Evidence map›Paper›PMID 35179323›Full record

Trial reportThe New England journal of medicine2022

Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer.

Matthew R Smith, Maha Hussain, Fred Saad, Karim Fizazi, Cora N Sternberg, E David Crawford, Evgeny Kopyltsov, Chandler H Park, Boris Alekseev, Álvaro Montesa-Pino and 16 more

4 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 496 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
496citing papers in PubMed, 11 pooled it
120.2field-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.

NCT02799602 phase3completednot on this map

A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer

TypeinterventionalSponsorBayerRan2016 to 2023Enrolled1,306ConditionsMetastatic Hormone-sensitive Prostate CancerArmsBAY1841788 / darolutamide (ODM-201), Standard ADT (androgen deprivation therapy), Docetaxel, Placebo
NCT05471427 completednot on this map

Predictive fActors for toleraNce to Taxane Based CHemotherapy In Older adultS Affected by mEtastatic Prostate Cancer, a Prospective Observational Study (ANCHISES)

TypeobservationalSponsorAzienda Ospedaliero-Universitaria CareggiRan2020 to 2022Enrolled118ConditionsElderly Patients, Metastatic Prostate CancerArmsTaxane chemotherapy
NCT06306612 narecruitingnot on this mapstarted 2024, after this paper: background citation

Systemic Therapy Combined With Cytoreductive Prostatectomy for the Treatment of de Novo Poly-metastatic Hormone Sensitive Prostate Cancer: A Prospective, Open-label Randomized Controlled Trial

TypeinterventionalSponsorRenJi HospitalRan2024 to 2028Enrolled192ConditionsProstate CancerArmsSystemic Chemohormonal Therapy, Systemic Hormonal Therapy, Cytoreductive Prostatectomy, Postoperative Adjuvant Radiotherapy
NCT07503379 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC: a Multi-center, Prospective, Single-arm Study

TypeinterventionalSponsorYonghong LiRan2026 to 2028Enrolled109ConditionsmHSPCArmsDarolutamide + ADT Combined with Low-dose Docetaxel
3 · Its place in the literature

Who cites it

496 citing papers in PubMed, 11 syntheses or guidelines pooled it, 851 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. 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
    Trial
  17. Trial
  18. Trial
  19. Accelerating Drug Development in Hormone-Naïve Prostate Cancer through Multimodal Therapy Strategies: The MetaCURE Phase 2 Randomized Clinical Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
  20. Trial

436 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 1 institution in 1 country.

Matthew R SmithFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Maha HussainFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Fred SaadFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Karim FizaziFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Cora N SternbergFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
E David CrawfordFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Evgeny KopyltsovFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Chandler H ParkFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Boris AlekseevFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Álvaro Montesa-PinoFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Dingwei YeFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Francis ParnisFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Felipe CruzFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).ORCID 0000-0002-4558-4850
Teuvo L J TammelaFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Hiroyoshi SuzukiFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Tapio UtriainenFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Cheng FuFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Motohide UemuraFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
María J Méndez-VidalFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Benjamin L MaughanFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Heikki JoensuuFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Silke ThieleFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Rui LiFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Iris KussFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
Bertrand TombalFrom the Massachusetts General Hospital Cancer Center and Harvard Medical School - both in Boston (M.R.S.); the Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago (M.H.); the University of Montreal Hospital Center, Montreal (F.S.); Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France (K.F.); the Englander Institute for Precision Medicine, Weill Cornell Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York (C.N.S.); the University of California San Diego School of Medicine, La Jolla (E.D.C.); the Clinical Oncologic Dispensary of Omsk Region, Omsk (E.K.), and P. Hertsen Moscow Oncology Research Institute, Moscow (B.A.) - both in Russia; Norton Cancer Institute, Louisville, KY (C.H.P.); La Unidad de Gestión Clínica Intercentros de Oncología Médica, Hospitales Universitarios Regional y Virgen Victoria, Instituto de Investigación Biomédica de Málaga, Malaga (A.M.-P.), and Maimonides Institute for Biomedical Research of Córdoba, Reina Sofía University Hospital, Cordoba (M.J.M.-V.) - both in Spain; Fudan University Shanghai Cancer Center, Shanghai (D.Y.), and Liaoning Cancer Hospital and Institute, Shenyang (C.F.) - both in China; Ashford Cancer Centre Research, Kurralta Park, SA, Australia (F.P.); Núcleo de Pesquisa e Ensino da Rede São Camilo, São Paulo (F.C.); Tampere University Hospital and Tampere University, Tampere (T.L.J.T.), Helsinki University Central Hospital, Comprehensive Cancer Center, Helsinki (T.U.), and Orion Pharma, Espoo (H.J.) - all in Finland; Toho University Sakura Medical Center, Chiba (H.S.), and Osaka University Hospital, Osaka (M.U.) - both in Japan; the Huntsman Cancer Institute, Salt Lake City (B.L.M.); Bayer, Berlin (S.T., I.K.); Bayer HealthCare, Whippany, NJ (R.L.); and the Division of Urology, Institut de Recherche Clinique, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, Brussels (B.T.).
ARASENS Trial Investigators
Cornell University · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI ALAN KEITH MEEKER · 1985 to 2026
$208.6M
NCI NIH HHS P30 CA006973
6 · The paper itself

Abstract

backgroundDarolutamide is a potent androgen-receptor inhibitor that has been associated with increased overall survival among patients with nonmetastatic, castration-resistant prostate cancer. Whether a combination of darolutamide, androgen-deprivation therapy, and docetaxel would increase survival among patients with metastatic, hormone-sensitive prostate cancer is unknown.

methodsIn this international, phase 3 trial, we randomly assigned patients with metastatic, hormone-sensitive prostate cancer in a 1:1 ratio to receive darolutamide (at a dose of 600 mg [two 300-mg tablets] twice daily) or matching placebo, both in combination with androgen-deprivation therapy and docetaxel. The primary end point was overall survival.

resultsThe primary analysis involved 1306 patients (651 in the darolutamide group and 655 in the placebo group); 86.1% of the patients had disease that was metastatic at the time of the initial diagnosis. At the data cutoff date for the primary analysis (October 25, 2021), the risk of death was significantly lower, by 32.5%, in the darolutamide group than in the placebo group (hazard ratio 0.68; 95% confidence interval, 0.57 to 0.80; P<0.001). Darolutamide was also associated with consistent benefits with respect to the secondary end points and prespecified subgroups. Adverse events were similar in the two groups, and the incidences of the most common adverse events (occurring in ≥10% of the patients) were highest during the overlapping docetaxel treatment period in both groups. The frequency of grade 3 or 4 adverse events was 66.1% in the darolutamide group and 63.5% in the placebo group; neutropenia was the most common grade 3 or 4 adverse event (in 33.7% and 34.2%, respectively).

conclusionsIn this trial involving patients with metastatic, hormone-sensitive prostate cancer, overall survival was significantly longer with the combination of darolutamide, androgen-deprivation therapy, and docetaxel than with placebo plus androgen-deprivation therapy and docetaxel, and the addition of darolutamide led to improvement in key secondary end points. The frequency of adverse events was similar in the two groups. (Funded by Bayer and Orion Pharma; ARASENS ClinicalTrials.gov number, NCT02799602.).

Indexed as

AgedAged, 80 and overAndrogen AntagonistsAndrogen Receptor AntagonistsAntineoplastic AgentsDocetaxelDrug Therapy, CombinationHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasm MetastasisNeutropeniaProportional Hazards ModelsProstatic NeoplasmsProstatic Neoplasms, Castration-ResistantAndrogen AntagonistsAndrogen Receptor AntagonistsAntineoplastic AgentsdarolutamideDocetaxelPyrazoles

Identifiers

PMID35179323
PMCPMC9844551
OpenAlexW4213140514

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.