En studie av apalutamid hos deltakere med høyrisiko, lokalisert eller lokalt avansert prostatakreft som er kandidater for radikal prostatektomi (PROTEUS)
2. november 2026 oppdatert av: Janssen Research & Development, LLC
En randomisert, dobbeltblind, placebokontrollert, fase 3-studie av apalutamid hos personer med høyrisiko, lokalisert eller lokalt avansert prostatakreft som er kandidater for 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
2517
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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, Australia, 3128q
- Eastern Health - Box Hill Hospital
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Darlinghurst, Australia, 2010
- St Vincent s Hospital Sydney
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Heidelberg, Australia, 3084
- Austin Health
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Malvern, Australia, 3144
- Australian Urology Associates Pty Ltd
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Parkville, Australia, 3052
- Royal Melbourne Hospital
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St Leonards, Australia, 2065
- Northern Cancer Institute
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Wahroonga, Australia, 2076
- Sydney Adventist Hospital
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Westmead, Australia, 2145
- Westmead Hospital
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Woolloongabba, Australia, 4102
- Princess Alexandra Hospital
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Goiânia, Brasil, 74605-070
- Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
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Ijuí, Brasil, 98700-000
- Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
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Natal, Brasil, 59075-740
- Liga Norte Riograndense Contra O Cancer
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Porto Alegre, Brasil, 90020-090
- Irmandade Santa Casa de Misericordia de Porto Alegre
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Rio de Janeiro, Brasil, 20551-030
- Universidade do Estado do Rio de Janeiro - UERJ
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São Paulo, Brasil, 01246 000
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
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São Paulo, Brasil, 01243 020
- Hospital Samaritano de Sao Paulo
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Três Lagoas, Brasil, 79601-001
- Instituto Do Cancer Brasil
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Alberta
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Calgary, Alberta, Canada, T2V 1P9
- Prostate Cancer Centre
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British Columbia
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Vancouver, British Columbia, Canada, 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, Canada, B3H 2Y9
- Nova Scotia Health Authority
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Ontario
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London, Ontario, Canada, N6A 5W9
- London Health Sciences Center
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Toronto, Ontario, Canada, M5G2M9
- Princess Margaret Cancer Centre University Health Network
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Center
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Quebec
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Montreal, Quebec, Canada, H2X 0A9
- CHUM - Centre hospitalier universitaire de Montreal
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Québec, Quebec, Canada, G1R 2J6
- CHU de Quebec Universite Laval Hopital de l Enfant Jesus
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California
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La Jolla, California, Forente stater, 92093
- UC San Diego Moores Cancer Center
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Los Angeles, California, Forente stater, 90033
- University of Southern California
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Los Angeles, California, Forente stater, 90095
- University of California Los Angeles
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Los Angeles, California, Forente stater, 90048
- Cedars Sinai Medical Center
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Orange, California, Forente stater, 92868
- University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
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Sacramento, California, Forente stater, 95817
- UC Davis Medical Center
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Colorado
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Denver, Colorado, Forente stater, 80210
- AdventHealth Medical Group Urology of Denver
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Lakewood, Colorado, Forente stater, 80228
- Colorado Clinical Research
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Connecticut
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Stamford, Connecticut, Forente stater, 06904
- Stamford Hospital
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Florida
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Hialeah, Florida, Forente stater, 33002
- Urology Specialists LLC
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Jacksonville, Florida, Forente stater, 32224
- Mayo Clinic - Division Of Hematology/oncology
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Miami, Florida, Forente stater, 33176
- Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
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Orlando, Florida, Forente stater, 32804
- Advent Health
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Georgia
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Atlanta, Georgia, Forente stater, 30322-1013
- Emory University Winship Cancer Institute
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Illinois
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Chicago, Illinois, Forente stater, 60637
- University of Chicago
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Louisiana
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Shreveport, Louisiana, Forente stater, 71106
- Ochsner LSU Health Shreveport - Regional Urology
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Dana Farber Cancer Institute
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Boston, Massachusetts, Forente stater, 02215
- Beth Isreal Deaconess Medical Center
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Michigan
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Troy, Michigan, Forente stater, 48084
- Michigan Institute of Urology, PC
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Missouri
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St Louis, Missouri, Forente stater, 63110
- Saint Louis University
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Nebraska
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Omaha, Nebraska, Forente stater, 68130
- Urology Cancer Center, PC
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New York
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Albany, New York, Forente stater, 12208
- Albany Medical College
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Cheektowaga, New York, Forente stater, 14225
- Great Lakes Physician PC d/b/a Western New York Urology Associates
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New York, New York, Forente stater, 10065
- Weill Cornell Medical College
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New York, New York, Forente stater, 10065
- Memorial Sloan-Kettering Cancer Center
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Syracuse, New York, Forente stater, 13210
- SUNY Upstate Medical University
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599
- University of North Carolina
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Durham, North Carolina, Forente stater, 27705
- Duke University School of Medicine
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Greensboro, North Carolina, Forente stater, 27403
- Medication Management LLC
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Huntersville, North Carolina, Forente stater, 28078
- Carolina Urology Partners, PLLC
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- Cleveland VA Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- Oklahoma City VAMC
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, Forente stater, 19004
- MidLantic Urology
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Rhode Island
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Warwick, Rhode Island, Forente stater, 02886
- Omega Medical Research
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South Carolina
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Charleston, South Carolina, Forente stater, 29403
- Medical University of South Carolina
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Charleston, South Carolina, Forente stater, 29401
- Ralph H. Johnson Veterans Affairs Medical Center
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Greenville, South Carolina, Forente stater, 29605
- Greenville Health
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Myrtle Beach, South Carolina, Forente stater, 29572
- Carolina Urologic Research Center
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Tennessee
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Nashville, Tennessee, Forente stater, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Forente stater, 75216
- VA North Texas Health Care System
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Houston, Texas, Forente stater, 77030
- MD Anderson Cancer Center
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Virginia
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Richmond, Virginia, Forente stater, 23235
- Virginia Urology
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Virginia Beach, Virginia, Forente stater, 23462
- Urology of Virginia, PLCC
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West Virginia
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Charleston, West Virginia, Forente stater, 25304
- CAMC Memorial Hospital, Charleston Area Medical Center Physicians
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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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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, Italia, 35031
- Policlinico Abano Terme
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Acquaviva delle Fonti, Italia, 70021
- Generale Regionale F. Miulli
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Bassano del Grappa, Italia, 36061
- Ospedale di Bassano del Grappa
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Brescia, Italia, 25123
- ASST Spedali Civili Brescia
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Chieti, Italia, 66100
- ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti
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Florence, Italia, 50134
- Azienda Ospedaliero Universitaria Careggi
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Milan, Italia, 20132
- Ospedale San Raffaele
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Milan, Italia, 20141
- Istituto Europeo di Oncologia
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Milan, Italia, 20127
- San Raffaele Turro - Istituto di Ricovero e Cura a Carattere Scientifico
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Modena, Italia, 41100
- Clinica di Urologia Policlinico di Modena - Universita di Modena e reggio Emilia
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Novara, Italia, 28100
- Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara
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Orbassano, Italia, 10043
- Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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Roma, Italia, 00144
- Istituto Nazionale Tumori Regina Elena
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Roma, Italia, 00189
- Azienda Ospedaliera Sant Andrea
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Roma, Italia, 00128
- Universita Campus Bio-Medico di Roma
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Torino, Italia, 10126
- Ospedale Molinette, AO Città della Salute e della Scienza di
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Verona, Italia, 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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Amsterdam, Nederland, 1066 CX
- Antoni van Leeuwenhoek
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Eindhoven, Nederland, 5623 EJ
- Catharinaziekenhuis
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Nieuwegein, Nederland, 3430EM
- St. Antonius Ziekenhuis (St. Antonius Hospital)
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Nijmegen, Nederland, 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, Russland, 656049
- Altai Regional Oncology Dispensary
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Chelyabinsk, Russland, 454087
- Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
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Moscow, Russland, 125284
- Hertzen Oncology Research Institute
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Moscow, Russland, 121205
- Moscow City Oncology Hospital No 62
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Omsk, Russland, 644013
- Clinical Oncology Dispensary
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Tyumen, Russland, 625000
- Medical-sanitary unit 'Neftyanik'
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Vologda, Russland, 160012
- Vologda Regional Oncological Dispensary
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A Coruña, Spania, 15006
- Hosp Univ A Coruna
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Barcelona, Spania, 8035
- Hosp Univ Vall D Hebron
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Cadiz, Spania, 11009
- Hosp. Puerta Del Mar
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Castellon, Spania, 12004
- Hosp. Gral. Univ. de Castellon
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Jerez de la Frontera, Spania, 11407
- Hosp. de Jerez de La Frontera
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Madrid, Spania, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Spania, 28034
- Hosp. Univ. Ramon Y Cajal
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Madrid, Spania, 28046
- Hosp. Univ. La Paz
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Manacor, Spania, 07500
- Fund. Hosp. de Manacor
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Málaga, Spania, 29010
- Hosp Virgen de La Victoria
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Santander, Spania, 39008
- Hosp. Univ. Marques de Valdecilla
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Seville, Spania, 41013
- Hosp. Virgen Del Rocio
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Valencia, Spania, 46009
- Inst. Valenciano de Oncologia
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Valencia, Spania, 46010
- Hosp. Clinico Univ. de Valencia
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Bristol, Storbritannia, BS10 5NB
- Southmead Hospital
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Cardiff, Storbritannia, CF14 4XW
- University Hospital of Wales
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Dundee, Storbritannia, DD2 1UB
- Ninewells Hospital
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London, Storbritannia, WC1E 6BT
- University College London
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London, Storbritannia, SW3 6JJ
- The Royal Marsden NHS Trust
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Preston, Storbritannia, PR2 9HT
- Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
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Sutton, Storbritannia, SM2 5PT
- Royal Marsden Hospital
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Wakefield, Storbritannia, WF1 4DG
- Mid Yorkshire NHS Trust
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Wolverhampton, Storbritannia, WV10 0QP
- New Cross Hospital
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Gwangju, Sør -Korea, 61469
- Chonnam National University Hospital
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Gyeonggi-do, Sør -Korea, 13605
- Seoul National University Bundang Hospital
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Seoul, Sør -Korea, 05505
- Asan Medical Center
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Seoul, Sør -Korea, 03722
- Severance Hospital Yonsei University Health System
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Seoul, Sør -Korea, 06591
- The Catholic University of Korea Seoul St Marys Hospital
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Seoul, Sør -Korea, 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, Tsjekkia, 500 05
- Fakultni nemocnice Hradec Kralove
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Liberec, Tsjekkia, 460 63
- Krajská nemocnice Liberec
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Olomouc, Tsjekkia, 77200
- Uromedical Center s.r.o.
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Pilsen, Tsjekkia, 305 99
- Fakultni nemocnice Plzen, Urologicka klinika
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Prague, Tsjekkia, 140 59
- Thomayerova nemocnice
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Prague, Tsjekkia, 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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
Andre navn:
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]). |
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants with Pathologic complete response (pCR)
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prostate Specific Antigen (PSA)-Free Survival
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
11. juni 2019
Primær fullføring (Antatt)
1. desember 2026
Studiet fullført (Antatt)
13. oktober 2028
Datoer for studieregistrering
Først innsendt
5. desember 2018
Først innsendt som oppfylte QC-kriteriene
5. desember 2018
Først lagt ut (Faktiske)
6. desember 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. november 2026
Sist bekreftet
1. november 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Genitale neoplasmer, hanner
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Kjønnssykdommer, mannlige
- Prostata sykdommer
- Mannlige urogenitale sykdommer
- Prostatiske neoplasmer
- Fysiologiske effekter av legemidler
- Hormoner, hormonsubstitutter og hormonantagonister
- Hormonantagonister
- Farmakologiske handlinger
- Kjemiske handlinger og bruk
- Androgenantagonister
- apalutamid
Andre studie-ID-numre
- CR108535
- 2018 (U.S. NIH-stipend/kontrakt)
- 56021927PCR3011 (Annen identifikator: Janssen Research & Development, LLC)
- 2018-001746-34 (EudraCT-nummer)
- 2023-506153-38-00 (Registeridentifikator: EUCT number)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .