En studie av Apalutamid hos deltagare med högrisk, lokaliserad eller lokalt avancerad prostatacancer som är kandidater för radikal prostatektomi (PROTEUS)
2 november 2026 uppdaterad av: Janssen Research & Development, LLC
En randomiserad, dubbelblind, placebokontrollerad, fas 3-studie av apalutamid hos personer med högrisk, lokaliserad eller lokalt avancerad prostatacancer som är kandidater för radikal prostatektomi
The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
2517
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Caba, Argentina, 1118
- Hospital Aleman
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Ciudad Autonoma de, Argentina, C1199ABB
- Hospital Italiano de Buenos Aires
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Córdoba, Argentina, X5000KPH
- Centro Urologico Profesor Bengio
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Córdoba, Argentina, X5008AAC
- Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
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Mendoza, Argentina, 5500
- Uroclinica
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San Miguel de Tucumán, Argentina, 4000
- Clinica Mayo de UMCB
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Box Hill, Australien, 3128q
- Eastern Health - Box Hill Hospital
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Darlinghurst, Australien, 2010
- St Vincent s Hospital Sydney
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Heidelberg, Australien, 3084
- Austin Health
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Malvern, Australien, 3144
- Australian Urology Associates Pty Ltd
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Parkville, Australien, 3052
- Royal Melbourne Hospital
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St Leonards, Australien, 2065
- Northern Cancer Institute
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Wahroonga, Australien, 2076
- Sydney Adventist Hospital
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Westmead, Australien, 2145
- Westmead Hospital
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Woolloongabba, Australien, 4102
- Princess Alexandra Hospital
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Goiânia, Brasilien, 74605-070
- Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
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Ijuí, Brasilien, 98700-000
- Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
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Natal, Brasilien, 59075-740
- Liga Norte Riograndense Contra O Cancer
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Porto Alegre, Brasilien, 90020-090
- Irmandade Santa Casa de Misericordia de Porto Alegre
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Rio de Janeiro, Brasilien, 20551-030
- Universidade do Estado do Rio de Janeiro - UERJ
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São Paulo, Brasilien, 01246 000
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
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São Paulo, Brasilien, 01243 020
- Hospital Samaritano de Sao Paulo
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Três Lagoas, Brasilien, 79601-001
- Instituto Do Cancer Brasil
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Angers, Frankrike, 49933
- CHU d'Angers
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Besançon, Frankrike, 25030
- CHRU Besancon Hopital Jean Minjoz
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Bordeaux, Frankrike, 33076
- Hopital Pellegrin CHU Bordeaux
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Créteil, Frankrike, 94010
- APHP - Hopital Henri Mondor
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Lyon, Frankrike, 69437
- Hopital Edouard Herriot - CHU Lyon
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Nantes, Frankrike, 44000
- CHU de Nantes hotel Dieu
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Paris, Frankrike, 75014
- Institut Mutualiste Montsouris
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Quint-Fonsegrives, Frankrike, 31130
- Clinique de la Croix du Sud
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Rennes, Frankrike, 35033
- Chu Rennes Hopital Pontchaillou
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Toulouse, Frankrike, 31059
- CHU de Toulouse - Hôpital Rangueil
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Tours, Frankrike, 37000
- CHRU Tours Hopital Bretonneau
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California
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La Jolla, California, Förenta staterna, 92093
- UC San Diego Moores Cancer Center
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Los Angeles, California, Förenta staterna, 90033
- University of Southern California
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Los Angeles, California, Förenta staterna, 90095
- University of California Los Angeles
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Los Angeles, California, Förenta staterna, 90048
- Cedars Sinai Medical Center
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Orange, California, Förenta staterna, 92868
- University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
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Sacramento, California, Förenta staterna, 95817
- UC Davis Medical Center
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Colorado
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Denver, Colorado, Förenta staterna, 80210
- AdventHealth Medical Group Urology of Denver
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Lakewood, Colorado, Förenta staterna, 80228
- Colorado Clinical Research
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Connecticut
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Stamford, Connecticut, Förenta staterna, 06904
- Stamford Hospital
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Florida
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Hialeah, Florida, Förenta staterna, 33002
- Urology Specialists LLC
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Jacksonville, Florida, Förenta staterna, 32224
- Mayo Clinic - Division Of Hematology/oncology
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Miami, Florida, Förenta staterna, 33176
- Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
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Orlando, Florida, Förenta staterna, 32804
- Advent Health
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322-1013
- Emory University Winship Cancer Institute
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Illinois
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Chicago, Illinois, Förenta staterna, 60637
- University of Chicago
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Louisiana
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Shreveport, Louisiana, Förenta staterna, 71106
- Ochsner LSU Health Shreveport - Regional Urology
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Dana Farber Cancer Institute
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Boston, Massachusetts, Förenta staterna, 02215
- Beth Isreal Deaconess Medical Center
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Michigan
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Troy, Michigan, Förenta staterna, 48084
- Michigan Institute of Urology, PC
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Missouri
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St Louis, Missouri, Förenta staterna, 63110
- Saint Louis University
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68130
- Urology Cancer Center, PC
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New York
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Albany, New York, Förenta staterna, 12208
- Albany Medical College
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Cheektowaga, New York, Förenta staterna, 14225
- Great Lakes Physician PC d/b/a Western New York Urology Associates
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New York, New York, Förenta staterna, 10065
- Weill Cornell Medical College
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New York, New York, Förenta staterna, 10065
- Memorial Sloan-Kettering Cancer Center
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Syracuse, New York, Förenta staterna, 13210
- SUNY Upstate Medical University
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27599
- University of North Carolina
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Durham, North Carolina, Förenta staterna, 27705
- Duke University School of Medicine
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Greensboro, North Carolina, Förenta staterna, 27403
- Medication Management LLC
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Huntersville, North Carolina, Förenta staterna, 28078
- Carolina Urology Partners, PLLC
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Ohio
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Cleveland, Ohio, Förenta staterna, 44106
- Cleveland VA Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- Oklahoma City VAMC
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, Förenta staterna, 19004
- MidLantic Urology
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Rhode Island
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Warwick, Rhode Island, Förenta staterna, 02886
- Omega Medical Research
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29403
- Medical University of South Carolina
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Charleston, South Carolina, Förenta staterna, 29401
- Ralph H. Johnson Veterans Affairs Medical Center
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Greenville, South Carolina, Förenta staterna, 29605
- Greenville Health
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Myrtle Beach, South Carolina, Förenta staterna, 29572
- Carolina Urologic Research Center
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Förenta staterna, 75216
- VA North Texas Health Care System
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Houston, Texas, Förenta staterna, 77030
- MD Anderson Cancer Center
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Virginia
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Richmond, Virginia, Förenta staterna, 23235
- Virginia Urology
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Virginia Beach, Virginia, Förenta staterna, 23462
- Urology of Virginia, PLCC
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West Virginia
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Charleston, West Virginia, Förenta staterna, 25304
- CAMC Memorial Hospital, Charleston Area Medical Center Physicians
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Beer Yaakov, Israel, 60930
- Asaf Harofe Medical Center
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Haifa, Israel, 31096
- Rambam Health Care Campus
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Kfar Saba, Israel, 4428164
- Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC)
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Petah Tikva, Israel, 49100
- Rabin Medical Center
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Ramat Gan, Israel, 52621
- The Chaim Sheba Medical Center
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Center
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Abano Terme, Italien, 35031
- Policlinico Abano Terme
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Acquaviva delle Fonti, Italien, 70021
- Generale Regionale F. Miulli
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Bassano del Grappa, Italien, 36061
- Ospedale di Bassano del Grappa
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Brescia, Italien, 25123
- ASST Spedali Civili Brescia
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Chieti, Italien, 66100
- ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti
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Florence, Italien, 50134
- Azienda Ospedaliero Universitaria Careggi
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Milan, Italien, 20132
- Ospedale San Raffaele
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Milan, Italien, 20141
- Istituto Europeo di Oncologia
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Milan, Italien, 20127
- San Raffaele Turro - Istituto di Ricovero e Cura a Carattere Scientifico
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Modena, Italien, 41100
- Clinica di Urologia Policlinico di Modena - Universita di Modena e reggio Emilia
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Novara, Italien, 28100
- Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara
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Orbassano, Italien, 10043
- Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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Roma, Italien, 00144
- Istituto Nazionale Tumori Regina Elena
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Roma, Italien, 00189
- Azienda Ospedaliera Sant Andrea
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Roma, Italien, 00128
- Universita Campus Bio-Medico di Roma
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Torino, Italien, 10126
- Ospedale Molinette, AO Città della Salute e della Scienza di
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Verona, Italien, 37126
- UOC di Urologia AOU Integrata di Verona - Polo Chirurgico Confortini - Ospedale Borgo Trento
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Akita, Japan, 010-8543
- Akita University Hospital
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Chiba, Japan, 260 8677
- Chiba University Hospital
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Chūōku, Japan, 260-8717
- Chiba Cancer Center
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Hakodate, Japan, 040 8611
- Hakodate Goryoukaku Hospital
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Hirosaki, Japan, 036-8203
- Hirosaki University Hospital
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Kanazawa, Japan, 920 8641
- Kanazawa University Hospital
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Kobe, Japan, 650-0047
- Kobe City Medical Center General Hospital
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Koshigaya, Japan, 343-8555
- Dokkyo Medical University Saitama Medical Center
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Kurume, Japan, 830-0011
- Kurume University Hospital
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Kyoto, Japan, 606-8507
- Kyoto University Hospital
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Matsuyama, Japan, 791-0280
- National Hospital Organization Shikoku Cancer Center
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Minamiku, Japan, 252-0375
- Kitasato University Hospital
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Miyazaki, Japan, 889-1692
- University of Miyazaki Hospital
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Nagano, Japan, 381-8551
- Nagano Municipal Hospital
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Osaka, Japan, 541 8567
- Osaka International Cancer Institute
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Sakai, Japan, 590 0197
- Kindai University Hospital
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Sakura, Japan, 285-8741
- Toho University Sakura Medical Center
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Sapporo, Japan, 060-8648
- Hokkaido University Hospital
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Shiwa-gun, Japan, 028-3695
- Iwate Medical University Hospital
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Tokyo, Japan, 113-8421
- Juntendo University Hospital
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Tokyo, Japan, 113 8603
- Nippon Medical School Hospital
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Ube, Japan, 755-8505
- Yamaguchi University Hospital
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Yokohama, Japan, 232 0024
- Yokohama City University Medical Center
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Alberta
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Calgary, Alberta, Kanada, T2V 1P9
- Prostate Cancer Centre
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 1M9
- Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 2Y9
- Nova Scotia Health Authority
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Ontario
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London, Ontario, Kanada, N6A 5W9
- London Health Sciences Center
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Toronto, Ontario, Kanada, M5G2M9
- Princess Margaret Cancer Centre University Health Network
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Toronto, Ontario, Kanada, M4N 3M5
- Sunnybrook Health Sciences Center
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Quebec
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Montreal, Quebec, Kanada, H2X 0A9
- CHUM - Centre hospitalier universitaire de Montreal
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Québec, Quebec, Kanada, G1R 2J6
- CHU de Quebec Universite Laval Hopital de l Enfant Jesus
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Amsterdam, Nederländerna, 1066 CX
- Antoni van Leeuwenhoek
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Eindhoven, Nederländerna, 5623 EJ
- Catharinaziekenhuis
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Nieuwegein, Nederländerna, 3430EM
- St. Antonius Ziekenhuis (St. Antonius Hospital)
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Nijmegen, Nederländerna, 6524 KD
- Canisius-Wilhelmina Ziekenhuis
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Bydgoszcz, Polen, 85 094
- Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
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Bydgoszcz, Polen, 85 015
- Samodzielny Publiczny Wielospecjalistyczny Zaklad Opieki Zdrowotnej Mswia W Bydgoszczy
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Koszalin, Polen, 75 581
- Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie
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Krakow, Polen, 30-727
- Pratia MCM Krakow
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Warsaw, Polen, 02-473
- City Clinic Sp. z o.o.
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Wroclaw, Polen, 53-413
- Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - Urologia
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Barnaul, Ryssland, 656049
- Altai Regional Oncology Dispensary
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Chelyabinsk, Ryssland, 454087
- Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
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Moscow, Ryssland, 125284
- Hertzen Oncology Research Institute
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Moscow, Ryssland, 121205
- Moscow City Oncology Hospital No 62
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Omsk, Ryssland, 644013
- Clinical Oncology Dispensary
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Tyumen, Ryssland, 625000
- Medical-sanitary unit 'Neftyanik'
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Vologda, Ryssland, 160012
- Vologda Regional Oncological Dispensary
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A Coruña, Spanien, 15006
- Hosp Univ A Coruna
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Barcelona, Spanien, 8035
- Hosp Univ Vall D Hebron
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Cadiz, Spanien, 11009
- Hosp. Puerta Del Mar
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Castellon, Spanien, 12004
- Hosp. Gral. Univ. de Castellon
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Jerez de la Frontera, Spanien, 11407
- Hosp. de Jerez de La Frontera
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Madrid, Spanien, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Spanien, 28034
- Hosp. Univ. Ramon Y Cajal
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Madrid, Spanien, 28046
- Hosp. Univ. La Paz
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Manacor, Spanien, 07500
- Fund. Hosp. de Manacor
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Málaga, Spanien, 29010
- Hosp Virgen de La Victoria
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Santander, Spanien, 39008
- Hosp. Univ. Marques de Valdecilla
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Seville, Spanien, 41013
- Hosp. Virgen Del Rocio
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Valencia, Spanien, 46009
- Inst. Valenciano de Oncologia
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Valencia, Spanien, 46010
- Hosp. Clinico Univ. de Valencia
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Bristol, Storbritannien, BS10 5NB
- Southmead Hospital
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Cardiff, Storbritannien, CF14 4XW
- University Hospital of Wales
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Dundee, Storbritannien, DD2 1UB
- Ninewells Hospital
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London, Storbritannien, WC1E 6BT
- University College London
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London, Storbritannien, SW3 6JJ
- The Royal Marsden NHS Trust
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Preston, Storbritannien, PR2 9HT
- Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
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Sutton, Storbritannien, SM2 5PT
- Royal Marsden Hospital
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Wakefield, Storbritannien, WF1 4DG
- Mid Yorkshire NHS Trust
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Wolverhampton, Storbritannien, WV10 0QP
- New Cross Hospital
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Gwangju, Sydkorea, 61469
- Chonnam National University Hospital
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Gyeonggi-do, Sydkorea, 13605
- Seoul National University Bundang Hospital
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Seoul, Sydkorea, 05505
- Asan Medical Center
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Seoul, Sydkorea, 03722
- Severance Hospital Yonsei University Health System
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Seoul, Sydkorea, 06591
- The Catholic University of Korea Seoul St Marys Hospital
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Seoul, Sydkorea, 05505
- Asan Medical Center 1
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Kaohsiung City, Taiwan, 807
- Kaohsiung Medical University Chung Ho Memorial Hospital
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Taichung, Taiwan, 40447
- China Medical University Hospital
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Taichung, Taiwan, 435
- Tungs' Taichung MetroHarbor Hospital
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Tainan, Taiwan, 710
- Chi Mei Medical Center Yong Kang
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Hradec Králove, Tjeckien, 500 05
- Fakultni nemocnice Hradec Kralove
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Liberec, Tjeckien, 460 63
- Krajská nemocnice Liberec
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Olomouc, Tjeckien, 77200
- Uromedical Center s.r.o.
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Pilsen, Tjeckien, 305 99
- Fakultni nemocnice Plzen, Urologicka klinika
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Prague, Tjeckien, 140 59
- Thomayerova nemocnice
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Prague, Tjeckien, 120 00
- Vseobecna fakultni nemocnice v Praze
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Aachen, Tyskland, 52074
- Universitaetsklinikum der RWTH Aachen
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Braunschweig, Tyskland, 38126
- Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie
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Cologne, Tyskland, 50937
- Universitaetsklinikum Koelnt
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Eisleben Lutherstadt, Tyskland, 06295
- Praxis Dr. med. Ralf Eckert
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Essen, Tyskland, 45147
- Universitatsklinikum Essen
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Frankfurt am Main, Tyskland, 60590
- Universitatsklinikum Frankfurt
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Gronau, Tyskland, 48599
- Prostata zentrum Nordwest
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Hamburg, Tyskland, 20246
- Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie
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Homburg/Saar, Tyskland, 66421
- Universitätsklinikum des Saarlandes
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Lübeck, Tyskland, 23538
- Universitatsklinikum Schleswig Holstein Campus Lubeck
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Straubing, Tyskland, 94315
- Klinikum St. Elisabeth Straubing GmbH
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Weiden/Opf, Tyskland, 92637
- Kliniken Nordoberpfalz, Klinik für Urologie
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Wilhelmshaven, Tyskland, 26389
- Praxisgemeinschaft f. Onkologie u. Urologie - Germany
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate
- High-risk disease defined by a total Gleason Sum Score greater than equal to (>=) 4+3 (=Grade Groups [GG] 3-5) and >=1 of the following 4 criteria: a) Any combination of Gleason Score 4+3 (= 3) and Gleason Score 8 (4+4 or 5+3) in >= 6 systematic cores (with >=1 core Gleason Score 8 [4+4 or 5+3] included); b) Any combination of Gleason Score 4+3 (=GG 3) and Gleason Score 8 (4+4 or 5+3) in >=3 systematic cores and Prostate-specific antigen (PSA) >=20 ng/mL (with >= 1 core Gleason Score 8 [4+4 or 5+3] included); c) Gleason Score >=9 (=GG 5) in at least 1 systematic or targeted core; d) At least 2 systematic or targeted cores with continuous Gleason Score >=8 (=GG 4), each with > 80 percent (%) involvement
- Candidate for radical prostatectomy with pelvic lymph node dissection as per the investigator
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Contraceptive use by male participants (and female partners of male participants enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
- Able to receive androgen deprivation therapy (ADT) for at least 13 months
Exclusion Criteria:
- Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Participants are considered eligible only if the central radiological review confirms clinical stage M0
- (a) Prior treatment with androgen receptor antagonists; (b) Treatment with gonadotropin-releasing hormone analog (GnRHa) prior to informed consent form (ICF) signature
- History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer
- Use of any investigational agent less than or equals to (<=)4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time
- Major surgery <=4 weeks prior to randomization
- Any of the following within 12 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (example, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Apalutamide + ADT
Participants will receive androgen deprivation therapy (ADT) plus oral administration of apalutamide 240 milligram (mg) (4 tablets of 60 mg each) daily in each cycle (each cycle of 28 days). Participants will receive six cycles of treatment, followed by radical prostatectomy (RP) with pelvic lymph node dissection (pLND), followed by an additional six cycles of treatment. A Long-Term Extension (LTE) may be initiated at sponsor's discretion after completion of the primary endpoint analysis. |
Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.
Andra namn:
Participants will receive a stable regimen of ADT - gonadotropin-releasing hormone analog (agonist or antagonist) (GnRHa). ADT is a kind of hormone therapy for prostate cancer. GnRHa will be administrated to achieve and maintain sub-castrate concentrations of testosterone (50 nanogram per deciliter [ng/dL]). |
|
Experimentell: Placebo + ADT
Participants will receive ADT with oral administration of matching placebo treatment daily in each cycle (each cycle of 28 days). Participants will receive six cycles of placebo treatment, followed by RP with pLND, followed by an additional six cycles of placebo treatment. A LTE may be initiated at sponsor's discretion after completion of the primary endpoint analysis. |
Participants will receive a stable regimen of ADT - gonadotropin-releasing hormone analog (agonist or antagonist) (GnRHa). ADT is a kind of hormone therapy for prostate cancer. GnRHa will be administrated to achieve and maintain sub-castrate concentrations of testosterone (50 nanogram per deciliter [ng/dL]). Participants will receive matching placebo oral tablets daily. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants with Pathologic complete response (pCR)
Tidsram: Approximately 4 years
|
pCR is assessed by a pathology blinded independent central radiology review (BICR) as defined in the pathology charter. |
Approximately 4 years
|
|
Metastasis-Free Survival (MFS)
Tidsram: Up to 7 years and 5 months
|
MFS is defined as the time from randomization to the date of the occurrence of radiographic distant metastasis evaluated by radiology BICR, incidental pathologic finding of distant metastasis, or death from any cause, whichever occurs first. |
Up to 7 years and 5 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Prostate Specific Antigen (PSA)-Free Survival
Tidsram: Approximately 4 years
|
PSA-free survival with testosterone recovery defined as the time from randomization to the first detectable serum PSA level with recovered testosterone levels after undetectable PSA post-radical prostatectomy with pelvic lymph node dissection or death, whichever occurs first. |
Approximately 4 years
|
|
Event Free Survival (EFS)
Tidsram: Up to 7 years and 5 months
|
EFS defined as time from randomization to any of the following events: biochemical failure (BCF); or local or regional recurrence by BICR or histopathological assessment; or distant metastasis by BICR or histopathological assessment; or death. |
Up to 7 years and 5 months
|
|
Time to Subsequent First Treatments (TTST-1)
Tidsram: Up to 7 years and 5 months
|
TTST-1 is defined as the time from randomization to the date of first subsequent therapy. |
Up to 7 years and 5 months
|
|
Time to Distant Metastasis (TTDM)
Tidsram: Up to 7 years and 5 months
|
TTDM is defined as the time from the date of enrollment until the first date of distant metastasis. |
Up to 7 years and 5 months
|
|
MFS Based on Conventional Imaging
Tidsram: Up to 7 years and 5 months
|
MFS based on conventional imaging, defined as the time from randomization to the date of the first occurrence of radiographic distant metastasis on CT/MRI and bone scan by radiology BICR, pathologic finding of distant metastasis, or death from any cause, whichever occurs first. |
Up to 7 years and 5 months
|
|
Number of Participants with No Evidence of Disease (NED) at 4 Years
Tidsram: Up to 4 years
|
Number of participants with NED at 4 years will be reported. NED at 4 years is defined as: (a) alive, (b) Undetectable prostate-specific antigen (PSA), (c) No distant metastasis, (d) No local or regional recurrence, (e) No subsequent therapy for prostate cancer, (f) Testosterone recovery to physiological testosterone levels, defined as 200 nanograms per deciliter (ng/dL). |
Up to 4 years
|
|
Number of Participants with Vital Signs Abnormalities as a Measure of Safety and Tolerability
Tidsram: Up to 30 days after last dose of study drug (Approximately 8 years)
|
Number of participants with vital signs (including body temperature, heart rate, respiratory rate, and blood pressure) abnormalities will be reported. |
Up to 30 days after last dose of study drug (Approximately 8 years)
|
|
Number of Participants with Physical Examinations Abnormalities as a Measure of Safety and Tolerability
Tidsram: Up to 30 days after last dose of study drug (Approximately 8 years)
|
Number of participants with physical examinations (including general appearance of the participant, height, weight, and examination of the skin, ears, nose, throat, lungs, heart, abdomen, extremities, musculoskeletal system, lymphatic system, and nervous system) abnormalities will be reported. |
Up to 30 days after last dose of study drug (Approximately 8 years)
|
|
Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability
Tidsram: Up to 30 days after last dose of study drug (Approximately 8 years)
|
Blood samples for serum chemistry and hematology will be collected at predefined time points for clinical laboratory testing. |
Up to 30 days after last dose of study drug (Approximately 8 years)
|
|
Number of Participants with Treatment Compliance Rate
Tidsram: Up to 30 days after last dose of study drug (Approximately 8 years)
|
Number of participants who are complaint with study treatment will be assessed. |
Up to 30 days after last dose of study drug (Approximately 8 years)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Ravi P, Kwak L, Xie W, Kelleher K, Acosta AM, McKay RR, Kibel AS, Taplin ME. Neoadjuvant Novel Hormonal Therapy Followed by Prostatectomy versus Up-Front Prostatectomy for High-Risk Prostate Cancer: A Comparative Analysis. J Urol. 2022 Oct;208(4):838-845. doi: 10.1097/JU.0000000000002803. Epub 2022 Sep 9.
- Taplin ME, Gleave M, Shore ND, Lopez-Gitlitz A, Kretschmer A, Efstathiou E, Nguyen PL, Damiao R, Kamoto T, Ross A, Briganti A, Hadaschik BA, Heidenreich A, Juarez Soto A, Ye H, Gotto G, Rooney B, Tian SK, Wetherhold L, Miladinovic B, McCarthy SA, Evans CP, Kibel AS; PROTEUS Investigators. Perioperative Apalutamide in High-Risk Localized Prostate Cancer. N Engl J Med. 2026 Aug 6;395(6):546-560. doi: 10.1056/NEJMoa2603878. Epub 2026 May 31.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 juni 2019
Primärt slutförande (Beräknad)
1 december 2026
Avslutad studie (Beräknad)
13 oktober 2028
Studieregistreringsdatum
Först inskickad
5 december 2018
Först inskickad som uppfyllde QC-kriterierna
5 december 2018
Första postat (Faktisk)
6 december 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 november 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 november 2026
Senast verifierad
1 november 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Genitala neoplasmer, manliga
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Genitala sjukdomar, manliga
- Prostatasjukdomar
- Manliga urogenitala sjukdomar
- Prostatiska neoplasmer
- Läkemedels fysiologiska effekter
- Hormoner, hormonsubstitut och hormonantagonister
- Hormonantagonister
- Farmakologiska åtgärder
- Kemiska åtgärder och användningar
- Androgenantagonister
- apalutamid
Andra studie-ID-nummer
- CR108535
- 2018 (U.S.S. NIH-anslag/kontrakt)
- 56021927PCR3011 (Annan identifierare: Janssen Research & Development, LLC)
- 2018-001746-34 (EudraCT-nummer)
- 2023-506153-38-00 (Registeridentifierare: EUCT number)
- 2023 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .