PROTEUS: A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03767244
Collaborator
(none)
2,400
225
2
93.9
10.7
0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

High-risk prostate cancer accounts for approximately 15 percent (%) of newly diagnosed prostate cancers. A systemic therapy that eradicates micrometastatic disease is needed to improve survival in high-risk participants undergoing RP with pLND. It is hypothesized that androgen blockade prior to and after RP with pLND may improve outcomes for participants at the highest risk for recurrence. This study is designed to evaluate if androgen blockade administered prior to and after RP with pLND will increase the rate of pathological complete response (pCR) and lead to better overall outcomes. ERLEADA (apalutamide, also known as JNJ-56021927 and ARN-509) is an orally available, non-steroidal small molecule, which acts as a potent and selective antagonist of the androgen receptor (AR), currently being developed for the treatment of prostate cancer. The study includes screening phase (approximately up to 35 days before randomization), treatment phase (the planned Treatment Phase will include a total of 12 treatment cycles of apalutamide or placebo; 6 cycles prior to RP with pLND (Cycle 1 through Cycle 6) and 6 cycles after RP with pLND (Cycle 7 through Cycle 12). Cycle 1 Day 1 will start within 3 days after randomization) and follow-up phase. The end of study (study completion) is defined as last participant assessment at study site with approximate study duration of 8 years. Participants will undergo efficacy, pharmacokinetics and biomarker evaluations. The safety will be monitored throughout the study. An open-label sub-study comparing apalutamide plus ADT before and after RP with pLND with standard of care treatment will be initiated at selected sites upon notification by the sponsor.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Actual Study Start Date :
Jun 11, 2019
Anticipated Primary Completion Date :
Apr 22, 2024
Anticipated Study Completion Date :
Apr 7, 2027

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Apalutamide
Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.
Other Names:
  • JNJ-56021927
  • Drug: 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.

    Drug: 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]).

    Drug: Placebo
    Participants will receive matching placebo oral tablets daily.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with Pathologic complete response (pCR) [Approximately 4 years]

      pCR is assessed by a pathology blinded independent central radiology review (BICR) as defined in the pathology charter.

    2. Metastasis-Free Survival (MFS) [Up to 7 years and 5 months]

      MFS is defined as the time from randomization to the date of the first occurrence of radiographic distant metastasis evaluated by radiology BICR, incidental pathologic finding of distant metastasis, or death from any cause, whichever occurs first.

    Secondary Outcome Measures

    1. Prostate Specific Antigen (PSA)-Free Survival [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.

    2. Event Free Survival (EFS) [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.

    3. Time to Subsequent First Treatments (TTST-1) [Up to 7 years and 5 months]

      TTST-1 is defined as the time from randomization to the date of first subsequent therapy.

    4. Time to Distant Metastasis (TTDM) [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.

    5. MFS Based on Conventional Imaging [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.

    6. Number of Participants with Adverse Events [Up to 30 days after last dose of study drug (Approximately 8 years)]

      An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

    7. Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability [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.

    8. Number of Participants with Vital Signs Abnormalities as a Measure of Safety and Tolerability [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.

    9. Number of Participants with Physical Examinations Abnormalities as a Measure of Safety and Tolerability [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.

    10. Number of Participants with Treatment Compliance Rate [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UC San Diego Moores Cancer Center La Jolla California United States 92093
    2 University of Southern California Los Angeles California United States 90033
    3 Cedars-Sinai Medical Center Los Angeles California United States 90048
    4 University of California Los Angeles Los Angeles California United States 90095
    5 University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center Orange California United States 92868
    6 UC Davis Medical Center Sacramento California United States 95817
    7 The Urology Center of Colorado Denver Colorado United States 80211
    8 Colorado Clinical Research Lakewood Colorado United States 80228
    9 Yale Cancer Center New Haven Connecticut United States 06510
    10 Stamford Hospital Stamford Connecticut United States 06904
    11 Urology Specialists LLC Hialeah Florida United States 33002
    12 University of Florida Jacksonville Florida United States 32209
    13 Mayo Clinic - Division Of Hematology/oncology Jacksonville Florida United States 32224
    14 Miami Cancer Institute at Baptist Health / Baptist Health Medical Group Miami Florida United States 33176
    15 Florida Hospital Orlando Florida United States 32804
    16 Emory University - Winship Cancer Institute Atlanta Georgia United States 30322-1013
    17 University of Chicago Chicago Illinois United States 60637
    18 DuPage Medical Group Lisle Illinois United States 60532
    19 Wichita Urology Group Wichita Kansas United States 67226
    20 Tulane University School of Medicine New Orleans Louisiana United States 70112
    21 Ochsner LSU Health Shreveport - Regional Urology Shreveport Louisiana United States 71106
    22 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    23 Beth Isreal Deaconess Medical Center Boston Massachusetts United States 02215
    24 Michigan Institute of Urology, PC Troy Michigan United States 48084
    25 Saint Louis University Saint Louis Missouri United States 63110
    26 Washington University Saint Louis Missouri United States 63110
    27 Urology Cancer Center, PC Omaha Nebraska United States 68130
    28 New Hampshire Oncology Hematology, PA Hooksett New Hampshire United States 03106
    29 Garden State Urology Morristown New Jersey United States 07960
    30 Albany Medical College Albany New York United States 12208
    31 Great Lakes Physician PC d/b/a Western New York Urology Associates Cheektowaga New York United States 14225
    32 Icahn School of Medicine at Mount Sinai New York New York United States 10029
    33 Memorial Sloan-Kettering Cancer Center New York New York United States 10065
    34 Weill Cornell Medical College New York New York United States 10065
    35 SUNY Upstate Medical University Syracuse New York United States 13210
    36 University of North Carolina Chapel Hill North Carolina United States 27599
    37 Duke University School of Medicine Durham North Carolina United States 27705
    38 Medication Management, LLC Greensboro North Carolina United States 27403
    39 Carolina Urology Partners, PLLC Huntersville North Carolina United States 28078
    40 Cleveland VA Medical Center Cleveland Ohio United States 44106
    41 University of Toledo Toledo Ohio United States 43614
    42 Oklahoma City VAMC Oklahoma City Oklahoma United States 73104
    43 Oklahoma University Health Science Center Oklahoma City Oklahoma United States 73104
    44 MidLantic Urology Bala-Cynwyd Pennsylvania United States 19004
    45 Penn State Health Hershey Pennsylvania United States 17033
    46 Omega Medical Research Warwick Rhode Island United States 02886
    47 Medical University of South Carolina Charleston South Carolina United States 29403
    48 Ralph H. Johnson Veterans Affairs Medical Center Charleston South Carolina United States 29425
    49 Greenville Health Greenville South Carolina United States 29605
    50 Carolina Urologic Research Center Myrtle Beach South Carolina United States 29572
    51 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    52 VA North Texas Health Care System Dallas Texas United States 75216
    53 Texas Oncology P.A. Houston Texas United States 77024
    54 MD Anderson Cancer Center Houston Texas United States 77030
    55 Texas Oncology Plano Texas United States 75024
    56 Virginia Urology Richmond Virginia United States 23235
    57 Urology of Virginia, PLCC Virginia Beach Virginia United States 23462
    58 University of Washington School of Medicine Seattle Washington United States 98195
    59 CAMC Memorial Hospital, Charleston Area Medical Center Physicians Charleston West Virginia United States 25304
    60 Hospital Aleman Caba Argentina 1118
    61 Hospital Italiano de Buenos Aires Ciudad Autonoma de Argentina C1199ABB
    62 Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica Cordoba Argentina 5000
    63 Centro Urologico Profesor Bengio Cordoba Argentina X5000KPH
    64 Uroclinica Mendoza Argentina 5500
    65 Hospital Italiano de Rosario Rosario Argentina 2000
    66 Clinica Mayo de UMCB San Miguel de Tucuman Argentina 4000
    67 Epworth Eastern Hospital Box Hill Australia 3128q
    68 St. Vincent's Hospital Sydney Darlinghurst Australia 2010
    69 Austin Health Heidelberg Australia 3084
    70 Australian Urology Associates Pty Ltd Malvern Australia 3144
    71 Royal Melbourne Hospital Parkville Australia 3050
    72 Northern Cancer Institute St Leonards Australia 2065
    73 Australian Clinical Trials - SAN Clinic Wahroonga Australia 2076
    74 Westmead Hospital Westmead Australia 2145
    75 Princess Alexandra Hospital Woolloongabba Australia 4102
    76 Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará Fortaleza Brazil 60430-230
    77 Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás Goiânia Brazil 74605-070
    78 Hospital de Caridade de Ijui - CACON Ijui Brazil 98700-000
    79 Liga Norte Riograndense Contra O Cancer Natal Brazil 59075-740
    80 Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre Brazil 90020-090
    81 Hospital Universitário Pedro Ernesto Rio de Janeiro Brazil 20551-030
    82 ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA Sao Paulo Brazil 01246-000
    83 Hospital Samaritano de São Paulo São Paulo Brazil 01243-020
    84 Instituto Do Cancer Brasil Três Lagoas Brazil 79601-001
    85 Prostate Cancer Centre Calgary Alberta Canada T2V 1P9
    86 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    87 Exdeo Clinical Research Inc Abbotsford British Columbia Canada V2S 3N5
    88 Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre Vancouver British Columbia Canada V5Z 1M9
    89 Nova Scotia Health Authority Halifax Nova Scotia Canada B3H 2Y9
    90 McMaster Institute of Urology Hamilton Ontario Canada L8N 4A6
    91 London Health Sciences Center London Ontario Canada N6A 5W9
    92 Sunnybrook Health Sciences Center Toronto Ontario Canada M4N 3M5
    93 University Health Network (UHN) Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9
    94 CHUM - Centre hospitalier universitaire de Montreal Montreal Quebec Canada H2X 0A9
    95 CHU de Québec-Université Laval-Hôpital de l'Enfant-Jésus Quebec Canada G1R 2J6
    96 Fakultni nemocnice Hradec Kralove Hradec Králove Czechia 500 05
    97 Krajská nemocnice Liberec Liberec Czechia 460 63
    98 Uromedical Center s.r.o. Olomouc Czechia 77200
    99 Fakultni nemocnice Plzen, Urologicka klinika Plzen Czechia 305 99
    100 Thomayerova nemocnice Praha 4 Czechia 140 59
    101 Vseobecna fakultni nemocnice v Praze Praha Czechia 120 00
    102 CHU d'Angers Angers France 49933
    103 CHRU Besançon -Hôpital Jean Minjoz Besançon Cedex France 25030
    104 Hôpital Pellegrin CHU Bordeaux Bordeaux N/a France 33076
    105 APHP - Hopital Henri Mondor Créteil France 94010
    106 Hopital Edouard Herriot - CHU Lyon Lyon cedex 03 France 69437
    107 CHU de Nantes hôtel-Dieu Nantes France 44000
    108 Institut Mutualiste Montsouris Paris France 75014
    109 Clinique de la Croix du Sud Quint-Fonsegrives France 31130
    110 Chu Rennes - Hopital Pontchaillou Rennes Cedex France 35033
    111 CHU de Toulouse - Hôpital Rangueil Toulouse Cedex 9 France 31059
    112 CHRU Tours Hôpital Bretonneau Tours France 37000
    113 Universitaetsklinikum der RWTH Aachen Aachen Germany 52074
    114 Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer Braunschweig Germany 38126
    115 Universitatsklinikum Essen Essen Germany 45147
    116 Universitatsklinikum Frankfurt Frankfurt am Main Germany 60590
    117 Prostata zentrum Nordwest Gronau Germany 48599
    118 Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie Hamburg Germany 20246
    119 Urologikum Hamburg Hamburg Germany 22399
    120 Universitätsklinikum des Saarlandes Homburg/Saar Germany 66421
    121 Universitaetsklinikum Koeln Koeln Germany 50937
    122 Universitätsklinikum Schleswig Holstein Campus Lübeck Lubeck Germany 23538
    123 Praxis Dr. med. Ralf Eckert Lutherstadt Eisleben Germany 06295
    124 Klinikum St. Elisabeth Straubing GmbH Straubing Germany 94315
    125 Kliniken Nordoberpfalz, Klinik für Urologie Weiden/Opf Germany 92637
    126 Praxisgemeinschaft f. Onkologie u. Urologie - Germany Wilhelmshaven Germany 26389
    127 Asaf Harofe Medical Center Beer Yaakov Israel 60930
    128 Rambam Health Care Campus Haifa Israel 31096
    129 Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC) Kfar Saba Israel 4428164
    130 Rabin Medical Center Petach Tikva Israel 49100
    131 The Chaim Sheba Medical Center Ramat Gan Israel 52621
    132 Tel Aviv Sourasky Medical Center Tel Aviv Israel 64239
    133 Policlinico Abano Terme Abano Terme Italy 35031
    134 Generale Regionale F. Miulli Acquaviva delle Fonti Italy 70021
    135 Ospedale di Bassano del Grappa Bassano del Grappa Italy 36061
    136 ASST Spedali Civili Brescia Brescia Italy 25123
    137 ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti Chieti Italy 66100
    138 Azienda Ospedaliero Universitaria Careggi Firenze Italy 50134
    139 San Raffaele Turro - Istituto di Ricovero e Cura a Carattere Scientifico MIlano Italy 20127
    140 Ospedale San Raffaele Milano Italy 20132
    141 Istituto Europeo di Oncologia Milano Italy 20141
    142 Clinica di Urologia Policlinico di Modena - Università di Modena e reggio Emilia Modena Italy 41100
    143 Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara Novara Italy 28100
    144 Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy 10043
    145 Università Campus Bio-Medico di Roma Roma Italy 00128
    146 Istituto Nazionale Tumori Regina Elena Roma Italy 00144
    147 Azienda Ospedaliera Sant Andrea Roma Italy 00189
    148 Ospedale Molinette, AO Città della Salute e della Scienza di Torino Italy 10126
    149 UOC di Urologia AOU Integrata di Verona - Polo Chirurgico Confortini - Ospedale Borgo Trento Verona Italy 37126
    150 Akita University Hospital Akita Japan 010-8543
    151 Chiba University Hospital Chiba Japan 260-8677
    152 Chiba Cancer Center Chuo-ku, Chiba-City, Japan 260-8717
    153 Hakodate Goryokaku Hospital Hakodate Japan 040-8611
    154 Hirosaki University Hospital Hirosaki Japan 036-8203
    155 Kanazawa University Hospital Kanazawa Japan 920-8641
    156 Kobe City Medical Center General Hospital Kobe Japan 650-0047
    157 Dokkyo Medical University Saitama Medical Center Koshigaya Japan 343-8555
    158 Kurume University Hospital Kurume Japan 830-0011
    159 Kyoto University Hospital Kyoto Japan 606-8507
    160 National Hospital Organizaiton Shikoku Cancer Center Matsuyama Japan 791-0280
    161 Kitasato University Hospital Minami-Ku, Sagamihara-Shi Japan 252-0375
    162 University of Miyazaki Hospital Miyazaki Japan 889-1692
    163 Nagano Municipal Hospital Nagano Japan 381-8551
    164 Kindai University Hospital Osaka-Sayama-shi Japan 589-8511
    165 Osaka International Cancer Institute Osaka Japan 541-8567
    166 Toho University Sakura Medical Center Sakura Japan 285-8741
    167 Hokkaido University Hospital Sapporo-shi Japan 060-8648
    168 Iwate Medical University Hospital Shiwa-gun Japan 028-3695
    169 Juntendo University Hospital Tokyo Japan 113-8421
    170 Nippon Medical School Hospital Tokyo Japan 113-8603
    171 Yamaguchi University Hospital Ube Japan 755-8505
    172 Yokohama City University Medical Center Yokohama Japan 232-0024
    173 Chonnam National University Hospital Gwangju Korea, Republic of 61469
    174 Seoul National University Bundang Hospital Gyeonggi-do Korea, Republic of 13605
    175 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    176 Asan Medical Center Seoul Korea, Republic of 05505
    177 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of 06591
    178 NKI-AVL, Amsterdam Amsterdam Netherlands 1066 CX
    179 Catharinaziekenhuis Eindhoven Netherlands 5623 EJ
    180 St. Antonius Ziekenhuis (St. Antonius Hospital) Nieuwegein Netherlands 3430EM
    181 Canisius-Wilhelmina Ziekenhuis Nijmegen Netherlands 6524 KD
    182 Samodzielny Publiczny Wielospecjalistyczny Zakład Opieki Zdrowotnej MSWiA w Bydgoszczy Bydgoszcz Poland 85-015
    183 Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza Bydgoszcz Poland 85-094
    184 Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie Koszalin Poland 75-581
    185 Pratia MCM Krakow Krakow Poland 30-510
    186 City Clinic Sp. z o.o. Warszawa Poland 02-473
    187 Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - Urologia Wrocław Poland 53-413
    188 Altai Regional Oncology Dispensary Barnaul Russian Federation 656049
    189 Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine Chelyabinsk Russian Federation 454087
    190 Moscow City Clinical Hospital # 62 Moscow Russian Federation 125130
    191 Botkin City Clinical Hospital Moscow Russian Federation 125284
    192 Hertzen Oncology Research Institute Moscow Russian Federation 125284
    193 Clinical Oncology Dispensary Omsk Russian Federation 644013
    194 Medical-sanitary unit 'Neftyanik' Tyumen Russian Federation 625000
    195 Vologda Regional Oncological Dispensary Vologda Russian Federation 160012
    196 Hosp. Univ. A Coruña A Coruña Spain 15006
    197 Hosp. Univ. Vall D Hebron Barcelona Spain 8035
    198 Hosp. Puerta Del Mar Cadiz Spain 11009
    199 Hosp. Gral. Univ. de Castellon Castellón Spain 12004
    200 Hosp. de Jerez de La Frontera Jerez de la Frontera Spain 11407
    201 Hosp. Univ. Ramon Y Cajal Madrid Spain 28034
    202 Hosp. Univ. 12 de Octubre Madrid Spain 28041
    203 Hosp. Univ. La Paz Madrid Spain 28046
    204 Fund. Hosp. de Manacor Manacor Spain 07500
    205 Hosp. Virgen de La Victoria Málaga Spain 29010
    206 Hosp. Univ. Marques de Valdecilla Santander Spain 39008
    207 Hosp. Virgen Del Rocio Sevilla Spain 41013
    208 Inst. Valenciano de Oncologia Valencia Spain 46009
    209 Hosp. Clinico Univ. de Valencia Valencia Spain 46010
    210 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 807
    211 China Medical University Hospital Taichung Taiwan 40447
    212 Taichung Veterans General Hospital Taichung Taiwan 40705
    213 Tungs' Taichung MetroHarbor Hospital Taichung Taiwan 435
    214 Chi Mei Medical Center - Yong Kang Tainan Taiwan 710
    215 National Taiwan University Hospital. Taipei Taiwan 10002
    216 Southmead Hospital Bristol United Kingdom BS10 5NB
    217 University Hospital of Wales Cardiff United Kingdom CF14 4XW
    218 Ninewells Hospital Dundee United Kingdom DD2 1UB
    219 The Royal Marsden NHS Trust London United Kingdom SW3 6JJ
    220 University College London London United Kingdom WC1E 6BT
    221 Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital Preston United Kingdom PR2 9HT
    222 Southampton General Hospital Southampton United Kingdom SO16 6YD
    223 Royal Marsden Hospital Sutton United Kingdom SM2 5PT
    224 MidYorkshire NHS Trust Wakefield United Kingdom WF1 4DG
    225 New Cross Hospital Wolverhampton United Kingdom WV10 0QP

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT03767244
    Other Study ID Numbers:
    • CR108535
    • 56021927PCR3011
    • 2018-001746-34
    First Posted:
    Dec 6, 2018
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 3, 2022