title: 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.
abstract: OBJECTIVE
  Orteronel (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.
  
  
  METHODS
  In 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.
  
  
  RESULTS
  The 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%).
  
  
  CONCLUSIONS
  Our study did not meet the primary end point of OS. Longer rPFS and a higher PSA50 rate with orteronel-prednisone indicate antitumor activity.
authors.affiliation: Karim 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.
authors.forename: Karim
authors.initials: K
authors.lastname: Fizazi
authors.affiliation: Karim 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.
authors.forename: Robert
authors.initials: R
authors.lastname: Jones
authors.affiliation: Karim 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.
authors.forename: Stephane
authors.initials: S
authors.lastname: Oudard
authors.affiliation: Karim 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.
authors.forename: Eleni
authors.initials: E
authors.lastname: Efstathiou
authors.affiliation: Karim 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.
authors.forename: Fred
authors.initials: F
authors.lastname: Saad
authors.affiliation: Karim 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.
authors.forename: Ronald
authors.initials: R
authors.lastname: de Wit
authors.affiliation: Karim 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.
authors.forename: Johann
authors.initials: J
authors.lastname: De Bono
authors.affiliation: Karim 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.
authors.forename: Felipe Melo
authors.initials: FM
authors.lastname: Cruz
authors.affiliation: Karim 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.
authors.forename: George
authors.initials: G
authors.lastname: Fountzilas
authors.affiliation: Karim 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.
authors.forename: Albertas
authors.initials: A
authors.lastname: Ulys
authors.affiliation: Karim 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.
authors.forename: Flavio
authors.initials: F
authors.lastname: Carcano
authors.affiliation: Karim 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.
authors.forename: Neeraj
authors.initials: N
authors.lastname: Agarwal
authors.affiliation: Karim 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.
authors.forename: David
authors.initials: D
authors.lastname: Agus
authors.affiliation: Karim 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.
authors.forename: Joaquim
authors.initials: J
authors.lastname: Bellmunt
authors.affiliation: Karim 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.
authors.forename: Daniel P
authors.initials: DP
authors.lastname: Petrylak
authors.affiliation: Karim 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.
authors.forename: Shih-Yuan
authors.initials: SY
authors.lastname: Lee
authors.affiliation: Karim 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.
authors.forename: Iain J
authors.initials: IJ
authors.lastname: Webb
authors.affiliation: Karim 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.
authors.forename: Bindu
authors.initials: B
authors.lastname: Tejura
authors.affiliation: Karim 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.
authors.forename: Niels
authors.initials: N
authors.lastname: Borgstein
authors.affiliation: Karim 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.
authors.forename: Robert
authors.initials: R
authors.lastname: Dreicer
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood*; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005060:Europe; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000008:administration & dosage / Q000009:adverse effects; D060787:Neoplasm Grading; D009656:North America; D016017:Odds Ratio; D010147:Pain Measurement; D011241:Prednisone / Q000008:administration & dosage; D017430:Prostate-Specific Antigen / Q000097:blood*; D064129:Prostatic Neoplasms, Castration-Resistant / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D014408:Biomarkers, Tumor; D007093:Imidazoles; D009281:Naphthalenes; D043823:Taxoids; D000077143:Docetaxel; D017430:Prostate-Specific Antigen; C571806:orteronel; D011241:Prednisone