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Un estudio de apalutamida en participantes con cáncer de próstata de alto riesgo, localizado o localmente avanzado que son candidatos para la prostatectomía radical (PROTEUS)

2 de noviembre de 2026 actualizado por: Janssen Research & Development, LLC

Un estudio de fase 3, aleatorizado, doble ciego, controlado con placebo de apalutamida en sujetos con cáncer de próstata de alto riesgo, localizado o localmente avanzado que son candidatos para la prostatectomía radical

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.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

2517

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Aachen, Alemania, 52074
        • Universitaetsklinikum der RWTH Aachen
      • Braunschweig, Alemania, 38126
        • Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie
      • Cologne, Alemania, 50937
        • Universitaetsklinikum Koelnt
      • Eisleben Lutherstadt, Alemania, 06295
        • Praxis Dr. med. Ralf Eckert
      • Essen, Alemania, 45147
        • Universitatsklinikum Essen
      • Frankfurt am Main, Alemania, 60590
        • Universitatsklinikum Frankfurt
      • Gronau, Alemania, 48599
        • Prostata zentrum Nordwest
      • Hamburg, Alemania, 20246
        • Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie
      • Homburg/Saar, Alemania, 66421
        • Universitätsklinikum des Saarlandes
      • Lübeck, Alemania, 23538
        • Universitatsklinikum Schleswig Holstein Campus Lubeck
      • Straubing, Alemania, 94315
        • Klinikum St. Elisabeth Straubing GmbH
      • Weiden/Opf, Alemania, 92637
        • Kliniken Nordoberpfalz, Klinik für Urologie
      • Wilhelmshaven, Alemania, 26389
        • Praxisgemeinschaft f. Onkologie u. Urologie - Germany
  • Argentina
      • Caba, Argentina, 1118
        • Hospital Aleman
      • Ciudad Autonoma de, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires
      • Córdoba, Argentina, X5000KPH
        • Centro Urologico Profesor Bengio
      • Córdoba, Argentina, X5008AAC
        • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
      • Mendoza, Argentina, 5500
        • Uroclinica
      • San Miguel de Tucumán, Argentina, 4000
        • Clinica Mayo de UMCB
  • Australia
      • Box Hill, Australia, 3128q
        • Eastern Health - Box Hill Hospital
      • Darlinghurst, Australia, 2010
        • St Vincent s Hospital Sydney
      • Heidelberg, Australia, 3084
        • Austin Health
      • Malvern, Australia, 3144
        • Australian Urology Associates Pty Ltd
      • Parkville, Australia, 3052
        • Royal Melbourne Hospital
      • St Leonards, Australia, 2065
        • Northern Cancer Institute
      • Wahroonga, Australia, 2076
        • Sydney Adventist Hospital
      • Westmead, Australia, 2145
        • Westmead Hospital
      • Woolloongabba, Australia, 4102
        • Princess Alexandra Hospital
  • Brasil
      • Goiânia, Brasil, 74605-070
        • Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
      • Ijuí, Brasil, 98700-000
        • Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
      • Natal, Brasil, 59075-740
        • Liga Norte Riograndense Contra O Cancer
      • Porto Alegre, Brasil, 90020-090
        • Irmandade Santa Casa de Misericordia de Porto Alegre
      • Rio de Janeiro, Brasil, 20551-030
        • Universidade do Estado do Rio de Janeiro - UERJ
      • São Paulo, Brasil, 01246 000
        • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
      • São Paulo, Brasil, 01243 020
        • Hospital Samaritano de Sao Paulo
      • Três Lagoas, Brasil, 79601-001
        • Instituto Do Cancer Brasil
  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2V 1P9
        • Prostate Cancer Centre
    • British Columbia
      • Vancouver, British Columbia, Canadá, V5Z 1M9
        • Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canadá, B3H 2Y9
        • Nova Scotia Health Authority
    • Ontario
      • London, Ontario, Canadá, N6A 5W9
        • London Health Sciences Center
      • Toronto, Ontario, Canadá, M5G2M9
        • Princess Margaret Cancer Centre University Health Network
      • Toronto, Ontario, Canadá, M4N 3M5
        • Sunnybrook Health Sciences Center
    • Quebec
      • Montreal, Quebec, Canadá, H2X 0A9
        • CHUM - Centre hospitalier universitaire de Montreal
      • Québec, Quebec, Canadá, G1R 2J6
        • CHU de Quebec Universite Laval Hopital de l Enfant Jesus
  • Chequia
      • Hradec Králove, Chequia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Liberec, Chequia, 460 63
        • Krajská nemocnice Liberec
      • Olomouc, Chequia, 77200
        • Uromedical Center s.r.o.
      • Pilsen, Chequia, 305 99
        • Fakultni nemocnice Plzen, Urologicka klinika
      • Prague, Chequia, 140 59
        • Thomayerova nemocnice
      • Prague, Chequia, 120 00
        • Vseobecna fakultni nemocnice v Praze
  • Corea del Sur
      • Gwangju, Corea del Sur, 61469
        • Chonnam National University Hospital
      • Gyeonggi-do, Corea del Sur, 13605
        • Seoul National University Bundang Hospital
      • Seoul, Corea del Sur, 05505
        • Asan Medical Center
      • Seoul, Corea del Sur, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Corea del Sur, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
      • Seoul, Corea del Sur, 05505
        • Asan Medical Center 1
  • España
      • A Coruña, España, 15006
        • Hosp Univ A Coruna
      • Barcelona, España, 8035
        • Hosp Univ Vall D Hebron
      • Cadiz, España, 11009
        • Hosp. Puerta Del Mar
      • Castellon, España, 12004
        • Hosp. Gral. Univ. de Castellon
      • Jerez de la Frontera, España, 11407
        • Hosp. de Jerez de La Frontera
      • Madrid, España, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, España, 28034
        • Hosp. Univ. Ramon Y Cajal
      • Madrid, España, 28046
        • Hosp. Univ. La Paz
      • Manacor, España, 07500
        • Fund. Hosp. de Manacor
      • Málaga, España, 29010
        • Hosp Virgen de La Victoria
      • Santander, España, 39008
        • Hosp. Univ. Marques de Valdecilla
      • Seville, España, 41013
        • Hosp. Virgen Del Rocio
      • Valencia, España, 46009
        • Inst. Valenciano de Oncologia
      • Valencia, España, 46010
        • Hosp. Clinico Univ. de Valencia
  • Estados Unidos
    • California
      • La Jolla, California, Estados Unidos, 92093
        • UC San Diego Moores Cancer Center
      • Los Angeles, California, Estados Unidos, 90033
        • University of Southern California
      • Los Angeles, California, Estados Unidos, 90095
        • University of California Los Angeles
      • Los Angeles, California, Estados Unidos, 90048
        • Cedars Sinai Medical Center
      • Orange, California, Estados Unidos, 92868
        • University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
      • Sacramento, California, Estados Unidos, 95817
        • UC Davis Medical Center
    • Colorado
      • Denver, Colorado, Estados Unidos, 80210
        • AdventHealth Medical Group Urology of Denver
      • Lakewood, Colorado, Estados Unidos, 80228
        • Colorado Clinical Research
    • Connecticut
      • Stamford, Connecticut, Estados Unidos, 06904
        • Stamford Hospital
    • Florida
      • Hialeah, Florida, Estados Unidos, 33002
        • Urology Specialists LLC
      • Jacksonville, Florida, Estados Unidos, 32224
        • Mayo Clinic - Division Of Hematology/oncology
      • Miami, Florida, Estados Unidos, 33176
        • Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
      • Orlando, Florida, Estados Unidos, 32804
        • Advent Health
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322-1013
        • Emory University Winship Cancer Institute
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
        • University of Chicago
    • Louisiana
      • Shreveport, Louisiana, Estados Unidos, 71106
        • Ochsner LSU Health Shreveport - Regional Urology
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, Estados Unidos, 02215
        • Beth Isreal Deaconess Medical Center
    • Michigan
      • Troy, Michigan, Estados Unidos, 48084
        • Michigan Institute of Urology, PC
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63110
        • Saint Louis University
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68130
        • Urology Cancer Center, PC
    • New York
      • Albany, New York, Estados Unidos, 12208
        • Albany Medical College
      • Cheektowaga, New York, Estados Unidos, 14225
        • Great Lakes Physician PC d/b/a Western New York Urology Associates
      • New York, New York, Estados Unidos, 10065
        • Weill Cornell Medical College
      • New York, New York, Estados Unidos, 10065
        • Memorial Sloan-Kettering Cancer Center
      • Syracuse, New York, Estados Unidos, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • University of North Carolina
      • Durham, North Carolina, Estados Unidos, 27705
        • Duke University School of Medicine
      • Greensboro, North Carolina, Estados Unidos, 27403
        • Medication Management LLC
      • Huntersville, North Carolina, Estados Unidos, 28078
        • Carolina Urology Partners, PLLC
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44106
        • Cleveland VA Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Oklahoma City VAMC
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, Estados Unidos, 19004
        • MidLantic Urology
    • Rhode Island
      • Warwick, Rhode Island, Estados Unidos, 02886
        • Omega Medical Research
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29403
        • Medical University of South Carolina
      • Charleston, South Carolina, Estados Unidos, 29401
        • Ralph H. Johnson Veterans Affairs Medical Center
      • Greenville, South Carolina, Estados Unidos, 29605
        • Greenville Health
      • Myrtle Beach, South Carolina, Estados Unidos, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, Estados Unidos, 75216
        • VA North Texas Health Care System
      • Houston, Texas, Estados Unidos, 77030
        • MD Anderson Cancer Center
    • Virginia
      • Richmond, Virginia, Estados Unidos, 23235
        • Virginia Urology
      • Virginia Beach, Virginia, Estados Unidos, 23462
        • Urology of Virginia, PLCC
    • West Virginia
      • Charleston, West Virginia, Estados Unidos, 25304
        • CAMC Memorial Hospital, Charleston Area Medical Center Physicians
  • Francia
      • Angers, Francia, 49933
        • CHU d'Angers
      • Besançon, Francia, 25030
        • CHRU Besancon Hopital Jean Minjoz
      • Bordeaux, Francia, 33076
        • Hopital Pellegrin CHU Bordeaux
      • Créteil, Francia, 94010
        • APHP - Hopital Henri Mondor
      • Lyon, Francia, 69437
        • Hopital Edouard Herriot - CHU Lyon
      • Nantes, Francia, 44000
        • CHU de Nantes hotel Dieu
      • Paris, Francia, 75014
        • Institut Mutualiste Montsouris
      • Quint-Fonsegrives, Francia, 31130
        • Clinique de la Croix du Sud
      • Rennes, Francia, 35033
        • Chu Rennes Hopital Pontchaillou
      • Toulouse, Francia, 31059
        • CHU de Toulouse - Hôpital Rangueil
      • Tours, Francia, 37000
        • CHRU Tours Hopital Bretonneau
  • Israel
      • Beer Yaakov, Israel, 60930
        • Asaf Harofe Medical Center
      • Haifa, Israel, 31096
        • Rambam Health Care Campus
      • Kfar Saba, Israel, 4428164
        • Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC)
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center
      • Ramat Gan, Israel, 52621
        • The Chaim Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • Italia
      • Abano Terme, Italia, 35031
        • Policlinico Abano Terme
      • Acquaviva delle Fonti, Italia, 70021
        • Generale Regionale F. Miulli
      • Bassano del Grappa, Italia, 36061
        • Ospedale di Bassano del Grappa
      • Brescia, Italia, 25123
        • ASST Spedali Civili Brescia
      • Chieti, Italia, 66100
        • ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti
      • Florence, Italia, 50134
        • Azienda Ospedaliero Universitaria Careggi
      • Milan, Italia, 20132
        • Ospedale San Raffaele
      • Milan, Italia, 20141
        • Istituto Europeo di Oncologia
      • Milan, Italia, 20127
        • San Raffaele Turro - Istituto di Ricovero e Cura a Carattere Scientifico
      • Modena, Italia, 41100
        • Clinica di Urologia Policlinico di Modena - Universita di Modena e reggio Emilia
      • Novara, Italia, 28100
        • Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara
      • Orbassano, Italia, 10043
        • Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga
      • Roma, Italia, 00144
        • Istituto Nazionale Tumori Regina Elena
      • Roma, Italia, 00189
        • Azienda Ospedaliera Sant Andrea
      • Roma, Italia, 00128
        • Universita Campus Bio-Medico di Roma
      • Torino, Italia, 10126
        • Ospedale Molinette, AO Città della Salute e della Scienza di
      • Verona, Italia, 37126
        • UOC di Urologia AOU Integrata di Verona - Polo Chirurgico Confortini - Ospedale Borgo Trento
  • Japón
      • Akita, Japón, 010-8543
        • Akita University Hospital
      • Chiba, Japón, 260 8677
        • Chiba University Hospital
      • Chūōku, Japón, 260-8717
        • Chiba Cancer Center
      • Hakodate, Japón, 040 8611
        • Hakodate Goryoukaku Hospital
      • Hirosaki, Japón, 036-8203
        • Hirosaki University Hospital
      • Kanazawa, Japón, 920 8641
        • Kanazawa University Hospital
      • Kobe, Japón, 650-0047
        • Kobe City Medical Center General Hospital
      • Koshigaya, Japón, 343-8555
        • Dokkyo Medical University Saitama Medical Center
      • Kurume, Japón, 830-0011
        • Kurume University Hospital
      • Kyoto, Japón, 606-8507
        • Kyoto University Hospital
      • Matsuyama, Japón, 791-0280
        • National Hospital Organization Shikoku Cancer Center
      • Minamiku, Japón, 252-0375
        • Kitasato University Hospital
      • Miyazaki, Japón, 889-1692
        • University of Miyazaki Hospital
      • Nagano, Japón, 381-8551
        • Nagano Municipal Hospital
      • Osaka, Japón, 541 8567
        • Osaka International Cancer Institute
      • Sakai, Japón, 590 0197
        • Kindai University Hospital
      • Sakura, Japón, 285-8741
        • Toho University Sakura Medical Center
      • Sapporo, Japón, 060-8648
        • Hokkaido University Hospital
      • Shiwa-gun, Japón, 028-3695
        • Iwate Medical University Hospital
      • Tokyo, Japón, 113-8421
        • Juntendo University Hospital
      • Tokyo, Japón, 113 8603
        • Nippon Medical School Hospital
      • Ube, Japón, 755-8505
        • Yamaguchi University Hospital
      • Yokohama, Japón, 232 0024
        • Yokohama City University Medical Center
  • Países Bajos
      • Amsterdam, Países Bajos, 1066 CX
        • Antoni van Leeuwenhoek
      • Eindhoven, Países Bajos, 5623 EJ
        • Catharinaziekenhuis
      • Nieuwegein, Países Bajos, 3430EM
        • St. Antonius Ziekenhuis (St. Antonius Hospital)
      • Nijmegen, Países Bajos, 6524 KD
        • Canisius-Wilhelmina Ziekenhuis
  • Polonia
      • Bydgoszcz, Polonia, 85 094
        • Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
      • Bydgoszcz, Polonia, 85 015
        • Samodzielny Publiczny Wielospecjalistyczny Zaklad Opieki Zdrowotnej Mswia W Bydgoszczy
      • Koszalin, Polonia, 75 581
        • Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie
      • Krakow, Polonia, 30-727
        • Pratia MCM Krakow
      • Warsaw, Polonia, 02-473
        • City Clinic Sp. z o.o.
      • Wroclaw, Polonia, 53-413
        • Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - Urologia
  • Reino Unido
      • Bristol, Reino Unido, BS10 5NB
        • Southmead Hospital
      • Cardiff, Reino Unido, CF14 4XW
        • University Hospital of Wales
      • Dundee, Reino Unido, DD2 1UB
        • Ninewells Hospital
      • London, Reino Unido, WC1E 6BT
        • University College London
      • London, Reino Unido, SW3 6JJ
        • The Royal Marsden NHS Trust
      • Preston, Reino Unido, PR2 9HT
        • Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
      • Sutton, Reino Unido, SM2 5PT
        • Royal Marsden Hospital
      • Wakefield, Reino Unido, WF1 4DG
        • Mid Yorkshire NHS Trust
      • Wolverhampton, Reino Unido, WV10 0QP
        • New Cross Hospital
  • Rusia
      • Barnaul, Rusia, 656049
        • Altai Regional Oncology Dispensary
      • Chelyabinsk, Rusia, 454087
        • Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
      • Moscow, Rusia, 125284
        • Hertzen Oncology Research Institute
      • Moscow, Rusia, 121205
        • Moscow City Oncology Hospital No 62
      • Omsk, Rusia, 644013
        • Clinical Oncology Dispensary
      • Tyumen, Rusia, 625000
        • Medical-sanitary unit 'Neftyanik'
      • Vologda, Rusia, 160012
        • Vologda Regional Oncological Dispensary
  • Taiwán
      • Kaohsiung City, Taiwán, 807
        • Kaohsiung Medical University Chung Ho Memorial Hospital
      • Taichung, Taiwán, 40447
        • China Medical University Hospital
      • Taichung, Taiwán, 40705
        • Taichung Veterans General Hospital
      • Taichung, Taiwán, 435
        • Tungs' Taichung MetroHarbor Hospital
      • Tainan, Taiwán, 710
        • Chi Mei Medical Center Yong Kang
      • Taipei, Taiwán, 10002
        • National Taiwan University Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Masculino

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: Apalutamide

Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.

Otros nombres:
  • JNJ-56021927
Droga: Androgen Deprivation Therapy (ADT)

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]).
Experimental: 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.
Droga: Androgen Deprivation Therapy (ADT)

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]).

Droga: Placebo

Participants will receive matching placebo oral tablets daily.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants with Pathologic complete response (pCR)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Prostate Specific Antigen (PSA)-Free Survival
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Janssen Research & Development, LLC

Investigadores

  • Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de junio de 2019

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

13 de octubre de 2028

Fechas de registro del estudio

Enviado por primera vez

5 de diciembre de 2018

Primero enviado que cumplió con los criterios de control de calidad

5 de diciembre de 2018

Publicado por primera vez (Actual)

6 de diciembre de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CR108535
  • 2018 (Subvención/contrato del NIH de EE. UU.)
  • 56021927PCR3011 (Otro identificador: Janssen Research & Development, LLC)
  • 2018-001746-34 (Número EudraCT)
  • 2023-506153-38-00 (Identificador de registro: EUCT number)
  • 2023 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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