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Apalutamide 在作为根治性前列腺切除术候选人的高风险、局限性或局部晚期前列腺癌参与者中的研究 (PROTEUS)

2026年11月2日更新者：Janssen Research & Development, LLC

一项随机、双盲、安慰剂对照的 3 期阿帕鲁胺在高危、局限性或局部晚期前列腺癌患者中的研究，这些患者是根治性前列腺切除术的候选者

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.

研究概览

地位

主动，不招人

条件

前列腺肿瘤

干预/治疗

研究类型

介入性

注册 (实际的)

2517

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：四人间

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：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.	药品：Apalutamide Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily. 其他名称： JNJ-56021927 药品：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]).
实验性的：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.	药品：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]). 药品：Placebo Participants will receive matching placebo oral tablets daily.

参与者组/臂

干预/治疗

实验性的：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.

药品：Apalutamide

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

其他名称：

JNJ-56021927

药品：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]).

实验性的：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.

药品：Androgen Deprivation Therapy (ADT)

药品：Placebo

Participants will receive matching placebo oral tablets daily.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Percentage of Participants with Pathologic complete response (pCR) 大体时间：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) 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
Prostate Specific Antigen (PSA)-Free Survival 大体时间：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) 大体时间：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) 大体时间：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) 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Janssen Research & Development, LLC

调查人员

研究主任：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

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一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年6月11日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2028年10月13日

研究注册日期

首次提交

2018年12月5日

首先提交符合 QC 标准的

2018年12月5日

首次发布 (实际的)

2018年12月6日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

Apalutamide 在作为根治性前列腺切除术候选人的高风险、局限性或局部晚期前列腺癌参与者中的研究 (PROTEUS)

一项随机、双盲、安慰剂对照的 3 期阿帕鲁胺在高危、局限性或局部晚期前列腺癌患者中的研究，这些患者是根治性前列腺切除术的候选者

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

有资格学习的性别

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

出版物和有用的链接

一般刊物

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (估计的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

IPD 计划说明

药物和器械信息、研究文件

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