConditionsProstatic Neoplasms, Castration-ResistantArmsXtandi, Zytiga® (Abiraterone Acetate), SBRT
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 3 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. 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
    Trial
  5. Automated Imaging as an Adjunct to Serum and Clinical Biomarkers: A New Validated Prediction Tool for Metastatic Castration-Resistant Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
  6. Accelerating Drug Development in Hormone-Naïve Prostate Cancer through Multimodal Therapy Strategies: The MetaCURE Phase 2 Randomized Clinical Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Circulating and Intratumoral Adrenal Androgens Correlate with Response to Abiraterone in Men with Castration-Resistant Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Trial
  13. Trial
  14. A Phase Ib/IIa Study of the Pan-BET Inhibitor ZEN-3694 in Combination with Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020
    Trial
  15. Phase Ib Trial of Bavdegalutamide (ARV-110) in Combination with Abiraterone for Metastatic Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Fine structural design of 3βHSD1 inhibitors for prostate cancer therapy.Proceedings of the National Academy of Sciences of the United States of America · 2025
    Article
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

23 authors at 16 institutions in 1 country.

Michael J MorrisGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-9454-0096
Glenn HellerAlliance Statistics and Data Management Center, Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.
David W HillmanAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN.ORCID 0000-0002-0519-1147
Olivia BobekAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN.ORCID 0000-0003-4922-1659
Charles RyanDivision of Hematology, Oncology, and Transplantation, Department of Medicine, University of Minnesota, Minneapolis, MN.
Emmanuel S AntonarakisDivision of Hematology, Oncology, and Transplantation, Department of Medicine, University of Minnesota, Minneapolis, MN.ORCID 0000-0003-0031-9655
Alan H BryceDivision of Hematology and Medical Oncology, Mayo Clinic, Phoenix, AZ.ORCID 0000-0002-0206-3895
Olwen HahnUniversity of Chicago Medical Center, Chicago, IL.
Himisha BeltranDepartment of Medical Oncology, Dana-Farber/Partners Cancer Care, Boston, MA.ORCID 0000-0003-3259-2226
Andrew J ArmstrongDuke Cancer Institute Center for Prostate and Urologic Cancers, Division of Medical Oncology, Department of Medicine, Duke University, Durham, NC.ORCID 0000-0001-7012-1754
Lawrence SchwartzDepartment of Radiology, Columbia University Irving Medical Center, New York, NY.
Lionel D LewisNorris Cotton Cancer Center, The Geisel School of Medicine at Dartmouth and The Dartmouth-Hitchcock Medical Center, Lebanon, NH.
Jan H BeumerUniversity of Pittsburgh, Pittsburgh, PA.ORCID 0000-0002-8978-9401
Brooke LangevinCenter for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, MD.
Eric C McGaryDivision of Medical Oncology, Kaiser Permanente (SCAL) and Kaiser Permanente School of Medicine, Cadillac, CA.
Paul T MehanMissouri Baptist Hospital, St Louis, MO.
Amir GoldkornDivision of Medical Oncology, Department of Medicine, Keck School of Medicine and Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA.ORCID 0000-0003-4664-9166
Bruce J RothWashington University School of Medicine, St Louis, MO.ORCID 0000-0002-9333-571X
Han XiaoGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0001-5292-5687
Colleen WattUniversity of Chicago, Chicago, IL.
Mary-Ellen TaplinDepartment of Medical Oncology, Dana-Farber/Partners Cancer Care, Boston, MA.
Susan HalabiAlliance Statistics and Data Management Center, and Department of Biostatistics and Bioinformatics, Duke University, Durham, NC.ORCID 0000-0003-4135-2777
Eric J SmallUCSF Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA.ORCID 0000-0003-3191-6268
Memorial Sloan Kettering Cancer Center · USMayo Clinic · USUniversity of Minnesota · USColumbia University Irving Medical Center · USDartmouth–Hitchcock Medical Center · USDuke Medical Center · USDuke University · USKaiser Permanente · USMayo Clinic Hospital · USSaint Thomas Midtown Hospital · USUniversity of California, San Francisco · USUniversity of Chicago · USUniversity of Maryland, Baltimore · USUniversity of Pittsburgh · USUniversity of Southern California · USWashington University in St. Louis · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI JOHN C. BYRD · 1988 to 2026
$158.0M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
NCIC Clinical Trials Group - Canadian Collaborating Clinical Trials NetworkU10CA180863 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI Janet Ellen Dancey · 2014 to 2026
$40.4M
Columbia University NCI Community Oncology Research ProgramUG1CA189960 · NCI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI Jennifer E. Amengual, Lisa A. Kachnic · 2014 to 2026
$12.7M
WASHINGTON UNIVERSITY / SITEMAN CANCER CENTER LEAD ACADEMIC SITEUG1CA233339 · NCI · WASHINGTON UNIVERSITY · PI NANCY L BARTLETT, Clifford Grant Robinson · 2019 to 2026
$11.3M
Network Lead Academic Participating Site: Memorial Sloan Kettering Cancer CenterUG1CA233290 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI CAROL AGHAJANIAN, Darren Feldman · 2019 to 2026
$10.2M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareUG1CA233180 · NCI · DANA-FARBER CANCER INST · PI Harold John Burstein · 2019 to 2026
$8.6M
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
NCI NCTN-Network Lead Academic Participating Site at UPMC Hillman Cancer CenterUG1CA233184 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI ADAM M BRUFSKY, John Munn Kirkwood · 2019 to 2026
$7.7M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA047904NCI NIH HHS R50 CA211241NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180882NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA180830NCI NIH HHS UG1 CA189960NCI NIH HHS UG1 CA232760NCI NIH HHS UG1 CA233180NCI NIH HHS UG1 CA233184NCI NIH HHS UG1 CA233253NCI NIH HHS UG1 CA233290NCI NIH HHS UG1 CA233327NCI NIH HHS UG1 CA233339
6 · The paper itself

Abstract

purposeEnzalutamide and abiraterone both target androgen receptor signaling but via different mechanisms. The mechanism of action of one drug may counteract the resistance pathways of the other. We sought to determine whether the addition of abiraterone acetate and prednisone (AAP) to enzalutamide prolongs overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC) in the first-line setting. PATIENTS AND

methodsMen with untreated mCRPC were randomly assigned (1:1) to receive first-line enzalutamide with or without AAP. The primary end point was OS. Toxicity, prostate-specific antigen declines, pharmacokinetics, and radiographic progression-free survival (rPFS) were also examined. Data were analyzed using an intent-to-treat approach. The Kaplan-Meier estimate and the stratified log-rank statistic were used to compare OS between treatments.

resultsIn total, 1,311 patients were randomly assigned: 657 to enzalutamide and 654 to enzalutamide plus AAP. OS was not statistically different between the two arms (median, 32.7 [95% CI, 30.5 to 35.4] months for enzalutamide

conclusionThe addition of AAP to enzalutamide for first-line treatment of mCRPC was not associated with a statistically significant benefit in OS. Drug-drug interactions between the two agents resulting in increased abiraterone clearance may partly account for this result, although these interactions did not prevent the combination regimen from having more nonhematologic toxicity.

Indexed as

Prostatic Neoplasms, Castration-ResistantAbiraterone AcetateAndrostenesAntineoplastic Combined Chemotherapy ProtocolsBenzamidesHumansMaleNitrilesPhenylthiohydantoinPrednisoneTreatment OutcomeabirateroneAbiraterone AcetateAndrostenesBenzamidesenzalutamideNitrilesPhenylthiohydantoinPrednisone

Identifiers

PMID36996380
PMCPMC10414728
OpenAlexW4361253222

What OpenQuestion holds

Textmetadata
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.