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)
2,000
Enrollment
225
Locations
2
Arms
80.1
Anticipated Duration (Months)
8.9
Patients Per Site
0.1
Patients Per Site Per Month

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) based on conventional imaging, as compared to placebo plus ADT.

Condition or DiseaseIntervention/TreatmentPhase
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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2000 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 :
Feb 11, 2026

Arms and Interventions

ArmIntervention/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 on conventional imaging [that is, computed tomography (CT)/magnetic resonance imaging (MRI) and bone scan]) 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. Progression-Free Survival (PFS) [Approximately 8 years]

      PFS is defined as the time from randomization to first documentation of BICR confirmed radiographic progressive disease or death due to any cause (whichever occurs first) plus 1 day. Progressive disease will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. As per RECIST v1.1. Unequivocal local-regional progression/recurrence or the distant metastasis observed on CT or MRI scans or identified by biopsy will be considered progression. Local-regional progression/recurrence is defined as local tumor recurrence in the prostate bed or occurrence of at least one new regional lymph node.

    3. 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.

    4. 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.

    5. 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.

    6. 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 subject, 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.

    7. 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 men and female partners of men 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

    SiteCityStateCountryPostal Code
    1UC San Diego Moores Cancer CenterLa JollaCaliforniaUnited States92093
    2University of Southern CaliforniaLos AngelesCaliforniaUnited States90033
    3Cedars-Sinai Medical CenterLos AngelesCaliforniaUnited States90048
    4University of California Los AngelesLos AngelesCaliforniaUnited States90095
    5University of California Irvine Medical Center - Chao Family Comprehensive Cancer CenterOrangeCaliforniaUnited States92868
    6UC Davis Medical CenterSacramentoCaliforniaUnited States95817
    7The Urology Center of ColoradoDenverColoradoUnited States80211
    8Colorado Clinical ResearchLakewoodColoradoUnited States80228
    9Yale Cancer CenterNew HavenConnecticutUnited States06510
    10Stamford HospitalStamfordConnecticutUnited States06904
    11Urology Specialists LLCHialeahFloridaUnited States33002
    12University of FloridaJacksonvilleFloridaUnited States32209
    13Mayo Clinic - Division Of Hematology/oncologyJacksonvilleFloridaUnited States32224
    14Miami Cancer Institute at Baptist Health / Baptist Health Medical GroupMiamiFloridaUnited States33176
    15Florida HospitalOrlandoFloridaUnited States32804
    16Emory University - Winship Cancer InstituteAtlantaGeorgiaUnited States30322-1013
    17University of ChicagoChicagoIllinoisUnited States60637
    18DuPage Medical GroupLisleIllinoisUnited States60532
    19Wichita Urology GroupWichitaKansasUnited States67226
    20Tulane University School of MedicineNew OrleansLouisianaUnited States70112
    21Regional UrologyShreveportLouisianaUnited States71106
    22Dana-Farber Cancer InstituteBostonMassachusettsUnited States02115
    23Beth Isreal Deaconess Medical CenterBostonMassachusettsUnited States02215
    24Michigan Institute of Urology, PCTroyMichiganUnited States48084
    25Saint Louis UniversitySaint LouisMissouriUnited States63110
    26Washington UniversitySaint LouisMissouriUnited States63110
    27Urology Cancer Center, PCOmahaNebraskaUnited States68130
    28New Hampshire Oncology Hematology, PAHooksettNew HampshireUnited States03106
    29Garden State UrologyMorristownNew JerseyUnited States07960
    30Albany Medical CollegeAlbanyNew YorkUnited States12208
    31Great Lakes Physician PC d/b/a Western New York Urology AssociatesCheektowagaNew YorkUnited States14225
    32Icahn School of Medicine at Mount SinaiNew YorkNew YorkUnited States10029
    33Memorial Sloan-Kettering Cancer CenterNew YorkNew YorkUnited States10065
    34Weill Cornell Medical CollegeNew YorkNew YorkUnited States10065
    35SUNY Upstate Medical UniversitySyracuseNew YorkUnited States13210
    36University of North CarolinaChapel HillNorth CarolinaUnited States27599
    37Duke University School of MedicineDurhamNorth CarolinaUnited States27705
    38Medication Management, LLCGreensboroNorth CarolinaUnited States27403
    39Carolina Urology Partners, PLLCHuntersvilleNorth CarolinaUnited States28078
    40Cleveland VA Medical CenterClevelandOhioUnited States44106
    41University of ToledoToledoOhioUnited States43614
    42Oklahoma City VAMCOklahoma CityOklahomaUnited States73104
    43Oklahoma University Health Science CenterOklahoma CityOklahomaUnited States73104
    44MidLantic UrologyBala-CynwydPennsylvaniaUnited States19004
    45Penn State HealthHersheyPennsylvaniaUnited States17033
    46Omega Medical ResearchWarwickRhode IslandUnited States02886
    47Medical University of South CarolinaCharlestonSouth CarolinaUnited States29403
    48Ralph H. Johnson Veterans Affairs Medical CenterCharlestonSouth CarolinaUnited States29425
    49Greenville HealthGreenvilleSouth CarolinaUnited States29605
    50Carolina Urologic Research CenterMyrtle BeachSouth CarolinaUnited States29572
    51Vanderbilt University Medical CenterNashvilleTennesseeUnited States37232
    52VA North Texas Health Care SystemDallasTexasUnited States75216
    53Texas Oncology P.A.HoustonTexasUnited States77024
    54MD Anderson Cancer CenterHoustonTexasUnited States77030
    55Texas OncologyPlanoTexasUnited States75024
    56Virginia UrologyRichmondVirginiaUnited States23235
    57Urology of Virginia, PLCCVirginia BeachVirginiaUnited States23462
    58University of Washington School of MedicineSeattleWashingtonUnited States98195
    59CAMC Memorial Hospital, Charleston Area Medical Center PhysiciansCharlestonWest VirginiaUnited States25304
    60Hospital AlemanCabaArgentina1118
    61Hospital Italiano de Buenos AiresCiudad Autonoma deArgentinaC1199ABB
    62Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion ClinicaCordobaArgentina5000
    63Centro Urologico Profesor BengioCordobaArgentinaX5000KPH
    64UroclinicaMendozaArgentina5500
    65Hospital Italiano de RosarioRosarioArgentina2000
    66Clinica Mayo de UMCBSan Miguel de TucumanArgentina4000
    67Epworth Eastern HospitalBox HillAustralia3128q
    68St. Vincent's Hospital SydneyDarlinghurstAustralia2010
    69Austin HealthHeidelbergAustralia3084
    70Australian Urology Associates Pty LtdMalvernAustralia3144
    71Royal Melbourne HospitalParkvilleAustralia3050
    72Northern Cancer InstituteSt LeonardsAustralia2065
    73Australian Clinical Trials - SAN ClinicWahroongaAustralia2076
    74Westmead HospitalWestmeadAustralia2145
    75Princess Alexandra HospitalWoolloongabbaAustralia4102
    76Hospital Haroldo Juaçaba - Instituto do Câncer do CearáFortalezaBrazil60430-230
    77Hospital Araújo Jorge da Associação de Combate ao Câncer em GoiásGoiâniaBrazil74605-070
    78Hospital de Caridade de Ijui - CACONIjuiBrazil98700-000
    79Liga Norte Riograndense Contra O CancerNatalBrazil59075-740
    80Irmandade Santa Casa de Misericordia de Porto AlegrePorto AlegreBrazil90020-090
    81Hospital Universitário Pedro ErnestoRio de JaneiroBrazil20551-030
    82ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRASao PauloBrazil01246-000
    83Hospital Samaritano de São PauloSão PauloBrazil01243-020
    84Instituto Do Cancer BrasilTrês LagoasBrazil79601-001
    85Prostate Cancer CentreCalgaryAlbertaCanadaT2V 1P9
    86Cross Cancer InstituteEdmontonAlbertaCanadaT6G 1Z2
    87Exdeo Clinical Research IncAbbotsfordBritish ColumbiaCanadaV2S 3N5
    88Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care CentreVancouverBritish ColumbiaCanadaV5Z 1M9
    89Nova Scotia Health AuthorityHalifaxNova ScotiaCanadaB3H 2Y9
    90McMaster Institute of UrologyHamiltonOntarioCanadaL8N 4A6
    91London Health Sciences CenterLondonOntarioCanadaN6A 5W9
    92Sunnybrook Health Sciences CenterTorontoOntarioCanadaM4N 3M5
    93University Health Network (UHN) Princess Margaret Cancer CentreTorontoOntarioCanadaM5G 2M9
    94CHUM - Centre hospitalier universitaire de MontrealMontrealQuebecCanadaH2X 0A9
    95CHUQ - CHU de QuebecQuebecCanadaG1R 2J6
    96Fakultni nemocnice Hradec KraloveHradec KráloveCzechia500 05
    97Krajská nemocnice LiberecLiberecCzechia460 63
    98Uromedical Center s.r.o.OlomoucCzechia77200
    99Fakultni nemocnice Plzen, Urologicka klinikaPlzenCzechia305 99
    100Thomayerova nemocnicePraha 4Czechia140 59
    101Vseobecna fakultni nemocnice v PrazePrahaCzechia120 00
    102CHU d'AngersAngersFrance49933
    103CHRU Besançon -Hôpital Jean MinjozBesançon CedexFrance25030
    104Hôpital Pellegrin CHU BordeauxBordeaux N/aFrance33076
    105APHP - Hopital Henri MondorCréteilFrance94010
    106Hopital Edouard Herriot - CHU LyonLyon cedex 03France69437
    107CHU de Nantes hôtel-DieuNantesFrance44000
    108Institut Mutualiste MontsourisParisFrance75014
    109Clinique de la Croix du SudQuint-FonsegrivesFrance31130
    110Chu Rennes - Hopital PontchaillouRennes CedexFrance35033
    111CHU de Toulouse - Hôpital RangueilToulouse Cedex 9France31059
    112CHRU Tours Hôpital BretonneauToursFrance37000
    113Universitaetsklinikum der RWTH AachenAachenGermany52074
    114Städtisches Klinikum Braunschweig gGmbH - Standort SalzdahlumerBraunschweigGermany38126
    115Universitatsklinikum EssenEssenGermany45147
    116Universitatsklinikum FrankfurtFrankfurt am MainGermany60590
    117Prostata zentrum NordwestGronauGermany48599
    118Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf UrologieHamburgGermany20246
    119Urologikum HamburgHamburgGermany22399
    120Universitätsklinikum des SaarlandesHomburg/SaarGermany66421
    121Universitaetsklinikum KoelnKoelnGermany50937
    122Universitätsklinikum Schleswig Holstein Campus LübeckLubeckGermany23538
    123Praxis Dr. med. Ralf EckertLutherstadt EislebenGermany06295
    124Klinikum St. Elisabeth Straubing GmbHStraubingGermany94315
    125Kliniken Nordoberpfalz, Klinik für UrologieWeiden/OpfGermany92637
    126Praxisgemeinschaft f. Onkologie u. Urologie - GermanyWilhelmshavenGermany26389
    127Asaf Harofe Medical CenterBeer YaakovIsrael60930
    128Rambam Health Care CampusHaifaIsrael31096
    129Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC)Kfar SabaIsrael4428164
    130Rabin Medical CenterPetach TikvaIsrael49100
    131The Chaim Sheba Medical CenterRamat GanIsrael52621
    132Tel Aviv Sourasky Medical CenterTel AvivIsrael64239
    133Policlinico Abano TermeAbano TermeItaly35031
    134Generale Regionale F. MiulliAcquaviva delle FontiItaly70021
    135Ospedale di Bassano del GrappaBassano del GrappaItaly36061
    136ASST Spedali Civili BresciaBresciaItaly25123
    137ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di ChietiChietiItaly66100
    138Azienda Ospedaliero Universitaria CareggiFirenzeItaly50134
    139San Raffaele Turro - Istituto di Ricovero e Cura a Carattere ScientificoMIlanoItaly20127
    140Ospedale San RaffaeleMilanoItaly20132
    141Istituto Europeo di OncologiaMilanoItaly20141
    142Clinica di Urologia Policlinico di Modena - Università di Modena e reggio EmiliaModenaItaly41100
    143Università del Piemonte Orientale - Ospedale Maggiore della Carità di NovaraNovaraItaly28100
    144Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassanoItaly10043
    145Università Campus Bio-Medico di RomaRomaItaly00128
    146Istituto Nazionale Tumori Regina ElenaRomaItaly00144
    147Azienda Ospedaliera Sant AndreaRomaItaly00189
    148Ospedale Molinette, AO Città della Salute e della Scienza diTorinoItaly10126
    149UOC di Urologia AOU Integrata di Verona - Polo Chirurgico Confortini - Ospedale Borgo TrentoVeronaItaly37126
    150Akita University HospitalAkitaJapan010-8543
    151Chiba University HospitalChibaJapan260-8677
    152Chiba Cancer CenterChuo-ku, Chiba-City,Japan260-8717
    153Hakodate Goryokaku HospitalHakodateJapan040-8611
    154Hirosaki University HospitalHirosakiJapan036-8203
    155Kanazawa University HospitalKanazawaJapan920-8641
    156Kobe City Medical Center General HospitalKobeJapan650-0047
    157Dokkyo Medical University Saitama Medical CenterKoshigayaJapan343-8555
    158Kurume University HospitalKurumeJapan830-0011
    159Kyoto University HospitalKyotoJapan606-8507
    160National Hospital Organizaiton Shikoku Cancer CenterMatsuyamaJapan791-0280
    161Kitasato University HospitalMinami-Ku, Sagamihara-ShiJapan252-0375
    162University of Miyazaki HospitalMiyazakiJapan889-1692
    163Nagano Municipal HospitalNaganoJapan381-8551
    164Kindai University HospitalOsaka-Sayama-shiJapan589-8511
    165Osaka International Cancer InstituteOsakaJapan541-8567
    166Toho University Sakura Medical CenterSakuraJapan285-8741
    167Hokkaido University HospitalSapporo-shiJapan060-8648
    168Iwate Medical University HospitalShiwa-gunJapan028-3695
    169Juntendo University HospitalTokyoJapan113-8421
    170Nippon Medical School HospitalTokyoJapan113-8603
    171Yamaguchi University HospitalUbeJapan755-8505
    172Yokohama City University Medical CenterYokohamaJapan232-0024
    173Chonnam National University HospitalGwangjuKorea, Republic of61469
    174Seoul National University Bundang HospitalSeongnamKorea, Republic of13605
    175Severance Hospital, Yonsei University Health SystemSeoulKorea, Republic of03722
    176Asan Medical CenterSeoulKorea, Republic of05505
    177The Catholic University of Korea, Seoul St. Mary's HospitalSeoulKorea, Republic of06591
    178NKI-AVL, AmsterdamAmsterdamNetherlands1066 CX
    179CatharinaziekenhuisEindhovenNetherlands5623 EJ
    180St. Antonius Ziekenhuis (St. Antonius Hospital)NieuwegeinNetherlands3430EM
    181Canisius-Wilhelmina ZiekenhuisNijmegenNetherlands6524 KD
    182Samodzielny Publiczny Wielospecjalistyczny Zakład Opieki Zdrowotnej MSWiA w BydgoszczyBydgoszczPoland85-015
    183Szpital Uniwersytecki NR 1 IM. Dr. Antoniego JuraszaBydgoszczPoland85-094
    184Szpital Wojewódzki im. Mikołaja Kopernika w KoszalinieKoszalinPoland75-581
    185Pratia MCM KrakowKrakowPoland30-510
    186City Clinic Sp. z o.o.WarszawaPoland02-473
    187Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - UrologiaWrocławPoland53-413
    188Altai Regional Oncology DispensaryBarnaulRussian Federation656049
    189Chelyabinsk Regional Clinical Center Of Oncology And Nuclear MedicineChelyabinskRussian Federation454087
    190Moscow City Clinical Hospital # 62MoscowRussian Federation125130
    191Botkin City Clinical HospitalMoscowRussian Federation125284
    192Hertzen Oncology Research InstituteMoscowRussian Federation125284
    193Clinical Oncology DispensaryOmskRussian Federation644013
    194Medical-sanitary unit 'Neftyanik'TyumenRussian Federation625000
    195Vologda Regional Oncological DispensaryVologdaRussian Federation160012
    196Hosp. Univ. A CoruñaA CoruñaSpain15006
    197Hosp. Univ. Vall D HebronBarcelonaSpain8035
    198Hosp. Puerta Del MarCadizSpain11009
    199Hosp. Gral. Univ. de CastellonCastellónSpain12004
    200Hosp. de Jerez de La FronteraJerez de la FronteraSpain11407
    201Hosp. Univ. Ramon Y CajalMadridSpain28034
    202Hosp. Univ. 12 de OctubreMadridSpain28041
    203Hosp. Univ. La PazMadridSpain28046
    204Fund. Hosp. de ManacorManacorSpain07500
    205Hosp. Virgen de La VictoriaMálagaSpain29010
    206Hosp. Univ. Marques de ValdecillaSantanderSpain39008
    207Hosp. Virgen Del RocioSevillaSpain41013
    208Inst. Valenciano de OncologiaValenciaSpain46009
    209Hosp. Clinico Univ. de ValenciaValenciaSpain46010
    210Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiungTaiwan807
    211China Medical University HospitalTaichungTaiwan40447
    212Taichung Veterans General HospitalTaichungTaiwan40705
    213Tungs' Taichung MetroHarbor HospitalTaichungTaiwan435
    214Chi Mei Medical Center - Yong KangTainanTaiwan710
    215National Taiwan University Hospital.TaipeiTaiwan10002
    216Southmead HospitalBristolUnited KingdomBS10 5NB
    217University Hospital of WalesCardiffUnited KingdomCF14 4XW
    218Ninewells HospitalDundeeUnited KingdomDD2 1UB
    219The Royal Marsden NHS TrustLondonUnited KingdomSW3 6JJ
    220University College LondonLondonUnited KingdomWC1E 6BT
    221Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston HospitalPrestonUnited KingdomPR2 9HT
    222Southampton General HospitalSouthamptonUnited KingdomSO16 6YD
    223Royal Marsden HospitalSuttonUnited KingdomSM2 5PT
    224MidYorkshire NHS TrustWakefieldUnited KingdomWF1 4DG
    225New Cross HospitalWolverhamptonUnited KingdomWV10 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

    Additional 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:
    Nov 5, 2021
    Last Verified:
    Nov 1, 2021
    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 Nov 5, 2021