Evidence map›Paper›PMID 30028657›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2018

Abiraterone Alone or in Combination With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer With Rising Prostate-Specific Antigen During Enzalutamide Treatment.

Gerhardt Attard, Michael Borre, Howard Gurney, Yohann Loriot, Corina Andresen-Daniil, Ranjith Kalleda, Trinh Pham, Mary-Ellen Taplin, PLATO collaborators

Registry-linked trialOpen access · hybridAbstract readRandomized 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, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01995513 (A PHASE 4, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CONTINUED ENZALUTAMIDE TREATMENT BEYOND PROGRESSION IN PATIENTS WITH CHEMOTHERAPY-NAÏVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER), which is not on this map. Cited by 82 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
82citing papers in PubMed, 5 pooled it
15.8field-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.

NCT01995513 phase4completednot on this map

A phase 4, randomized, double-blind, placebo-controlled study of continued enzalutamide treatment beyond progression in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer

TypeinterventionalSponsorPfizerRan2013 to 2022Enrolled509ConditionsProstate CancerArmsEnzalutamide, Abiraterone, Placebo for Enzalutamide, Prednisone
3 · Its place in the literature

Who cites it

82 citing papers in PubMed, 5 syntheses or guidelines pooled it, 171 citations in OpenAlex.

  1. Pooled it
  2. SEOM clinical guidelines for the treatment of advanced prostate cancer (2020).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021
    Guideline
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Lancet (London, England) · 2024
    Trial
  7. Trial
  8. Trial
  9. Trial
  10. 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
  11. 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
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. 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
  20. Article

22 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

9 authors at 1 institution in 1 country.

Gerhardt AttardGerhardt Attard, The Institute of Cancer Research and the Royal Marsden National Health Service Foundation Trust, London, United Kingdom; Michael Borre, Aarhus University Hospital, Aarhus, Denmark; Howard Gurney, Macquarie University, Sydney, New South Wales, Australia; Yohann Loriot, Gustave Roussy, Institut National de la Santé et de la Recherche Médicale U981, University of Paris Saclay, Villejuif, France; Corina Andresen-Daniil, Ranjith Kalleda, and Trinh Pham, Pfizer, New York, NY; and Mary-Ellen Taplin, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.
Michael BorreGerhardt Attard, The Institute of Cancer Research and the Royal Marsden National Health Service Foundation Trust, London, United Kingdom; Michael Borre, Aarhus University Hospital, Aarhus, Denmark; Howard Gurney, Macquarie University, Sydney, New South Wales, Australia; Yohann Loriot, Gustave Roussy, Institut National de la Santé et de la Recherche Médicale U981, University of Paris Saclay, Villejuif, France; Corina Andresen-Daniil, Ranjith Kalleda, and Trinh Pham, Pfizer, New York, NY; and Mary-Ellen Taplin, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.
Howard GurneyGerhardt Attard, The Institute of Cancer Research and the Royal Marsden National Health Service Foundation Trust, London, United Kingdom; Michael Borre, Aarhus University Hospital, Aarhus, Denmark; Howard Gurney, Macquarie University, Sydney, New South Wales, Australia; Yohann Loriot, Gustave Roussy, Institut National de la Santé et de la Recherche Médicale U981, University of Paris Saclay, Villejuif, France; Corina Andresen-Daniil, Ranjith Kalleda, and Trinh Pham, Pfizer, New York, NY; and Mary-Ellen Taplin, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.
Yohann LoriotGerhardt Attard, The Institute of Cancer Research and the Royal Marsden National Health Service Foundation Trust, London, United Kingdom; Michael Borre, Aarhus University Hospital, Aarhus, Denmark; Howard Gurney, Macquarie University, Sydney, New South Wales, Australia; Yohann Loriot, Gustave Roussy, Institut National de la Santé et de la Recherche Médicale U981, University of Paris Saclay, Villejuif, France; Corina Andresen-Daniil, Ranjith Kalleda, and Trinh Pham, Pfizer, New York, NY; and Mary-Ellen Taplin, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.
Corina Andresen-DaniilGerhardt Attard, The Institute of Cancer Research and the Royal Marsden National Health Service Foundation Trust, London, United Kingdom; Michael Borre, Aarhus University Hospital, Aarhus, Denmark; Howard Gurney, Macquarie University, Sydney, New South Wales, Australia; Yohann Loriot, Gustave Roussy, Institut National de la Santé et de la Recherche Médicale U981, University of Paris Saclay, Villejuif, France; Corina Andresen-Daniil, Ranjith Kalleda, and Trinh Pham, Pfizer, New York, NY; and Mary-Ellen Taplin, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.
Ranjith KalledaGerhardt Attard, The Institute of Cancer Research and the Royal Marsden National Health Service Foundation Trust, London, United Kingdom; Michael Borre, Aarhus University Hospital, Aarhus, Denmark; Howard Gurney, Macquarie University, Sydney, New South Wales, Australia; Yohann Loriot, Gustave Roussy, Institut National de la Santé et de la Recherche Médicale U981, University of Paris Saclay, Villejuif, France; Corina Andresen-Daniil, Ranjith Kalleda, and Trinh Pham, Pfizer, New York, NY; and Mary-Ellen Taplin, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.
Trinh PhamGerhardt Attard, The Institute of Cancer Research and the Royal Marsden National Health Service Foundation Trust, London, United Kingdom; Michael Borre, Aarhus University Hospital, Aarhus, Denmark; Howard Gurney, Macquarie University, Sydney, New South Wales, Australia; Yohann Loriot, Gustave Roussy, Institut National de la Santé et de la Recherche Médicale U981, University of Paris Saclay, Villejuif, France; Corina Andresen-Daniil, Ranjith Kalleda, and Trinh Pham, Pfizer, New York, NY; and Mary-Ellen Taplin, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.
Mary-Ellen TaplinGerhardt Attard, The Institute of Cancer Research and the Royal Marsden National Health Service Foundation Trust, London, United Kingdom; Michael Borre, Aarhus University Hospital, Aarhus, Denmark; Howard Gurney, Macquarie University, Sydney, New South Wales, Australia; Yohann Loriot, Gustave Roussy, Institut National de la Santé et de la Recherche Médicale U981, University of Paris Saclay, Villejuif, France; Corina Andresen-Daniil, Ranjith Kalleda, and Trinh Pham, Pfizer, New York, NY; and Mary-Ellen Taplin, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.
PLATO collaborators
University College London · GB

Funding

Cancer Research UK 22744
6 · The paper itself

Abstract

Purpose Enzalutamide resistance could result from raised androgens and be overcome by combination with abiraterone acetate. PLATO ( ClinicalTrials.gov identifier: NCT01995513) interrogated this hypothesis using a randomized, double-blind, placebo-controlled design. Patients and Methods In period one, men with chemotherapy-naïve metastatic castration-resistant prostate cancer received open-label enzalutamide 160 mg daily. Men with no prostate-specific antigen (PSA) increase at weeks 13 and 21 were treated until PSA progression (≥ 25% increase and ≥ 2 ng/mL above nadir), then randomly assigned at a one-to-one ratio in period two to abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily with either enzalutamide or placebo (combination or control group, respectively) until disease progression as defined by the primary end point: progression-free survival (radiographic or unequivocal clinical progression or death during study). Secondary end points included time to PSA progression and PSA response in period two. Results Of 509 patients enrolled in period one, 251 were randomly assigned in period two. Median progression-free survival was 5.7 months in the combination group and 5.6 months in the control group (hazard ratio, 0.83; 95% CI, 0.61 to 1.12; P = .22). There was no difference in the secondary end points. Grade 3 hypertension (10% v 2%) and increased ALT (6% v 2%) or AST (2% v 0%) were more frequent in the combination than the control group. Conclusion Combining enzalutamide with abiraterone acetate and prednisone is not indicated after PSA progression during treatment with enzalutamide alone; hypertension and elevated liver enzymes are more frequent with combination therapy.

Indexed as

AndrostenesAntineoplastic AgentsBenzamidesDouble-Blind MethodDrug Resistance, NeoplasmHumansHypertensionLiverMaleNitrilesPhenylthiohydantoinProgression-Free SurvivalProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantTreatment OutcomeabirateroneAndrostenesAntineoplastic AgentsBenzamidesenzalutamideNitrilesPhenylthiohydantoinProstate-Specific Antigen

Identifiers

PMID30028657
PMCPMC6118405
OpenAlexW2884762657

What OpenQuestion holds

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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.