Uno studio sull'apalutamide nei partecipanti con carcinoma prostatico ad alto rischio, localizzato o localmente avanzato che sono candidati alla prostatectomia radicale (PROTEUS)
2 novembre 2026 aggiornato da: Janssen Research & Development, LLC
Uno studio di fase 3 randomizzato, in doppio cieco, controllato con placebo sull'apalutamide in soggetti con carcinoma prostatico ad alto rischio, localizzato o localmente avanzato candidati alla prostatectomia radicale
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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
2517
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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, Brasile, 74605-070
- Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
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Ijuí, Brasile, 98700-000
- Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
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Natal, Brasile, 59075-740
- Liga Norte Riograndense Contra O Cancer
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Porto Alegre, Brasile, 90020-090
- Irmandade Santa Casa de Misericordia de Porto Alegre
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Rio de Janeiro, Brasile, 20551-030
- Universidade do Estado do Rio de Janeiro - UERJ
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São Paulo, Brasile, 01246 000
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
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São Paulo, Brasile, 01243 020
- Hospital Samaritano de Sao Paulo
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Três Lagoas, Brasile, 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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Hradec Králove, Cechia, 500 05
- Fakultni nemocnice Hradec Kralove
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Liberec, Cechia, 460 63
- Krajská nemocnice Liberec
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Olomouc, Cechia, 77200
- Uromedical Center s.r.o.
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Pilsen, Cechia, 305 99
- Fakultni nemocnice Plzen, Urologicka klinika
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Prague, Cechia, 140 59
- Thomayerova nemocnice
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Prague, Cechia, 120 00
- Vseobecna fakultni nemocnice v Praze
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Gwangju, Corea del Sud, 61469
- Chonnam National University Hospital
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Gyeonggi-do, Corea del Sud, 13605
- Seoul National University Bundang Hospital
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Seoul, Corea del Sud, 05505
- Asan Medical Center
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Seoul, Corea del Sud, 03722
- Severance Hospital Yonsei University Health System
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Seoul, Corea del Sud, 06591
- The Catholic University of Korea Seoul St Marys Hospital
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Seoul, Corea del Sud, 05505
- Asan Medical Center 1
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Angers, Francia, 49933
- CHU d'Angers
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Besançon, Francia, 25030
- CHRU Besancon Hopital Jean Minjoz
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Bordeaux, Francia, 33076
- Hopital Pellegrin CHU Bordeaux
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Créteil, Francia, 94010
- APHP - Hopital Henri Mondor
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Lyon, Francia, 69437
- Hopital Edouard Herriot - CHU Lyon
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Nantes, Francia, 44000
- CHU de Nantes hotel Dieu
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Paris, Francia, 75014
- Institut Mutualiste Montsouris
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Quint-Fonsegrives, Francia, 31130
- Clinique de la Croix du Sud
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Rennes, Francia, 35033
- Chu Rennes Hopital Pontchaillou
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Toulouse, Francia, 31059
- CHU de Toulouse - Hôpital Rangueil
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Tours, Francia, 37000
- CHRU Tours Hopital Bretonneau
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Aachen, Germania, 52074
- Universitaetsklinikum der RWTH Aachen
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Braunschweig, Germania, 38126
- Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie
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Cologne, Germania, 50937
- Universitaetsklinikum Koelnt
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Eisleben Lutherstadt, Germania, 06295
- Praxis Dr. med. Ralf Eckert
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Essen, Germania, 45147
- Universitatsklinikum Essen
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Frankfurt am Main, Germania, 60590
- Universitatsklinikum Frankfurt
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Gronau, Germania, 48599
- Prostata zentrum Nordwest
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Hamburg, Germania, 20246
- Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie
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Homburg/Saar, Germania, 66421
- Universitätsklinikum des Saarlandes
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Lübeck, Germania, 23538
- Universitatsklinikum Schleswig Holstein Campus Lubeck
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Straubing, Germania, 94315
- Klinikum St. Elisabeth Straubing GmbH
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Weiden/Opf, Germania, 92637
- Kliniken Nordoberpfalz, Klinik für Urologie
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Wilhelmshaven, Germania, 26389
- Praxisgemeinschaft f. Onkologie u. Urologie - Germany
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Akita, Giappone, 010-8543
- Akita University Hospital
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Chiba, Giappone, 260 8677
- Chiba University Hospital
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Chūōku, Giappone, 260-8717
- Chiba Cancer Center
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Hakodate, Giappone, 040 8611
- Hakodate Goryoukaku Hospital
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Hirosaki, Giappone, 036-8203
- Hirosaki University Hospital
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Kanazawa, Giappone, 920 8641
- Kanazawa University Hospital
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Kobe, Giappone, 650-0047
- Kobe City Medical Center General Hospital
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Koshigaya, Giappone, 343-8555
- Dokkyo Medical University Saitama Medical Center
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Kurume, Giappone, 830-0011
- Kurume University Hospital
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Kyoto, Giappone, 606-8507
- Kyoto University Hospital
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Matsuyama, Giappone, 791-0280
- National Hospital Organization Shikoku Cancer Center
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Minamiku, Giappone, 252-0375
- Kitasato University Hospital
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Miyazaki, Giappone, 889-1692
- University of Miyazaki Hospital
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Nagano, Giappone, 381-8551
- Nagano Municipal Hospital
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Osaka, Giappone, 541 8567
- Osaka International Cancer Institute
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Sakai, Giappone, 590 0197
- Kindai University Hospital
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Sakura, Giappone, 285-8741
- Toho University Sakura Medical Center
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Sapporo, Giappone, 060-8648
- Hokkaido University Hospital
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Shiwa-gun, Giappone, 028-3695
- Iwate Medical University Hospital
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Tokyo, Giappone, 113-8421
- Juntendo University Hospital
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Tokyo, Giappone, 113 8603
- Nippon Medical School Hospital
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Ube, Giappone, 755-8505
- Yamaguchi University Hospital
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Yokohama, Giappone, 232 0024
- Yokohama City University Medical Center
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Beer Yaakov, Israele, 60930
- Asaf Harofe Medical Center
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Haifa, Israele, 31096
- Rambam Health Care Campus
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Kfar Saba, Israele, 4428164
- Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC)
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Petah Tikva, Israele, 49100
- Rabin Medical Center
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Ramat Gan, Israele, 52621
- The Chaim Sheba Medical Center
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Tel Aviv, Israele, 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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Amsterdam, Olanda, 1066 CX
- Antoni van Leeuwenhoek
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Eindhoven, Olanda, 5623 EJ
- Catharinaziekenhuis
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Nieuwegein, Olanda, 3430EM
- St. Antonius Ziekenhuis (St. Antonius Hospital)
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Nijmegen, Olanda, 6524 KD
- Canisius-Wilhelmina Ziekenhuis
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Bydgoszcz, Polonia, 85 094
- Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
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Bydgoszcz, Polonia, 85 015
- Samodzielny Publiczny Wielospecjalistyczny Zaklad Opieki Zdrowotnej Mswia W Bydgoszczy
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Koszalin, Polonia, 75 581
- Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie
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Krakow, Polonia, 30-727
- Pratia MCM Krakow
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Warsaw, Polonia, 02-473
- City Clinic Sp. z o.o.
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Wroclaw, Polonia, 53-413
- Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - Urologia
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Bristol, Regno Unito, BS10 5NB
- Southmead Hospital
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Cardiff, Regno Unito, CF14 4XW
- University Hospital of Wales
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Dundee, Regno Unito, DD2 1UB
- Ninewells Hospital
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London, Regno Unito, WC1E 6BT
- University College London
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London, Regno Unito, SW3 6JJ
- The Royal Marsden NHS Trust
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Preston, Regno Unito, PR2 9HT
- Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
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Sutton, Regno Unito, SM2 5PT
- Royal Marsden Hospital
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Wakefield, Regno Unito, WF1 4DG
- Mid Yorkshire NHS Trust
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Wolverhampton, Regno Unito, WV10 0QP
- New Cross Hospital
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Barnaul, Russia, 656049
- Altai Regional Oncology Dispensary
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Chelyabinsk, Russia, 454087
- Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
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Moscow, Russia, 125284
- Hertzen Oncology Research Institute
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Moscow, Russia, 121205
- Moscow City Oncology Hospital No 62
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Omsk, Russia, 644013
- Clinical Oncology Dispensary
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Tyumen, Russia, 625000
- Medical-sanitary unit 'Neftyanik'
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Vologda, Russia, 160012
- Vologda Regional Oncological Dispensary
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A Coruña, Spagna, 15006
- Hosp Univ A Coruna
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Barcelona, Spagna, 8035
- Hosp Univ Vall D Hebron
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Cadiz, Spagna, 11009
- Hosp. Puerta Del Mar
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Castellon, Spagna, 12004
- Hosp. Gral. Univ. de Castellon
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Jerez de la Frontera, Spagna, 11407
- Hosp. de Jerez de La Frontera
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Madrid, Spagna, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Spagna, 28034
- Hosp. Univ. Ramon Y Cajal
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Madrid, Spagna, 28046
- Hosp. Univ. La Paz
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Manacor, Spagna, 07500
- Fund. Hosp. de Manacor
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Málaga, Spagna, 29010
- Hosp Virgen de La Victoria
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Santander, Spagna, 39008
- Hosp. Univ. Marques de Valdecilla
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Seville, Spagna, 41013
- Hosp. Virgen Del Rocio
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Valencia, Spagna, 46009
- Inst. Valenciano de Oncologia
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Valencia, Spagna, 46010
- Hosp. Clinico Univ. de Valencia
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California
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La Jolla, California, Stati Uniti, 92093
- UC San Diego Moores Cancer Center
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Los Angeles, California, Stati Uniti, 90033
- University of Southern California
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Los Angeles, California, Stati Uniti, 90095
- University of California Los Angeles
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Los Angeles, California, Stati Uniti, 90048
- Cedars Sinai Medical Center
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Orange, California, Stati Uniti, 92868
- University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
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Sacramento, California, Stati Uniti, 95817
- UC Davis Medical Center
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Colorado
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Denver, Colorado, Stati Uniti, 80210
- AdventHealth Medical Group Urology of Denver
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Lakewood, Colorado, Stati Uniti, 80228
- Colorado Clinical Research
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Connecticut
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Stamford, Connecticut, Stati Uniti, 06904
- Stamford Hospital
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Florida
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Hialeah, Florida, Stati Uniti, 33002
- Urology Specialists LLC
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Jacksonville, Florida, Stati Uniti, 32224
- Mayo Clinic - Division Of Hematology/oncology
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Miami, Florida, Stati Uniti, 33176
- Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
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Orlando, Florida, Stati Uniti, 32804
- Advent Health
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322-1013
- Emory University Winship Cancer Institute
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Illinois
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Chicago, Illinois, Stati Uniti, 60637
- University of Chicago
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Louisiana
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Shreveport, Louisiana, Stati Uniti, 71106
- Ochsner LSU Health Shreveport - Regional Urology
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- Dana Farber Cancer Institute
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Boston, Massachusetts, Stati Uniti, 02215
- Beth Isreal Deaconess Medical Center
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Michigan
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Troy, Michigan, Stati Uniti, 48084
- Michigan Institute of Urology, PC
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Missouri
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St Louis, Missouri, Stati Uniti, 63110
- Saint Louis University
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68130
- Urology Cancer Center, PC
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New York
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Albany, New York, Stati Uniti, 12208
- Albany Medical College
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Cheektowaga, New York, Stati Uniti, 14225
- Great Lakes Physician PC d/b/a Western New York Urology Associates
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New York, New York, Stati Uniti, 10065
- Weill Cornell Medical College
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New York, New York, Stati Uniti, 10065
- Memorial Sloan-Kettering Cancer Center
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Syracuse, New York, Stati Uniti, 13210
- SUNY Upstate Medical University
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27599
- University of North Carolina
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Durham, North Carolina, Stati Uniti, 27705
- Duke University School of Medicine
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Greensboro, North Carolina, Stati Uniti, 27403
- Medication Management LLC
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Huntersville, North Carolina, Stati Uniti, 28078
- Carolina Urology Partners, PLLC
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Ohio
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Cleveland, Ohio, Stati Uniti, 44106
- Cleveland VA Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- Oklahoma City VAMC
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, Stati Uniti, 19004
- MidLantic Urology
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Rhode Island
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Warwick, Rhode Island, Stati Uniti, 02886
- Omega Medical Research
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29403
- Medical University of South Carolina
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Charleston, South Carolina, Stati Uniti, 29401
- Ralph H. Johnson Veterans Affairs Medical Center
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Greenville, South Carolina, Stati Uniti, 29605
- Greenville Health
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Myrtle Beach, South Carolina, Stati Uniti, 29572
- Carolina Urologic Research Center
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, Stati Uniti, 75216
- VA North Texas Health Care System
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Houston, Texas, Stati Uniti, 77030
- MD Anderson Cancer Center
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Virginia
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Richmond, Virginia, Stati Uniti, 23235
- Virginia Urology
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Virginia Beach, Virginia, Stati Uniti, 23462
- Urology of Virginia, PLCC
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West Virginia
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Charleston, West Virginia, Stati Uniti, 25304
- CAMC Memorial Hospital, Charleston Area Medical Center Physicians
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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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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Maschio
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
Altri nomi:
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]). |
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants with Pathologic complete response (pCR)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Prostate Specific Antigen (PSA)-Free Survival
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
11 giugno 2019
Completamento primario (Stimato)
1 dicembre 2026
Completamento dello studio (Stimato)
13 ottobre 2028
Date di iscrizione allo studio
Primo inviato
5 dicembre 2018
Primo inviato che soddisfa i criteri di controllo qualità
5 dicembre 2018
Primo Inserito (Effettivo)
6 dicembre 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 novembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 novembre 2026
Ultimo verificato
1 novembre 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Neoplasie genitali, maschio
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie
- Malattie genitali, maschio
- Malattie della prostata
- Malattie urogenitali maschili
- Neoplasie prostatiche
- Effetti fisiologici dei farmaci
- Ormoni, sostituti ormonali e antagonisti ormonali
- Antagonisti ormonali
- Azioni farmacologiche
- Azioni e usi chimici
- Antagonisti degli androgeni
- apalutamide
Altri numeri di identificazione dello studio
- CR108535
- 2018 (Sovvenzione/contratto NIH degli Stati Uniti)
- 56021927PCR3011 (Altro identificatore: Janssen Research & Development, LLC)
- 2018-001746-34 (Numero EudraCT)
- 2023-506153-38-00 (Identificatore di registro: EUCT number)
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .