Evidence map›Paper›PMID 25624429›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2015

Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer that has progressed during or after docetaxel-based therapy: ELM-PC 5.

Karim Fizazi, Robert Jones, Stephane Oudard, Eleni Efstathiou, Fred Saad, Ronald de Wit, Johann De Bono, Felipe Melo Cruz, George Fountzilas, Albertas Ulys and 10 more

Abstract readClinical Trial, Phase IIIComparative StudyMulticenter 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, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 8 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

74 citing papers in PubMed, 8 syntheses or guidelines pooled it.

  1. Pooled it
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  6. Meta-Analysis Evaluating the Impact of Site of Metastasis on Overall Survival in Men With Castration-Resistant Prostate Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016
    Pooled it
  7. Guideline
  8. Pooled it
  9. Trial
  10. Trial
  11. Open-label phase II clinical trial of orteronel (TAK-700) in metastatic or advanced non-resectable granulosa cell ovarian tumors: the Greko II study (GETHI2013-01).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Trial
  12. Orteronel for Metastatic Hormone-Sensitive Prostate Cancer: A Multicenter, Randomized, Open-Label Phase III Trial (SWOG-1216).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Trial
  13. Article
  14. Review
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14 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Karim FizaziKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain. karim.fizazi@gustaveroussy.fr.
Robert JonesKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
Stephane OudardKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
Eleni EfstathiouKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
Fred SaadKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
Ronald de WitKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
Johann De BonoKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
Felipe Melo CruzKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
George FountzilasKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
Albertas UlysKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
Flavio CarcanoKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
Neeraj AgarwalKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
David AgusKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
Joaquim BellmuntKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
Daniel P PetrylakKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
Shih-Yuan LeeKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
Iain J WebbKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
Bindu TejuraKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
Niels BorgsteinKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.
Robert DreicerKarim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif; Stephane Oudard, Université Paris Descartes, Paris, France; Robert Jones, Institute of Cancer Sciences, University of Glasgow, Glasgow; Johann De Bono, The Institute of Cancer Research, London, United Kingdom; Eleni Efstathiou, University of Athens Medical School, Athens; George Fountzilas, Aristotle University of Thessaloniki School of Medicine, Thessaloniki, Greece; Fred Saad, University of Montreal Hospital Center, Montreal, Canada; Ronald de Wit, Erasmus University Medical Center, Rotterdam, the Netherlands; Felipe Melo Cruz, ABC Foundation School of Medicine, Santo André; Flavio Carcano, Hospital de Cancer de Barretos, Barretos, Brazil; Albertas Ulys, Institut of Oncology, Vilnius University, Vilnius, Lithuania; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; David Agus, University of Southern California, Los Angeles, CA; Daniel P. Petrylak, Yale University Cancer Center, New Haven, CT; Shih-Yuan Lee, Bindu Tejura, Niels Borgstein, Takeda Pharmaceuticals International; Iain J. Webb, Millennium: The Takeda Oncology Company, Cambridge, MA; Robert Dreicer, Cleveland Clinic, Cleveland, OH; Joaquim Bellmunt, University Hospital del Mar-IMIM, Barcelona, Spain.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
6 · The paper itself

Abstract

purposeOrteronel (TAK-700) is an investigational, nonsteroidal, reversible, selective 17,20-lyase inhibitor. This study examined orteronel in patients with metastatic castration-resistant prostate cancer that progressed after docetaxel therapy. PATIENTS AND

methodsIn our study, 1,099 men were randomly assigned in a 2:1 schedule to receive orteronel 400 mg plus prednisone 5 mg twice daily or placebo plus prednisone 5 mg twice daily, stratified by region (Europe, North America [NA], and non-Europe/NA) and Brief Pain Inventory-Short Form worst pain score. Primary end point was overall survival (OS). Key secondary end points (radiographic progression-free survival [rPFS], ≥ 50% decrease of prostate-specific antigen [PSA50], and pain response at 12 weeks) were to undergo statistical testing only if the primary end point analysis was significant.

resultsThe study was unblinded after crossing a prespecified OS futility boundary. The median OS was 17.0 months versus 15.2 months with orteronel-prednisone versus placebo-prednisone (hazard ratio [HR], 0.886; 95% CI, 0.739 to 1.062; P = .190). Improved rPFS was observed with orteronel-prednisone (median, 8.3 v 5.7 months; HR, 0.760; 95% CI, 0.653 to 0.885; P < .001). Orteronel-prednisone showed advantages over placebo-prednisone in PSA50 rate (25% v 10%, P < .001) and time to PSA progression (median, 5.5 v 2.9 months, P < .001) but not pain response rate (12% v 9%; P = .128). Adverse events (all grades) were generally more frequent with orteronel-prednisone, including nausea (42% v 26%), vomiting (36% v 17%), fatigue (29% v 23%), and increased amylase (14% v 2%).

conclusionOur study did not meet the primary end point of OS. Longer rPFS and a higher PSA50 rate with orteronel-prednisone indicate antitumor activity.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorDisease-Free SurvivalDisease ProgressionDocetaxelDouble-Blind MethodDrug Administration ScheduleEuropeHumansImidazolesKaplan-Meier EstimateMaleMiddle AgedBiomarkers, TumorDocetaxelImidazolesNaphthalenesorteronelPrednisoneProstate-Specific AntigenTaxoids

Identifiers

PMID25624429
PMCPMC4879718

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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.