근치적 전립선 절제술의 대상자인 고위험, 국소 또는 국소 진행성 전립선암 환자의 아팔루타마이드에 대한 연구 (PROTEUS)
2026년 11월 2일 업데이트: Janssen Research & Development, LLC
근치적 전립선 절제술을 받을 수 있는 고위험, 국소 또는 국소 진행성 전립선암 대상자를 대상으로 한 무작위, 이중 맹검, 위약 대조, 3상 아팔루타마이드 연구
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.
연구 개요
상태
상태
모집하지 않고 적극적으로
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (실제)
등록
2517
단계
단계
- 3단계
연락처 및 위치
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연구 장소
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Amsterdam, 네덜란드, 1066 CX
- Antoni van Leeuwenhoek
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Eindhoven, 네덜란드, 5623 EJ
- Catharinaziekenhuis
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Nieuwegein, 네덜란드, 3430EM
- St. Antonius Ziekenhuis (St. Antonius Hospital)
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Nijmegen, 네덜란드, 6524 KD
- Canisius-Wilhelmina Ziekenhuis
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Kaohsiung City, 대만, 807
- Kaohsiung Medical University Chung Ho Memorial Hospital
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Taichung, 대만, 40447
- China Medical University Hospital
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Taichung, 대만, 40705
- Taichung Veterans General Hospital
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Taichung, 대만, 435
- Tungs' Taichung MetroHarbor Hospital
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Tainan, 대만, 710
- Chi Mei Medical Center Yong Kang
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Taipei, 대만, 10002
- National Taiwan University Hospital
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Gwangju, 대한민국, 61469
- Chonnam National University Hospital
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Gyeonggi-do, 대한민국, 13605
- Seoul National University Bundang Hospital
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Seoul, 대한민국, 05505
- Asan Medical Center
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Seoul, 대한민국, 03722
- Severance Hospital Yonsei University Health System
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Seoul, 대한민국, 06591
- The Catholic University of Korea Seoul St Marys Hospital
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Seoul, 대한민국, 05505
- Asan Medical Center 1
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Aachen, 독일, 52074
- Universitaetsklinikum der RWTH Aachen
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Braunschweig, 독일, 38126
- Stadtisches Klinikum Braunschweig gGmbH-Klinik fur Urologie und Uroonkologie
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Cologne, 독일, 50937
- Universitaetsklinikum Koelnt
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Eisleben Lutherstadt, 독일, 06295
- Praxis Dr. med. Ralf Eckert
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Essen, 독일, 45147
- Universitatsklinikum Essen
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Frankfurt am Main, 독일, 60590
- Universitatsklinikum Frankfurt
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Gronau, 독일, 48599
- Prostata zentrum Nordwest
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Hamburg, 독일, 20246
- Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie
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Homburg/Saar, 독일, 66421
- Universitätsklinikum des Saarlandes
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Lübeck, 독일, 23538
- Universitatsklinikum Schleswig Holstein Campus Lubeck
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Straubing, 독일, 94315
- Klinikum St. Elisabeth Straubing GmbH
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Weiden/Opf, 독일, 92637
- Kliniken Nordoberpfalz, Klinik für Urologie
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Wilhelmshaven, 독일, 26389
- Praxisgemeinschaft f. Onkologie u. Urologie - Germany
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Barnaul, 러시아 제국, 656049
- Altai Regional Oncology Dispensary
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Chelyabinsk, 러시아 제국, 454087
- Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine
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Moscow, 러시아 제국, 125284
- Hertzen Oncology Research Institute
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Moscow, 러시아 제국, 121205
- Moscow City Oncology Hospital No 62
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Omsk, 러시아 제국, 644013
- Clinical Oncology Dispensary
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Tyumen, 러시아 제국, 625000
- Medical-sanitary unit 'Neftyanik'
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Vologda, 러시아 제국, 160012
- Vologda Regional Oncological Dispensary
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California
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La Jolla, California, 미국, 92093
- UC San Diego Moores Cancer Center
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Los Angeles, California, 미국, 90033
- University of Southern California
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Los Angeles, California, 미국, 90095
- University of California Los Angeles
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Los Angeles, California, 미국, 90048
- Cedars Sinai Medical Center
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Orange, California, 미국, 92868
- University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
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Sacramento, California, 미국, 95817
- UC Davis Medical Center
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Colorado
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Denver, Colorado, 미국, 80210
- AdventHealth Medical Group Urology of Denver
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Lakewood, Colorado, 미국, 80228
- Colorado Clinical Research
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Connecticut
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Stamford, Connecticut, 미국, 06904
- Stamford Hospital
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Florida
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Hialeah, Florida, 미국, 33002
- Urology Specialists LLC
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Jacksonville, Florida, 미국, 32224
- Mayo Clinic - Division Of Hematology/oncology
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Miami, Florida, 미국, 33176
- Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
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Orlando, Florida, 미국, 32804
- Advent Health
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Georgia
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Atlanta, Georgia, 미국, 30322-1013
- Emory University Winship Cancer Institute
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Illinois
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Chicago, Illinois, 미국, 60637
- University of Chicago
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Louisiana
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Shreveport, Louisiana, 미국, 71106
- Ochsner LSU Health Shreveport - Regional Urology
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Dana Farber Cancer Institute
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Boston, Massachusetts, 미국, 02215
- Beth Isreal Deaconess Medical Center
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Michigan
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Troy, Michigan, 미국, 48084
- Michigan Institute of Urology, PC
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Missouri
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St Louis, Missouri, 미국, 63110
- Saint Louis University
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Nebraska
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Omaha, Nebraska, 미국, 68130
- Urology Cancer Center, PC
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New York
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Albany, New York, 미국, 12208
- Albany Medical College
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Cheektowaga, New York, 미국, 14225
- Great Lakes Physician PC d/b/a Western New York Urology Associates
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New York, New York, 미국, 10065
- Weill Cornell Medical College
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New York, New York, 미국, 10065
- Memorial Sloan-Kettering Cancer Center
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Syracuse, New York, 미국, 13210
- SUNY Upstate Medical University
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- University of North Carolina
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Durham, North Carolina, 미국, 27705
- Duke University School of Medicine
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Greensboro, North Carolina, 미국, 27403
- Medication Management LLC
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Huntersville, North Carolina, 미국, 28078
- Carolina Urology Partners, PLLC
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Ohio
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Cleveland, Ohio, 미국, 44106
- Cleveland VA Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73104
- Oklahoma City VAMC
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, 미국, 19004
- MidLantic Urology
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Rhode Island
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Warwick, Rhode Island, 미국, 02886
- Omega Medical Research
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South Carolina
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Charleston, South Carolina, 미국, 29403
- Medical University of South Carolina
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Charleston, South Carolina, 미국, 29401
- Ralph H. Johnson Veterans Affairs Medical Center
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Greenville, South Carolina, 미국, 29605
- Greenville Health
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Myrtle Beach, South Carolina, 미국, 29572
- Carolina Urologic Research Center
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Tennessee
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Nashville, Tennessee, 미국, 37232
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, 미국, 75216
- VA North Texas Health Care System
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Houston, Texas, 미국, 77030
- MD Anderson Cancer Center
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Virginia
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Richmond, Virginia, 미국, 23235
- Virginia Urology
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Virginia Beach, Virginia, 미국, 23462
- Urology of Virginia, PLCC
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West Virginia
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Charleston, West Virginia, 미국, 25304
- CAMC Memorial Hospital, Charleston Area Medical Center Physicians
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Goiânia, 브라질, 74605-070
- Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge
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Ijuí, 브라질, 98700-000
- Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
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Natal, 브라질, 59075-740
- Liga Norte Riograndense Contra O Cancer
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Porto Alegre, 브라질, 90020-090
- Irmandade Santa Casa de Misericordia de Porto Alegre
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Rio de Janeiro, 브라질, 20551-030
- Universidade do Estado do Rio de Janeiro - UERJ
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São Paulo, 브라질, 01246 000
- Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
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São Paulo, 브라질, 01243 020
- Hospital Samaritano de Sao Paulo
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Três Lagoas, 브라질, 79601-001
- Instituto Do Cancer Brasil
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A Coruña, 스페인, 15006
- Hosp Univ A Coruna
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Barcelona, 스페인, 8035
- Hosp Univ Vall D Hebron
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Cadiz, 스페인, 11009
- Hosp. Puerta Del Mar
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Castellon, 스페인, 12004
- Hosp. Gral. Univ. de Castellon
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Jerez de la Frontera, 스페인, 11407
- Hosp. de Jerez de La Frontera
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Madrid, 스페인, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, 스페인, 28034
- Hosp. Univ. Ramon Y Cajal
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Madrid, 스페인, 28046
- Hosp. Univ. La Paz
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Manacor, 스페인, 07500
- Fund. Hosp. de Manacor
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Málaga, 스페인, 29010
- Hosp Virgen de La Victoria
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Santander, 스페인, 39008
- Hosp. Univ. Marques de Valdecilla
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Seville, 스페인, 41013
- Hosp. Virgen Del Rocio
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Valencia, 스페인, 46009
- Inst. Valenciano de Oncologia
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Valencia, 스페인, 46010
- Hosp. Clinico Univ. de Valencia
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Caba, 아르헨티나, 1118
- Hospital Aleman
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Ciudad Autonoma de, 아르헨티나, C1199ABB
- Hospital Italiano de Buenos Aires
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Córdoba, 아르헨티나, X5000KPH
- Centro Urologico Profesor Bengio
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Córdoba, 아르헨티나, X5008AAC
- Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
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Mendoza, 아르헨티나, 5500
- Uroclinica
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San Miguel de Tucumán, 아르헨티나, 4000
- Clinica Mayo de UMCB
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Bristol, 영국, BS10 5NB
- Southmead Hospital
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Cardiff, 영국, CF14 4XW
- University Hospital of Wales
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Dundee, 영국, DD2 1UB
- Ninewells Hospital
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London, 영국, WC1E 6BT
- University College London
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London, 영국, SW3 6JJ
- The Royal Marsden NHS Trust
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Preston, 영국, PR2 9HT
- Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital
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Sutton, 영국, SM2 5PT
- Royal Marsden Hospital
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Wakefield, 영국, WF1 4DG
- Mid Yorkshire NHS Trust
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Wolverhampton, 영국, WV10 0QP
- New Cross Hospital
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Beer Yaakov, 이스라엘, 60930
- Asaf Harofe Medical Center
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Haifa, 이스라엘, 31096
- Rambam Health Care Campus
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Kfar Saba, 이스라엘, 4428164
- Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC)
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Petah Tikva, 이스라엘, 49100
- Rabin Medical Center
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Ramat Gan, 이스라엘, 52621
- The Chaim Sheba Medical Center
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Tel Aviv, 이스라엘, 64239
- Tel Aviv Sourasky Medical Center
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Abano Terme, 이탈리아, 35031
- Policlinico Abano Terme
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Acquaviva delle Fonti, 이탈리아, 70021
- Generale Regionale F. Miulli
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Bassano del Grappa, 이탈리아, 36061
- Ospedale di Bassano del Grappa
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Brescia, 이탈리아, 25123
- ASST Spedali Civili Brescia
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Chieti, 이탈리아, 66100
- ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti
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Florence, 이탈리아, 50134
- Azienda Ospedaliero Universitaria Careggi
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Milan, 이탈리아, 20132
- Ospedale San Raffaele
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Milan, 이탈리아, 20141
- Istituto Europeo di Oncologia
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Milan, 이탈리아, 20127
- San Raffaele Turro - Istituto di Ricovero e Cura a Carattere Scientifico
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Modena, 이탈리아, 41100
- Clinica di Urologia Policlinico di Modena - Universita di Modena e reggio Emilia
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Novara, 이탈리아, 28100
- Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara
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Orbassano, 이탈리아, 10043
- Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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Roma, 이탈리아, 00144
- Istituto Nazionale Tumori Regina Elena
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Roma, 이탈리아, 00189
- Azienda Ospedaliera Sant Andrea
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Roma, 이탈리아, 00128
- Universita Campus Bio-Medico di Roma
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Torino, 이탈리아, 10126
- Ospedale Molinette, AO Città della Salute e della Scienza di
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Verona, 이탈리아, 37126
- UOC di Urologia AOU Integrata di Verona - Polo Chirurgico Confortini - Ospedale Borgo Trento
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Akita, 일본, 010-8543
- Akita University Hospital
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Chiba, 일본, 260 8677
- Chiba University Hospital
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Chūōku, 일본, 260-8717
- Chiba Cancer Center
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Hakodate, 일본, 040 8611
- Hakodate Goryoukaku Hospital
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Hirosaki, 일본, 036-8203
- Hirosaki University Hospital
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Kanazawa, 일본, 920 8641
- Kanazawa University Hospital
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Kobe, 일본, 650-0047
- Kobe City Medical Center General Hospital
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Koshigaya, 일본, 343-8555
- Dokkyo Medical University Saitama Medical Center
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Kurume, 일본, 830-0011
- Kurume University Hospital
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Kyoto, 일본, 606-8507
- Kyoto University Hospital
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Matsuyama, 일본, 791-0280
- National Hospital Organization Shikoku Cancer Center
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Minamiku, 일본, 252-0375
- Kitasato University Hospital
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Miyazaki, 일본, 889-1692
- University of Miyazaki Hospital
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Nagano, 일본, 381-8551
- Nagano Municipal Hospital
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Osaka, 일본, 541 8567
- Osaka International Cancer Institute
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Sakai, 일본, 590 0197
- Kindai University Hospital
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Sakura, 일본, 285-8741
- Toho University Sakura Medical Center
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Sapporo, 일본, 060-8648
- Hokkaido University Hospital
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Shiwa-gun, 일본, 028-3695
- Iwate Medical University Hospital
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Tokyo, 일본, 113-8421
- Juntendo University Hospital
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Tokyo, 일본, 113 8603
- Nippon Medical School Hospital
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Ube, 일본, 755-8505
- Yamaguchi University Hospital
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Yokohama, 일본, 232 0024
- Yokohama City University Medical Center
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Hradec Králove, 체코, 500 05
- Fakultni nemocnice Hradec Kralove
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Liberec, 체코, 460 63
- Krajská nemocnice Liberec
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Olomouc, 체코, 77200
- Uromedical Center s.r.o.
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Pilsen, 체코, 305 99
- Fakultni nemocnice Plzen, Urologicka klinika
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Prague, 체코, 140 59
- Thomayerova nemocnice
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Prague, 체코, 120 00
- Vseobecna fakultni nemocnice v Praze
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Alberta
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Calgary, Alberta, 캐나다, T2V 1P9
- Prostate Cancer Centre
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British Columbia
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Vancouver, British Columbia, 캐나다, 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, 캐나다, B3H 2Y9
- Nova Scotia Health Authority
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Ontario
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London, Ontario, 캐나다, N6A 5W9
- London Health Sciences Center
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Toronto, Ontario, 캐나다, M5G2M9
- Princess Margaret Cancer Centre University Health Network
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Toronto, Ontario, 캐나다, M4N 3M5
- Sunnybrook Health Sciences Center
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Quebec
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Montreal, Quebec, 캐나다, H2X 0A9
- CHUM - Centre hospitalier universitaire de Montreal
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Québec, Quebec, 캐나다, G1R 2J6
- CHU de Quebec Universite Laval Hopital de l Enfant Jesus
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Bydgoszcz, 폴란드, 85 094
- Szpital Uniwersytecki NR 1 IM Dr Antoniego Jurasza
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Bydgoszcz, 폴란드, 85 015
- Samodzielny Publiczny Wielospecjalistyczny Zaklad Opieki Zdrowotnej Mswia W Bydgoszczy
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Koszalin, 폴란드, 75 581
- Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie
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Krakow, 폴란드, 30-727
- Pratia MCM Krakow
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Warsaw, 폴란드, 02-473
- City Clinic Sp. z o.o.
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Wroclaw, 폴란드, 53-413
- Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - Urologia
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Angers, 프랑스, 49933
- CHU d'Angers
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Besançon, 프랑스, 25030
- CHRU Besancon Hopital Jean Minjoz
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Bordeaux, 프랑스, 33076
- Hopital Pellegrin CHU Bordeaux
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Créteil, 프랑스, 94010
- APHP - Hopital Henri Mondor
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Lyon, 프랑스, 69437
- Hopital Edouard Herriot - CHU Lyon
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Nantes, 프랑스, 44000
- CHU de Nantes hotel Dieu
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Paris, 프랑스, 75014
- Institut Mutualiste Montsouris
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Quint-Fonsegrives, 프랑스, 31130
- Clinique de la Croix du Sud
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Rennes, 프랑스, 35033
- Chu Rennes Hopital Pontchaillou
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Toulouse, 프랑스, 31059
- CHU de Toulouse - Hôpital Rangueil
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Tours, 프랑스, 37000
- CHRU Tours Hopital Bretonneau
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Box Hill, 호주, 3128q
- Eastern Health - Box Hill Hospital
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Darlinghurst, 호주, 2010
- St Vincent s Hospital Sydney
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Heidelberg, 호주, 3084
- Austin Health
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Malvern, 호주, 3144
- Australian Urology Associates Pty Ltd
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Parkville, 호주, 3052
- Royal Melbourne Hospital
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St Leonards, 호주, 2065
- Northern Cancer Institute
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Wahroonga, 호주, 2076
- Sydney Adventist Hospital
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Westmead, 호주, 2145
- Westmead Hospital
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Woolloongabba, 호주, 4102
- Princess Alexandra Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
남성
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
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]). |
|
실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants with Pathologic complete response (pCR)
기간: 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)
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Prostate Specific Antigen (PSA)-Free Survival
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2019년 6월 11일
기본 완료 (추정된)
기본 완료
2026년 12월 1일
연구 완료 (추정된)
연구 완료
2028년 10월 13일
연구 등록 날짜
최초 제출
최초 제출
2018년 12월 5일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2018년 12월 5일
처음 게시됨 (실제)
처음 게시됨
2018년 12월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 11월 3일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 11월 2일
마지막으로 확인됨
마지막으로 확인됨
2026년 11월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- CR108535
- 2018 (미국 NIH 보조금/계약)
- 56021927PCR3011 (기타 식별자: Janssen Research & Development, LLC)
- 2018-001746-34 (EudraCT 번호)
- 2023-506153-38-00 (레지스트리 식별자: EUCT number)
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .