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Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

Sponsor
Pfizer (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02319837
Collaborator
Astellas Pharma Inc (Industry), Medivation LLC, a wholly owned subsidiary of Pfizer Inc. (Industry)
1,068
Enrollment
258
Locations
3
Arms
141.1
Anticipated Duration (Months)
4.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1068 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy
Actual Study Start Date :
Dec 17, 2014
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Sep 19, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Enzalutamide plus leuprolide

Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with leuprolide administered as as a single intramuscular or subcutaneous injection once every 12 weeks

Drug: Enzalutamide
Other Names:
  • MDV3100
  • Xtandi

    • Drug: Leuprolide
    Other Names:
  • Eligard
  • Leuprolide Acetate
  • Leuprorelin
  • Lupron

    		•
    Experimental: Enzalutamide monotherapy

    Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily

    Drug: Enzalutamide
    Other Names:
  • MDV3100
  • Xtandi

    		•
    Active Comparator: Placebo plus leuprolide

    Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with leuprolide administered as a single intramuscular or subcutaneous injection once every 12 weeks

    Drug: Placebo
    Sugar pill to mimic enzalutamide

    Drug: Leuprolide
    Other Names:
  • Eligard
  • Leuprolide Acetate
  • Leuprorelin
  • Lupron

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Metastasis-free survival (MFS) [Up to approximately 90 months]

      Compared between enzalutamide plus leuprolide and placebo plus leuprolide.

    Secondary Outcome Measures

    1. Overall survival [Up to approximately 132 months]

    2. Time to castration resistance [Up to approximately 90 months]

    3. Composite of safety [Up to approximately 90 months]

      Safety will be evaluated by the incidence of serious adverse events, incidence and severity of adverse events, incidence of permanent treatment discontinuation due to adverse events, and incidence of new clinically significant changes in clinical laboratory values and vital signs.

    4. Metastasis-free survival (MFS) [Up to approximately 90 months]

      Compared between enzalutamide monotherapy versus placebo plus leuprolide.

    5. Time to prostate specific antigen (PSA) progression; [Up to approximately 90 months]

    6. Time to first use of new antineoplastic therapy [Up to approximately 90 months]

    7. Time to distant metastasis [Up to approximately 90 months]

    8. Proportion of patients per group who remain treatment free 2 years after suspension of study drug treatment at week 37 due to undetectable PSA [From baseline (week 37) up to 90 months]

    9. Proportion of patients per group with undetectable PSA 2 years after suspension of study drug treatment at week 37 due to undetectable PSA [From baseline (week 37) up to 90 months]

    10. Proportion of patients per group with undetectable PSA at 36 weeks on study drug [At week 36]

    11. Time to resumption of any hormonal therapy following suspension at week 37 due to undetectable PSA [From baseline (week 37) up to 90 months]

    12. Time to symptomatic progression [Up to approximately 90 months]

    13. Time to first symptomatic skeletal event [Up to approximately 90 months]

    14. Time to clinically relevant pain [Up to approximately 90 months]

    15. Quality of life via the Functional Assessment of Cancer Therapy Prostate (FACT P) questionnaire, [Up to approximately 90 months]

    16. Quality of life via the European Quality of Life 5 Dimensions 5 Levels Health Questionnaire (EQ 5D 5L), [Up to approximately 90 months]

    17. Quality of life via the Quality of Life Questionnaire Prostate 25 (QLQ PR25) module [Up to approximately 90 months]

    Eligibility Criteria

    Criteria

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

    • Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features;

    • Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent;

    • PSA doubling time ≤ 9 months;

    • Screening PSA by the central laboratory ≥ 1 ng/mL for patients who had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and at least 2 ng/mL above the nadir for patients who had radiotherapy only as primary treatment for prostate cancer;

    • Serum testosterone ≥ 150 ng/dL (5.2 nmol/L).

    Exclusion Criteria:

    • Prior or present evidence of distant metastatic disease as assessed by radiographic imaging;

    • Prior hormonal therapy. Neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before randomization, or a single dose or a short course (≤ 6 months) of hormonal therapy given for rising PSA ≥ 9 months before randomization is allowed.;

    • Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer;

    • Prior systemic biologic therapy, including immunotherapy, for prostate cancer;

    • Major surgery within 4 weeks before randomization;

    • Treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks of randomization;

    • Known or suspected brain metastasis or active leptomeningeal disease;

    • History of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrence

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35233
    2 University of Alabama at Birmingham, IDS Pharmacy Birmingham Alabama United States 35249
    3 University of Alabama at Birmingham Birmingham Alabama United States 35249
    4 Alaska Urological Institute dba Alaska Clinical Research Center Anchorage Alaska United States 99503
    5 Urological Associates of Southern Arizona, PC Tucson Arizona United States 85741
    6 Tower Hematology Oncology Medical Group Beverly Hills California United States 90211
    7 Cedars-Senai OCC Pharmacy Los Angeles California United States 90048
    8 Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute Los Angeles California United States 90048
    9 University of California, Irvine Medical Center Orange California United States 92868
    10 Sutter Medical Group, Vascular & Varicose Vein Center Roseville California United States 95661
    11 Sutter Medical Group Roseville California United States 95661
    12 UC Davis Comprehensive Cancer Center Sacramento California United States 95817
    13 University of California Davis Medical Center Sacramento California United States 95817
    14 University of California, Davis, School of Medicine Sacramento California United States 95817
    15 The Urology Center of Colorado Denver Colorado United States 80211
    16 Foothills Urology, P.C. Golden Colorado United States 80401
    17 Eastern Connecticut Hematology Oncology Associates Norwich Connecticut United States 06360
    18 Johns Hopkins Kimmel Cancer Center/ Sibley Infusion Washington District of Columbia United States 20016
    19 Sibley Memorial Hospital Washington District of Columbia United States 20016
    20 Lakeland Regional Health Hollis Cancer Center Lakeland Florida United States 33805
    21 Emory University Hospital Atlanta Georgia United States 30322
    22 Investigational Drug Service Atlanta Georgia United States 30322
    23 The Emory Clinic Atlanta Georgia United States 30322
    24 Winship Cancer Institute, Emory University Atlanta Georgia United States 30322
    25 Northwestern Medical Group Chicago Illinois United States 60611
    26 Northwestern Memorial Hospital Chicago Illinois United States 60611
    27 First Urology, PSC Jeffersonville Indiana United States 47130
    28 The University of Kansas Hospital Kansas City Kansas United States 66160
    29 Kansas City Urology Care, PA Overland Park Kansas United States 66211-1231
    30 The University of Kansas Cancer Center and Medical Pavilion Westwood Kansas United States 66205
    31 The University of Kansas Cancer Center, Investigational Drug Services Westwood Kansas United States 66205
    32 GU Research Network/Wichita Urology Group Wichita Kansas United States 67226
    33 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231
    34 The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services Baltimore Maryland United States 21231
    35 John Hopkins University Hospital Baltimore Maryland United States 21287
    36 Chesapeake Urology Research Associates Towson Maryland United States 21204
    37 Comprehensive Urology - Macomb Office Macomb Michigan United States 48044
    38 Comprehensive Urology - Royal Oak (Stephenson) office Royal Oak Michigan United States 48067
    39 GU Research Network, LLC / Urology Cancer Center Omaha Nebraska United States 68130
    40 VA Lahontan Valley Outpatient Clinic Fallon Nevada United States 89406
    41 Memorial Sloan Kettering Cancer Center Basking Ridge Basking Ridge New Jersey United States 07920
    42 Memorial Sloan Kettering Cancer Center Commack Commack New York United States 11725
    43 Memorial Sloan Kettering Cancer Center Westchester Harrison New York United States 10604
    44 Memorial Hospital New York New York United States 10065
    45 Sidney Kimmel Center for Prostate and Urologic Cancers New York New York United States 10065
    46 Premier Medical Group of the Hudson Valley PC Poughkeepsie New York United States 12603
    47 Memorial Sloan Kettering Cancer Center Rockville Centre Rockville Centre New York United States 11570
    48 Associated Medical Professionals of New York, PLLC Syracuse New York United States 13210
    49 Memorial Sloan Kettering Cancer Center Nassau Uniondale New York United States 11553
    50 Duke Investigational Chemotherapy Services Durham North Carolina United States 27710
    51 Duke Nuclear Medicine Durham North Carolina United States 27710
    52 Duke University Medical Center Durham North Carolina United States 27710
    53 Alliance Urology Specialists, PA Greensboro North Carolina United States 27403
    54 TriState Urologic Services PSC Inc., dba The Urology Group Cincinnati Ohio United States 45212
    55 Mercy Health Jewish Hospital Cincinnati Ohio United States 45236
    56 Clinical Research Solutions Middleburg Heights Ohio United States 44130
    57 Southwest Urology Middleburg Heights Ohio United States 44130
    58 OU Medical Center Presbyterian Tower Oklahoma City Oklahoma United States 73104
    59 Stephenson Cancer Center Oklahoma City Oklahoma United States 73104
    60 Stephenson Cancer Center Oklahoma City Oklahoma United States 73140
    61 Oregon Imaging Center Eugene Oregon United States 97401
    62 Oregon Urology Institute Springfield Oregon United States 97477
    63 Urologic Consultants of SE PA Bala-Cynwyd Pennsylvania United States 19004
    64 Lancaster Urology Lancaster Pennsylvania United States 17604
    65 Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization Philadelphia Pennsylvania United States 19083
    66 Jefferson Medical Oncology Philadelphia Pennsylvania United States 19107
    67 Jefferson Urology Associates Philadelphia Pennsylvania United States 19107
    68 Thomas Jefferson University Hospital, Bodine Buiding Philadelphia Pennsylvania United States 19107
    69 Thomas Jefferson University, Sidney Kimmel Cancer Center Philadelphia Pennsylvania United States 19107
    70 Carolina Urologic Research Center Myrtle Beach South Carolina United States 29572
    71 Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery Nashville Tennessee United States 37232
    72 Vanderbilt Unversity Medical Center, The Urology Clinic Nashville Tennessee United States 37232
    73 Urology Clinics of North Texas, PLLC Dallas Texas United States 75231
    74 Houston Metro Urology Houston Texas United States 77027
    75 Urology San Antonio Research San Antonio Texas United States 78229
    76 Henrico Doctor's Hospital Henrico Virginia United States 23229
    77 Virginia Urology Richmond Virginia United States 23235
    78 Urology of Virginia, PLLC. Virginia Beach Virginia United States 23462
    79 Genesis Cancer Care NSW Gateshead New South Wales Australia 2290
    80 Lismore Base hospital Lismore New South Wales Australia 2480
    81 Liverpool Hospital Liverpool New South Wales Australia 2170
    82 Macquarie University North Ryde New South Wales Australia 2109
    83 Genesis Cancer Care North Sydney New South Wales Australia 2060
    84 Port Macquarie Base Hospital Port Macquarie New South Wales Australia 2444
    85 Northern Cancer Institute St Leonards New South Wales Australia 2065
    86 The Tweed Hospital Tweed Heads New South Wales Australia 2485
    87 Australian Clinical Trials Pty Ltd Wahroonga New South Wales Australia 2076
    88 Sydney Adventist Hospital Wahroonga New South Wales Australia 2076
    89 Calvary Mater Newcastle Waratah New South Wales Australia 2298
    90 Westmead Hospital Westmead New South Wales Australia 2145
    91 Illawarra Cancer Care Centre Wollongong New South Wales Australia 2500
    92 Crown Princess Mary Cancer Centre Westmead NEW Australia 2145
    93 Icon Cancer Care Wesley Auchenflower Queensland Australia 4066
    94 Icon Cancer Care Chermside Chermside Queensland Australia 4032
    95 Icon Cancer Care South Brisbane South Brisbane Queensland Australia 4101
    96 Icon Cancer Foundation South Brisbane Queensland Australia 4101
    97 Icon Cancer Centre Southport Southport Queensland Australia 4215
    98 Royal Adelaide Hospital Adelaide South Australia Australia 5000
    99 Box Hill Hospital Box Hill Victoria Australia 3128
    100 Monash Medical Centre Clayton Victoria Australia 3168
    101 Austin Health Heidelberg Victoria Australia 3084
    102 Australian Urology Associates Malvern Victoria Australia 3144
    103 Sunshine Hospital St Albans Victoria Australia 3021
    104 Fiona Stanley Hospital Murdoch Western Australia Australia 6150
    105 Hospital Barmherzige Schwestern Linz Linz Upper Austria Austria 4010
    106 Hospital Barmherzige Schwestern Linz, Department of Urology Linz Austria 4010
    107 Ordensklinikum Linz GmbH Linz Austria 4020
    108 Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Austria Salzburg Austria 5020
    109 Department of Radiology, University Hospital Salzburg, Austria Salzburg Austria 5020
    110 Department of Urology,Paracelsus Medical University Salzburg Salzburg Austria 5020
    111 AKH - Medizinische Universität Wien Vienna Austria 1090
    112 Department of Internal Medicine I, Medical university Vienna Vienna Austria 1090
    113 Hospital São Rafael S.A Salvador BA Brazil 41253-190
    114 Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner Curitiba Parana Brazil 81520-060
    115 CITO - Centro Integrado de Terapia Onco-Hematologica - Hospital de Clinicas de Passo Fundo Passo Fundo RS Brazil 99010-260
    116 Hospital de Clinicas de Porto Alegre Porto Alegre RS Brazil 90035-903
    117 CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda. Porto Alegre RS Brazil 90430-090
    118 Hospital Sao Lucas da PUCRS Porto Alegre RS Brazil 90610-0000
    119 Fundacao Pio XII - Hospital de Cancer de Barretos Barretos SP Brazil 14784-400
    120 Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP Campinas SP Brazil 13083-970
    121 Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC Santo Andre SP Brazil 09060-650
    122 Oncosite - Centro de Pesquisa Clinica em Oncologia Ltda Ijuí/RS Brazil 98700-000
    123 Prostate Cancer Centre Calgary Alberta Canada T2V 1P9
    124 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    125 Vancouver Prostate Centre Vancouver British Columbia Canada V5Z 1M9
    126 Manitoba Prostate Centre CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    127 Nova Scotia Health Authority Halifax Nova Scotia Canada B3H 2Y9
    128 The Male/Female Health and Research Centre, Royal Court Medical Centre Barrie Ontario Canada L4M 7G1
    129 Kingston General Hospital Kingston Ontario Canada K7L 2V7
    130 Centre for Applied Urological Research Kingston Ontario Canada K7L 3J7
    131 Hotel Dieu Hospital Kingston Ontario Canada K7L 5G2
    132 Urology Associates/ Urologic Medical Research Kitchener Ontario Canada N2N 2B9
    133 London Health Sciences Centre - Victoria Hospital London Ontario Canada N6A 5W9
    134 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5
    135 University Health Network - Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9
    136 Urology South Shore Research Greenfield Park Quebec Canada J4V 2H3
    137 Centre Hospitalier de l'Universite de Montreal Montreal Quebec Canada H2X 3E4
    138 McGill University Health Centre Montreal Quebec Canada H4A 3J1
    139 Ultra-Med Inc. Pointe-Claire Quebec Canada H9R 4S3
    140 CHU de Quebec - L'Hotel-Dieu de Quebec Quebec Canada G1R 2J6
    141 CHU de Quebec - L'Hotel-Dieu de Quebec - CRCEO Quebec Canada G1R 3S1
    142 Aarhus University Hospital Arhus N Denmark 8200
    143 Rigshospitalet - Copenhagen University Hospital Copenhagen N Denmark 2200
    144 Rigshospitalet - Copenhagen University Hospital Copenhagen Denmark 2100
    145 Rigshospitalet, Dept of Radiology Copenhagen Denmark 2100
    146 Odense University Hospital Odense C Denmark 5000
    147 Vejle Sygehus Vejle Denmark 7100
    148 Helsingin yliopistollinen keskussairaala Helsinki Finland 00290
    149 Oulun yliopistollinen sairaala Oulu Finland 90220
    150 Satakunnan Keskussairaala Pori Finland 28500
    151 Seinaejoen Keskussairaala Seinaejoki Finland 60220
    152 Tampereen yliopistollinen sairaala Tampere Finland 33520
    153 ICO- site Paul Papin Angers cedex 09 France 49933
    154 Clinique Pasteur - Lanroze Service Pharmacie Brest France 29200
    155 Clinique Pasteur - Lanroze Brest France 29200
    156 CHD Vendée LA ROCHE SUR YON cedex 9 France 85925
    157 CHRU de Lille - Hopital Claude Huriez Lille cedex France 59037
    158 ICM Val d'Aurelle Montpellier Cedex 5 France 34298
    159 ICM Val d'Aurelle Montpellier cedex France 34298
    160 CHU de Nantes - Hotel Dieu Nantes France 44000
    161 Hopital Saint-Louis Paris cedex 10 France 75475
    162 Institut Mutualiste Montsouris Paris Cedex 14 France 75674
    163 CHP Saint-Gregoire Saint-Gregoire France 35760
    164 ICO - site Rene Gauducheau Saint-Herblain cedex France 44805
    165 Hia Begin Saint-Mande France 94160
    166 Hopital Foch Suresnes France 92151
    167 Institut Gustave Roussy Villejuif cedex France 94805
    168 Institut Gustave Roussy Villejuif France 94800
    169 Farmacia, Azienda Socio Sanitaria Territoriale di Cremona Cremona Italy 26100
    170 Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona Cremona Italy 26100
    171 UO di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona Cremona Italy 26100
    172 UO di Oncologia,Ospedale Civile degli Infermi Faenza RA Italy 48018
    173 UO di Radiologia, Ospedale Civile degli Infermi Faenza RA Italy 48018
    174 UO di Oncologia, Ospedale Civile Umberto I Lugo RA Italy 48022
    175 Uo di Radiologia, Ospedale Civile Umberto I Lugo RA Italy 48022
    176 Laboratorio Farmaci Antiblastici, IRCCS Istituto Meldola (FC) Italy 47014
    177 U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola (FC) Italy 47014
    178 UO Radiologia,IRCCS Istituto Scientifico Romagnolo Per lO Studio e la Cura dei Tumori (IRST) Meldola (FC) Italy 47014
    179 Istituto Nazionale Tumori Fondazione G. Pascale/Oncologia Medica A Napoli Italy 80131
    180 Farmacia Ospedaliera, Padiglione specialita, A.O.U. San Luigi Gonzaga Orbassano (TO) Italy 10043
    181 S.C.D.U. Oncologia Medica, A.O.U. San Luigi Gonzaga Orbassano (TO) Italy 10043
    182 S.C.D.U. Radiodiagnostica, A.O.U. San Luigi Gonzaga Orbassano (TO) Italy 10043
    183 Servizio di Farmacia, Ospedale Santa Maria delle Croci Ravenna Italy 48121
    184 Servizio di Radiologia, Ospedale Santa Maria Delle Croci Ravenna Italy 48121
    185 UO di Oncologia Medica, Ospedale Santa Maria delle Croci Ravenna Italy 48121
    186 Farmacia Interna, Ospedale degli Infermi Rimini Italy 47923
    187 UO Oncologia, Ospedale degli Infermi Rimini Italy 47923
    188 U.O.C. Farmacia, Ospedale Forlanini Roma Italy 00151
    189 Azienda Ospedaliera S, Camillo Forlanini, UOC per il governo clinico in Oncologia Medica,pad,Flajani Roma Italy 00152
    190 U.O. di Oncologia Medica, Ospedale Santa Chiara Trento Italy 38122
    191 U.O. Farmacia, Ospedale Santa Chiara Trento Italy 38122
    192 U.O. Medicina Nucleare, Ospedale Santa Chiara Trento Italy 38122
    193 U.O. Radiologia, Ospedale Santa Chiara Trento Italy 38122
    194 Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Korea, Republic of 13620
    195 Pusan National University Yangsan Hospital Yangsan-si Gyeongsangnam-do Korea, Republic of 50612
    196 Chonnam National University Hwasun Hospital Hwasun-gun Jeollanam-do Korea, Republic of 58128
    197 Gachon University Gil Medical Center Incheon Korea, Republic of 21565
    198 Severance Hospital. Yonsei University Health System Seoul Korea, Republic of 03722
    199 Asan Medical Center Seoul Korea, Republic of 05505
    200 Gangnam Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 06273
    201 Samsung Medical Center Seoul Korea, Republic of 06351
    202 VU Medical Centrum, Department of Urology Amsterdam Netherlands 1081 HV
    203 Academisch Medisch Centrum Amsterdam Netherlands 1105AZ
    204 Gelderse Vallei Ziekenhuis Ede Netherlands 6710 HN
    205 Catharina Ziekenhuis Eindhoven Eindhoven Netherlands 5623 EJ
    206 University Medical Centrum Groningen, Department Urologie Groningen Netherlands 9713 GZ
    207 Medisch Centrum Leeuwarden Leeuwarden Netherlands 8934 AD
    208 Maastricht University Medical Center, Department of Urology Maastricht Netherlands 6229 HX
    209 Antonius Ziekenhuis Sneek Netherlands 8601 ZK
    210 Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii Gdansk Poland 80-952
    211 Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o. o. Slupsk Poland 76-200
    212 Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Urologiczny Slupsk Poland 76-200
    213 Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o Torun Poland 87-100
    214 Centrum Medyczne Melita Medical Wroclaw Poland 50-449
    215 EMC Instytut Medyczny Spolka Akcyjna Wroclaw Poland 54-144
    216 Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica Slovakia 975 17
    217 CUIMED, s.r.o., Urologicka ambulancia Bratislava Slovakia 851 05
    218 Vychodoslovensky onkologicky ustav, a.s. Kosice Slovakia 041 91
    219 Univerzitna nemocnica Martin Martin Slovakia 036 59
    220 UROEXAM, spol. s r.o. Nitra Slovakia 949 01
    221 MILAB Presov Slovakia 080 81
    222 Fakultna nemocnica s poliklinikou Zilina Zilina Slovakia 012 07
    223 Hospital Universitari Son Espases Palma de Mallorca Islas Baleares Spain 07010
    224 Complejo Hospitalario Universitario de Santiago Santiago de Compostela LA Coruna Spain 15706
    225 Hospital del Mar Barcelona Spain 08003
    226 Hospital Clinic i Provincial de Barcelona, Dr. Antonio Alcaraz Asensio Barcelona Spain 08036
    227 Hospital Universitario Puerta del Mar Cadiz Spain 11009
    228 ICO Girona; Hospital Universitari de Girona Dr. Josep Trueta. Servicio de Oncologia Girona Spain 17007
    229 Hospital Universitario de La Princesa Madrid Spain 28006
    230 Hospital General Universitario Gregorio Maranon. Servicio de Oncologia. Madrid Spain 28007
    231 Centro Oncologico MD Anderson International Espana Madrid Spain 28033
    232 Hospital Universitario Ramon Y Cajal Madrid Spain 28034
    233 Hospital Universitario 12 de Octubre Madrid Spain 28041
    234 Althaia, Xarxa Assistencial Universitària de Manresa Manresa Spain 08243
    235 Complejo Hospitalario Universitario de Orense Orense Spain 32005
    236 Corporacio Sanitaria Parc Tauli Sabadell Spain 08208
    237 Hospital Clinico Universitario de Salamanca Salamanca Spain 37007
    238 Instituto Valenciano de Oncologia IVO Valencia Spain 46009
    239 Sahlgrenska Universitetssjukhuset, Sahlgrenska Goteborg Sweden 413 45
    240 Skanes Universitetssjukhus Malmo Sweden 205 02
    241 Universitetssjukhuset Orebro Orebro Sweden 70 185
    242 Sodersjukhuset AB Stockholm Sweden 118 83
    243 Karolinska Universitetssjukhuset Solna Stockholm Sweden 17176
    244 Norrlands Universitetssjukhus Umea Sweden 90 185
    245 Norrlands Universitetssjukhus Umea Sweden 90185
    246 Akademiska Sjukhuset Uppsala Sweden 751 85
    247 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 807
    248 China Medical University Hospital Taichung Taiwan 40447
    249 Taichung Veterans General Hospital Taichung Taiwan 40705
    250 National Taiwan University Hospital Taipei Taiwan 10002
    251 Chang Gung Memorial Hospital, Linkou Taoyuan Taiwan 333
    252 Ross Hall Hospital Glasgow CITY OF Glasgow United Kingdom G52 3NQ
    253 Royal Devon & Exeter Hospital Wonford, Exeter Devon United Kingdom EX2 5DW
    254 Royal Free Hospital London Greater London United Kingdom NW3 2QG
    255 The Royal Marsden NHS Foundation Trust Sutton Surrey United Kingdom SM2 5PT
    256 Cancer Centre, Queen Elizabeth Hospital Birmingham WEST Midlands United Kingdom B15 2TH
    257 University Hospitals Bristol NHS Foundation Trust Bristol United Kingdom BS2 8ED
    258 Beatson West of Scotland Cancer Centre Glasgow United Kingdom G12 OYN

    Sponsors and Collaborators

    • Pfizer
    • Astellas Pharma Inc
    • Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

    Investigators

    • Study Director: Pfizer Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT02319837
    Other Study ID Numbers:
    • MDV3100-13
    • C3431004
    • 2014-001634-28
    First Posted:
    Dec 18, 2014
    Last Update Posted:
    May 31, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Leuprolide

    Study Results

    No Results Posted as of May 31, 2022