En undersøgelse af apalutamid hos deltagere med højrisiko, lokaliseret eller lokalt avanceret prostatacancer, som er kandidater til radikal prostatektomi (PROTEUS)
2. november 2026 opdateret af: Janssen Research & Development, LLC
Et randomiseret, dobbeltblindt, placebokontrolleret, fase 3-studie af apalutamid hos personer med højrisiko, lokaliseret eller lokalt avanceret prostatacancer, som er kandidater til 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.
Studieoversigt
Status
Status
Aktiv, ikke rekrutterende
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
2517
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
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, 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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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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Bristol, Det Forenede Kongerige, BS10 5NB
- Southmead Hospital
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Cardiff, Det Forenede Kongerige, CF14 4XW
- University Hospital of Wales
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Dundee, Det Forenede Kongerige, DD2 1UB
- Ninewells Hospital
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London, Det Forenede Kongerige, WC1E 6BT
- University College London
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London, Det Forenede Kongerige, SW3 6JJ
- The Royal Marsden NHS Trust
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Preston, Det Forenede Kongerige, PR2 9HT
- Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
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Sutton, Det Forenede Kongerige, SM2 5PT
- Royal Marsden Hospital
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Wakefield, Det Forenede Kongerige, WF1 4DG
- Mid Yorkshire NHS Trust
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Wolverhampton, Det Forenede Kongerige, WV10 0QP
- New Cross Hospital
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California
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La Jolla, California, Forenede Stater, 92093
- UC San Diego Moores Cancer Center
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Los Angeles, California, Forenede Stater, 90033
- University of Southern California
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Los Angeles, California, Forenede Stater, 90095
- University of California Los Angeles
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Los Angeles, California, Forenede Stater, 90048
- Cedars Sinai Medical Center
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Orange, California, Forenede Stater, 92868
- University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
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Sacramento, California, Forenede Stater, 95817
- UC Davis Medical Center
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Colorado
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Denver, Colorado, Forenede Stater, 80210
- AdventHealth Medical Group Urology of Denver
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Lakewood, Colorado, Forenede Stater, 80228
- Colorado Clinical Research
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Connecticut
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Stamford, Connecticut, Forenede Stater, 06904
- Stamford Hospital
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Florida
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Hialeah, Florida, Forenede Stater, 33002
- Urology Specialists LLC
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Jacksonville, Florida, Forenede Stater, 32224
- Mayo Clinic - Division Of Hematology/oncology
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Miami, Florida, Forenede Stater, 33176
- Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
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Orlando, Florida, Forenede Stater, 32804
- Advent Health
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322-1013
- Emory University Winship Cancer Institute
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago
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Louisiana
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Shreveport, Louisiana, Forenede Stater, 71106
- Ochsner LSU Health Shreveport - Regional Urology
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Dana Farber Cancer Institute
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Boston, Massachusetts, Forenede Stater, 02215
- Beth Isreal Deaconess Medical Center
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Michigan
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Troy, Michigan, Forenede Stater, 48084
- Michigan Institute of Urology, PC
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Saint Louis University
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68130
- Urology Cancer Center, PC
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New York
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Albany, New York, Forenede Stater, 12208
- Albany Medical College
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Cheektowaga, New York, Forenede Stater, 14225
- Great Lakes Physician PC d/b/a Western New York Urology Associates
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New York, New York, Forenede Stater, 10065
- Weill Cornell Medical College
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New York, New York, Forenede Stater, 10065
- Memorial Sloan-Kettering Cancer Center
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Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Medical University
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- University of North Carolina
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Durham, North Carolina, Forenede Stater, 27705
- Duke University School of Medicine
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Greensboro, North Carolina, Forenede Stater, 27403
- Medication Management LLC
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Huntersville, North Carolina, Forenede Stater, 28078
- Carolina Urology Partners, PLLC
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- Cleveland VA Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- Oklahoma City VAMC
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, Forenede Stater, 19004
- MidLantic Urology
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Rhode Island
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Warwick, Rhode Island, Forenede Stater, 02886
- Omega Medical Research
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29403
- Medical University of South Carolina
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Charleston, South Carolina, Forenede Stater, 29401
- Ralph H. Johnson Veterans Affairs Medical Center
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Greenville, South Carolina, Forenede Stater, 29605
- Greenville Health
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Myrtle Beach, South Carolina, Forenede Stater, 29572
- Carolina Urologic Research Center
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Forenede Stater, 75216
- VA North Texas Health Care System
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Houston, Texas, Forenede Stater, 77030
- MD Anderson Cancer Center
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Virginia
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Richmond, Virginia, Forenede Stater, 23235
- Virginia Urology
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Virginia Beach, Virginia, Forenede Stater, 23462
- Urology of Virginia, PLCC
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West Virginia
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Charleston, West Virginia, Forenede Stater, 25304
- CAMC Memorial Hospital, Charleston Area Medical Center Physicians
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Angers, Frankrig, 49933
- CHU d'Angers
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Besançon, Frankrig, 25030
- CHRU Besancon Hopital Jean Minjoz
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Bordeaux, Frankrig, 33076
- Hopital Pellegrin CHU Bordeaux
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Créteil, Frankrig, 94010
- APHP - Hopital Henri Mondor
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Lyon, Frankrig, 69437
- Hopital Edouard Herriot - CHU Lyon
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Nantes, Frankrig, 44000
- CHU de Nantes hotel Dieu
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Paris, Frankrig, 75014
- Institut Mutualiste Montsouris
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Quint-Fonsegrives, Frankrig, 31130
- Clinique de la Croix du Sud
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Rennes, Frankrig, 35033
- Chu Rennes Hopital Pontchaillou
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Toulouse, Frankrig, 31059
- CHU de Toulouse - Hôpital Rangueil
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Tours, Frankrig, 37000
- CHRU Tours Hopital Bretonneau
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Amsterdam, Holland, 1066 CX
- Antoni van Leeuwenhoek
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Eindhoven, Holland, 5623 EJ
- Catharinaziekenhuis
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Nieuwegein, Holland, 3430EM
- St. Antonius Ziekenhuis (St. Antonius Hospital)
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Nijmegen, Holland, 6524 KD
- Canisius-Wilhelmina Ziekenhuis
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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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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, Rusland, 656049
- Altai Regional Oncology Dispensary
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Chelyabinsk, Rusland, 454087
- Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
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Moscow, Rusland, 125284
- Hertzen Oncology Research Institute
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Moscow, Rusland, 121205
- Moscow City Oncology Hospital No 62
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Omsk, Rusland, 644013
- Clinical Oncology Dispensary
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Tyumen, Rusland, 625000
- Medical-sanitary unit 'Neftyanik'
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Vologda, Rusland, 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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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, Tjekkiet, 500 05
- Fakultni nemocnice Hradec Kralove
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Liberec, Tjekkiet, 460 63
- Krajská nemocnice Liberec
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Olomouc, Tjekkiet, 77200
- Uromedical Center s.r.o.
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Pilsen, Tjekkiet, 305 99
- Fakultni nemocnice Plzen, Urologicka klinika
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Prague, Tjekkiet, 140 59
- Thomayerova nemocnice
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Prague, Tjekkiet, 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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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: 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 navne:
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]). |
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
11. juni 2019
Primær færdiggørelse (Anslået)
Primær færdiggørelse
1. december 2026
Studieafslutning (Anslået)
Studieafslutning
13. oktober 2028
Datoer for studieregistrering
Først indsendt
Først indsendt
5. december 2018
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
5. december 2018
Først opslået (Faktiske)
Først opslået
6. december 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
3. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2026
Sidst verificeret
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Genitale neoplasmer, mandlige
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Kønssygdomme, mandlige
- Prostatasygdomme
- Mandlige urogenitale sygdomme
- Prostatiske neoplasmer
- Lægemidlers fysiologiske virkninger
- Hormoner, hormonsubstitutter og hormonantagonister
- Hormonantagonister
- Farmakologiske handlinger
- Kemiske handlinger og anvendelser
- Androgenantagonister
- Apalutamid
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- CR108535
- 2018 (U.S. NIH-bevilling/kontrakt)
- 56021927PCR3011 (Anden identifikator: Janssen Research & Development, LLC)
- 2018-001746-34 (EudraCT nummer)
- 2023-506153-38-00 (Registry Identifier: EUCT number)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .