Evidence map›Paper›PMID 29420164›Full record

Trial reportThe New England journal of medicine2018

Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer.

Matthew R Smith, Fred Saad, Simon Chowdhury, Stéphane Oudard, Boris A Hadaschik, Julie N Graff, David Olmos, Paul N Mainwaring, Ji Youl Lee, Hiroji Uemura and 9 more

5 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 617 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
617citing papers in PubMed, 4 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.

NCT01946204 phase3active not recruitingnot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer

TypeinterventionalSponsorAragon Pharmaceuticals, Inc.Ran2013 to 2027Enrolled1,207ConditionsProstatic NeoplasmsArmsApalutamide, Placebo
NCT04234399 terminatednot on this mapstarted 2020, after this paper: background citation

Determination of the Diagnostic Detection Rate of Axumin (Fluciclovine) PET/CT Utilizing the High Resolution Digital Philips Vereos Scanner, in Patients With Biochemical Recurrence After Radical Prostatectomy

TypeobservationalSponsorUniversity of VermontRan2020 to 2024Enrolled22ConditionsProstatic NeoplasmArmsFluciclovine PET/CT using a digital PET/CT
NCT04409288 phase3terminatednot on this mapstarted 2020, after this paper: background citation

Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer: An Open-label, Randomized, Cross-Over Trial.

TypeinterventionalSponsorChinese University of Hong KongRan2020 to 2023Enrolled74ConditionsProstate CancerArmsApalutamide, Enzalutamide
NCT05717660 phase2unknown statusnot on this mapstarted 2023, after this paper: background citation

APalutamide and stEReotactic Body Radiation Therapy for Low Burden Metastatic Hormone senSItive Prostate Cancer, a rANdomized Trial - PERSIAN

TypeinterventionalSponsorAzienda Ospedaliero-Universitaria CareggiRan2023 to 2025Enrolled180ConditionsOligometastatic Hormone Sensitive Prostate CancerArmsSBRT on all sites of metastatic disease+Apalutamide
NCT07260435 phase3recruitingnot on this mapstarted 2024, after this paper: background citation

Apa/Enza Short Study: Shortened 12 Months Duration of Androgen Receptor Signaling Agent in Combination With Androgen Deprivation Therapy in Patients With Low Volume Castration-sensitive Prostate Cancer: a Randomized Nationwide Study

TypeinterventionalSponsorNick BeijeRan2024 to 2027Enrolled400ConditionsProstate CancerArmsADT plus only 12 months of ARPI, ADT plus continued ARPI
3 · Its place in the literature

Who cites it

617 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  6. Radiographic Progression With and Without Prostate-Specific Antigen Rise in Patients With Advanced Prostate Cancer Treated With Enzalutamide.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
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557 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

Matthew R SmithFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
Fred SaadFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
Simon ChowdhuryFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
Stéphane OudardFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
Boris A HadaschikFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
Julie N GraffFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
David OlmosFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
Paul N MainwaringFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
Ji Youl LeeFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
Hiroji UemuraFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
Angela Lopez-GitlitzFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
Géralyn C TrudelFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
Byron M EspinaFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
Youyi ShuFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
Youn C ParkFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
Wayne R RackoffFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
Margaret K YuFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
Eric J SmallFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (M.R.S.); Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal (F.S.); Guy's, King's and St. Thomas' Hospitals, Great Maze Pond, London (S.C.); Georges Pompidou Hospital, Paris (S.O.); University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany (B.A.H.); Veterans Affairs Portland Health Care System, Portland, and Knight Cancer Institute, Oregon Health and Science University, Portland (J.N.G.); Spanish National Cancer Research Center, Madrid, and Hospitales Universitarios Virgen de la Victoria y Regional, Institute of Biomedical Research in Malaga, Malaga - both in Spain (D.O.); Centre for Personalised Nanomedicine, University of Queensland, Brisbane, Australia (P.N.M.); St. Mary's Hospital of Catholic University, Seoul, South Korea (J.Y.L.); Yokohama City University Medical Center, Yokohama, Japan (H.U.); Janssen Research and Development, Los Angeles (A.L.-G., G.C.T., B.M.E., Y.S., Y.C.P., W.R.R., M.K.Y.); and Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco (E.J.S.).
SPARTAN Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundApalutamide, a competitive inhibitor of the androgen receptor, is under development for the treatment of prostate cancer. We evaluated the efficacy of apalutamide in men with nonmetastatic castration-resistant prostate cancer who were at high risk for the development of metastasis.

methodsWe conducted a double-blind, placebo-controlled, phase 3 trial involving men with nonmetastatic castration-resistant prostate cancer and a prostate-specific antigen doubling time of 10 months or less. Patients were randomly assigned, in a 2:1 ratio, to receive apalutamide (240 mg per day) or placebo. All the patients continued to receive androgen-deprivation therapy. The primary end point was metastasis-free survival, which was defined as the time from randomization to the first detection of distant metastasis on imaging or death.

resultsA total of 1207 men underwent randomization (806 to the apalutamide group and 401 to the placebo group). In the planned primary analysis, which was performed after 378 events had occurred, median metastasis-free survival was 40.5 months in the apalutamide group as compared with 16.2 months in the placebo group (hazard ratio for metastasis or death, 0.28; 95% confidence interval [CI], 0.23 to 0.35; P<0.001). Time to symptomatic progression was significantly longer with apalutamide than with placebo (hazard ratio, 0.45; 95% CI, 0.32 to 0.63; P<0.001). The rate of adverse events leading to discontinuation of the trial regimen was 10.6% in the apalutamide group and 7.0% in the placebo group. The following adverse events occurred at a higher rate with apalutamide than with placebo: rash (23.8% vs. 5.5%), hypothyroidism (8.1% vs. 2.0%), and fracture (11.7% vs. 6.5%).

conclusionsAmong men with nonmetastatic castration-resistant prostate cancer, metastasis-free survival and time to symptomatic progression were significantly longer with apalutamide than with placebo. (Funded by Janssen Research and Development; SPARTAN ClinicalTrials.gov number, NCT01946204 .).

Indexed as

AdenocarcinomaAgedAged, 80 and overAndrogen AntagonistsDisease-Free SurvivalDisease ProgressionDouble-Blind MethodExanthemaHumansMaleMiddle AgedNeoplasm MetastasisProportional Hazards ModelsProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantThiohydantoinsAndrogen AntagonistsapalutamideProstate-Specific AntigenThiohydantoins

Identifiers

PMID29420164

What OpenQuestion holds

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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.