Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02319837
Recruitment Status : Active, not recruiting
First Posted : December 18, 2014
Last Update Posted : July 31, 2019
Sponsor:
Collaborators:
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Information provided by (Responsible Party):
Pfizer

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
Hormone Sensitive Prostate Cancer Prostate Cancer Cancer of the Prostate Drug: Enzalutamide Drug: Placebo Drug: Leuprolide Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : December 17, 2014
Estimated Primary Completion Date : July 7, 2020
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. Metastasis-free survival (MFS) [ Time Frame: Up to approximatey 67 months ]
    Compared between enzalutamide plus leuprolide and placebo plus leuprolide.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to approximately 96 months ]
  2. Time to castration resistance [ Time Frame: Up to approximately 67 months ]
  3. Composite of safety [ Time Frame: Up to approximately 67 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) [ Time Frame: Up to approximately 67 months ]
    Compared between enzalutamide monotherapy versus placebo plus leuprolide.

  5. Time to prostate specific antigen (PSA) progression; [ Time Frame: Up to approximately 67 months ]
  6. Time to first use of new antineoplastic therapy [ Time Frame: Up to approximately 67 months ]
  7. Time to distant metastasis [ Time Frame: Up to approximately 67 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 [ Time Frame: From baseline (week 37) up to 67 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 [ Time Frame: From baseline (week 37) up to 67 months ]
  10. Proportion of patients per group with undetectable PSA at 36 weeks on study drug [ Time Frame: At week 36 ]
  11. Time to resumption of any hormonal therapy following suspension at week 37 due to undetectable PSA [ Time Frame: From baseline (week 37) up to 67 months ]
  12. Time to symptomatic progression [ Time Frame: Up to approximately 67 months ]
  13. Time to first symptomatic skeletal event [ Time Frame: Up to approximately 96 months ]
  14. Time to clinically relevant pain [ Time Frame: Up to approximately 67 months ]
  15. Quality of life via the Functional Assessment of Cancer Therapy Prostate (FACT P) questionnaire, [ Time Frame: Up to approximately 67 months ]
  16. Quality of life via the European Quality of Life 5 Dimensions 5 Levels Health Questionnaire (EQ 5D 5L), [ Time Frame: Up to approximately 67 months ]
  17. Quality of life via the Quality of Life Questionnaire Prostate 25 (QLQ PR25) module [ Time Frame: Up to approximately 67 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319837


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, United States, 35249
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, Alaska
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, United States, 99503
United States, Arizona
Urological Associates of Southern Arizona, PC
Tucson, Arizona, United States, 85741
United States, California
Tower Hematology Oncology Medical Group
Beverly Hills, California, United States, 90211
Cedars-Senai OCC Pharmacy
Los Angeles, California, United States, 90048
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sutter Medical Group
Roseville, California, United States, 95661
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
University of California Davis Medical Center
Sacramento, California, United States, 95817
University of California, Davis, School of Medicine
Sacramento, California, United States, 95817
United States, Colorado
The Urology Center of Colorado
Denver, Colorado, United States, 80211
Foothills Urology, P.C.
Golden, Colorado, United States, 80401
United States, Connecticut
Eastern Connecticut Hematology Oncology Associates
Norwich, Connecticut, United States, 06360
United States, District of Columbia
Johns Hopkins Kimmel Cancer Center/ Sibley Infusion
Washington, District of Columbia, United States, 20016
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
Lakeland Regional Health Hollis Cancer Center
Lakeland, Florida, United States, 33805
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Investigational Drug Service
Atlanta, Georgia, United States, 30322
The Emory Clinic
Atlanta, Georgia, United States, 30322
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern Medical Group
Chicago, Illinois, United States, 60611
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Indiana
First Urology, PSC
Jeffersonville, Indiana, United States, 47130
United States, Kansas
The University of Kansas Hospital
Kansas City, Kansas, United States, 66160
Kansas City Urology Care, PA
Overland Park, Kansas, United States, 66211-1231
The University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, United States, 66205
The University of Kansas Cancer Center, Investigational Drug Services
Westwood, Kansas, United States, 66205
GU Research Network/Wichita Urology Group
Wichita, Kansas, United States, 67226
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services
Baltimore, Maryland, United States, 21231
John Hopkins University Hospital
Baltimore, Maryland, United States, 21287
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
United States, Michigan
Comprehensive Urology - Macomb Office
Macomb, Michigan, United States, 48044
Comprehensive Urology - Royal Oak (Stephenson) office
Royal Oak, Michigan, United States, 48067
United States, Nebraska
GU Research Network, LLC / Urology Cancer Center
Omaha, Nebraska, United States, 68130
United States, Nevada
VA Lahontan Valley Outpatient Clinic
Fallon, Nevada, United States, 89406
United States, New Jersey
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey, United States, 07920
United States, New York
Memorial Sloan Kettering Cancer Center Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center Westchester
Harrison, New York, United States, 10604
Memorial Hospital
New York, New York, United States, 10065
Sidney Kimmel Center for Prostate and Urologic Cancers
New York, New York, United States, 10065
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, United States, 12601
Memorial Sloan Kettering Cancer Center Rockville Centre
Rockville Centre, New York, United States, 11570
Associated Medical Professionals of New York, PLLC
Syracuse, New York, United States, 13210
Memorial Sloan Kettering Cancer Center Nassau
Uniondale, New York, United States, 11553
United States, North Carolina
Duke Investigational Chemotherapy Services
Durham, North Carolina, United States, 27710
Duke Nuclear Medicine
Durham, North Carolina, United States, 27710
Duke University Medical Center
Durham, North Carolina, United States, 27710
Alliance Urology Specialists, PA
Greensboro, North Carolina, United States, 27403
United States, Ohio
TriState Urologic Services PSC Inc., dba The Urology Group
Cincinnati, Ohio, United States, 45212
Mercy Health Jewish Hospital
Cincinnati, Ohio, United States, 45236
Clinical Research Solutions
Middleburg Heights, Ohio, United States, 44130
Southwest Urology
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
OU Medical Center Presbyterian Tower
Oklahoma City, Oklahoma, United States, 73104
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73140
United States, Oregon
Oregon Urology Institute
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, United States, 19004
Lancaster Urology
Lancaster, Pennsylvania, United States, 17604
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Philadelphia, Pennsylvania, United States, 19083
Jefferson Medical Oncology
Philadelphia, Pennsylvania, United States, 19107
Jefferson Urology Associates
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University Hospital, Bodine Buiding
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery
Nashville, Tennessee, United States, 37232
Vanderbilt Unversity Medical Center, The Urology Clinic
Nashville, Tennessee, United States, 37232
United States, Texas
Urology Clinics of North Texas, PLLC
Dallas, Texas, United States, 75231
Houston Metro Urology
Houston, Texas, United States, 77027
Urology San Antonio Research
San Antonio, Texas, United States, 78229
United States, Virginia
Henrico Doctor's Hospital
Henrico, Virginia, United States, 23229
Virginia Urology
Richmond, Virginia, United States, 23230
Virginia Urology
Richmond, Virginia, United States, 23235
Urology of Virginia, PLLC.
Virginia Beach, Virginia, United States, 23462
Australia, New South Wales
Genesis Cancer Care NSW
Gateshead, New South Wales, Australia, 2290
Lismore Base hospital
Lismore, New South Wales, Australia, 2480
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Macquarie University
North Ryde, New South Wales, Australia, 2109
Genesis Cancer Care
North Sydney, New South Wales, Australia, 2060
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia, 2444
Northern Cancer Institute
St Leonards, New South Wales, Australia, 2065
The Tweed Hospital
Tweed Heads, New South Wales, Australia, 2485
Australian Clinical Trials Pty Ltd
Wahroonga, New South Wales, Australia, 2076
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia, 2076
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Illawarra Cancer Care Centre
Wollongong, New South Wales, Australia, 2500
Australia, NEW
Crown Princess Mary Cancer Centre
Westmead, NEW, Australia, 2145
Australia, Queensland
Icon Cancer Care Wesley
Auchenflower, Queensland, Australia, 4066
Icon Cancer Care Chermside
Chermside, Queensland, Australia, 4032
Icon Cancer Care South Brisbane
South Brisbane, Queensland, Australia, 4101
Icon Cancer Foundation
South Brisbane, Queensland, Australia, 4101
Icon Cancer Centre Southport
Southport, Queensland, Australia, 4215
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Austin Health
Heidelberg, Victoria, Australia, 3084
Australian Urology Associates
Malvern, Victoria, Australia, 3144
Sunshine Hospital
St Albans, Victoria, Australia, 3021
Australia, Western Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Austria
Hospital Barmherzige Schwestern Linz
Linz, Upper Austria, Austria, 4010
Hospital Barmherzige Schwestern Linz, Department of Urology
Linz, Austria, 4010
Ordensklinikum Linz GmbH
Linz, Austria, 4020
Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Austria
Salzburg, Austria, 5020
Department of Radiology, University Hospital Salzburg, Austria
Salzburg, Austria, 5020
Department of Urology,Paracelsus Medical University Salzburg
Salzburg, Austria, 5020
AKH - Medizinische Universität Wien
Vienna, Austria, 1090
Department of Internal Medicine I, Medical university Vienna
Vienna, Austria, 1090
Brazil
Monte Tabor Centro Italo Brasileiro de Promocao Sanitaria - Hospital Sao Rafael
Salvador, BA, Brazil, 41253-190
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
Curitiba, PR, Brazil, 81520-060
Associacao Hospital de Caridade Ijui
Ijui, RS, Brazil, 98700-000
CITO - Centro Integrado de Terapia Onco-Hematologica - Hospital da Cidade de Passo Fundo
Passo Fundo, RS, Brazil, 99010-260
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-903
CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.
Porto Alegre, RS, Brazil, 90430-090
Hospital Sao Lucas da PUCRS
Porto Alegre, RS, Brazil, 90610-000
Fundacao Pio XII - Hospital de Cancer de Barretos
Barretos, SP, Brazil, 14784-400
Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP
Campinas, SP, Brazil, 13083-970
Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
Santo Andre, SP, Brazil, 09051-040
Canada, Alberta
Prostate Cancer Centre
Calgary, Alberta, Canada, T2V 1P9
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Vancouver Prostate Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Manitoba Prostate Centre CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
Nova Scotia Heath Authority, Central
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
The Male/Female Health and Research Centre, Royal Court Medical Centre
Barrie, Ontario, Canada, L4M 7G1
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Centre for Applied Urological Research
Kingston, Ontario, Canada, K7L 3J7
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Urology Associates/ Urologic Medical Research
Kitchener, Ontario, Canada, N2N 2B9
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada, N6A 5W9
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Urology South Shore Research
Greenfield Park, Quebec, Canada, J4V 2H3
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 3E4
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Ultra-Med Inc.
Pointe-Claire, Quebec, Canada, H9R 4S3
Canada
CHU de Quebec - L'Hotel-Dieu de Quebec
Quebec, Canada, G1R 2J6
CHU de Quebec - L'Hotel-Dieu de Quebec - CRCEO
Quebec, Canada, G1R 3S1
Denmark
Aarhus University Hospital
Arhus N, Denmark, 8200
Rigshospitalet - Copenhagen University Hospital
Copenhagen N, Denmark, 2200
Rigshospitalet - Copenhagen University Hospital
Copenhagen, Denmark, 2100
Rigshospitalet, Dept of Radiology
Copenhagen, Denmark, 2100
Odense University Hospital
Odense C, Denmark, 5000
Vejle Sygehus
Vejle, Denmark, 7100
Finland
Helsingin yliopistollinen keskussairaala
Helsinki, Finland, 00290
Oulun yliopistollinen sairaala
Oulu, Finland, 90220
Satakunnan Keskussairaala
Pori, Finland, 28500
Seinaejoen Keskussairaala
Seinaejoki, Finland, 60220
Tampereen yliopistollinen sairaala
Tampere, Finland, 33520
France
ICO- site Paul Papin
Angers cedex 09, France, 49933
Clinique Pasteur - Lanroze Service Pharmacie
Brest, France, 29200
Clinique Pasteur - Lanroze
Brest, France, 29200
CHD Vendee
La Roche-sur-Yon, France, 85925
CHRU de Lille - Hopital Claude Huriez
Lille cedex, France, 59037
ICM Val d'Aurelle
Montpellier cedex, France, 34298
CHU de Nantes - Hotel Dieu
Nantes, France, 44000
Hopital Saint-Louis
Paris cedex 10, France, 75475
Institut Mutualiste Montsouris
Paris Cedex 14, France, 75674
CHP Saint-Gregoire
Saint-Gregoire, France, 35760
ICO - site Rene Gauducheau
Saint-Herblain cedex, France, 44805
Hia Begin
Saint-Mande, France, 94160
Hopital Foch
Suresnes, France, 92151
Institut Gustave Roussy
Villejuif cedex, France, 94805
Institut Gustave Roussy
Villejuif, France, 94800
Italy
Farmacia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, Italy, 26100
Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, Italy, 26100
UO di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, Italy, 26100
UO di Oncologia,Ospedale Civile degli Infermi
Faenza RA, Italy, 48018
UO di Radiologia, Ospedale Civile degli Infermi
Faenza RA, Italy, 48018
UO di Oncologia, Ospedale Civile Umberto I
Lugo RA, Italy, 48022
Uo di Radiologia, Ospedale Civile Umberto I
Lugo RA, Italy, 48022
Laboratorio Farmaci Antiblastici, IRCCS Istituto
Meldola (FC), Italy, 47014
U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola (FC), Italy, 47014
UO Radiologia,IRCCS Istituto Scientifico Romagnolo Per lO Studio e la Cura dei Tumori (IRST)
Meldola (FC), Italy, 47014
Istituto Nazionale Tumori Fondazione G. Pascale/Oncologia Medica A
Napoli, Italy, 80131
Farmacia Ospedaliera, Padiglione specialita, A.O.U. San Luigi Gonzaga
Orbassano (TO), Italy, 10043
S.C.D.U. Oncologia Medica, A.O.U. San Luigi Gonzaga
Orbassano (TO), Italy, 10043
S.C.D.U. Radiodiagnostica, A.O.U. San Luigi Gonzaga
Orbassano (TO), Italy, 10043
Servizio di Farmacia, Ospedale Santa Maria delle Croci
Ravenna, Italy, 48121
Servizio di Radiologia, Ospedale Santa Maria Delle Croci
Ravenna, Italy, 48121
UO di Oncologia Medica, Ospedale Santa Maria delle Croci
Ravenna, Italy, 48121
Farmacia Interna, Ospedale degli Infermi
Rimini, Italy, 47923
UO Oncologia, Ospedale degli Infermi
Rimini, Italy, 47923
U.O.C. Farmacia, Ospedale Forlanini
Roma, Italy, 00151
Azienda Ospedaliera S, Camillo Forlanini, UOC per il governo clinico in Oncologia Medica,pad,Flajani
Roma, Italy, 00152
Ospedale San Camillo Forlanini
Roma, Italy, 00152
U.O. di Oncologia Medica, Ospedale Santa Chiara
Trento, Italy, 38122
U.O. Farmacia, Ospedale Santa Chiara
Trento, Italy, 38122
U.O. Medicina Nucleare, Ospedale Santa Chiara
Trento, Italy, 38122
U.O. Radiologia, Ospedale Santa Chiara
Trento, Italy, 38122
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Pusan National University Yangsan Hospital
Yangsan-si, Gyeongsangnam-do, Korea, Republic of, 50612
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, Korea, Republic of, 58128
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 21565
Severance Hospital. Yonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center
Seoul, Korea, Republic of, 05505
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 06273
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Netherlands
VU Medical Centrum, Department of Urology
Amsterdam, Netherlands, 1081 HV
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105AZ
Gelderse Vallei Ziekenhuis
Ede, Netherlands, 6710 HN
Catharina Ziekenhuis Eindhoven
Eindhoven, Netherlands, 5623 EJ
University Medical Centrum Groningen, Department Urologie
Groningen, Netherlands, 9713 GZ
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands, 8934 AD
Maastricht University Medical Center, Department of Urology
Maastricht, Netherlands, 6229 HX
Antonius Ziekenhuis
Sneek, Netherlands, 8601 ZK
Poland
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
Gdansk, Poland, 80-952
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o. o.
Slupsk, Poland, 76-200
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Urologiczny
Slupsk, Poland, 76-200
Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o
Torun, Poland, 87-100
Centrum Medyczne Melita Medical
Wroclaw, Poland, 50-449
EMC Instytut Medyczny Spolka Akcyjna
Wroclaw, Poland, 54-144
Slovakia
Fakultna nemocnica s poliklinikou F.D.Roosevelta
Banska Bystrica, Slovakia, 975 17
CUIMED, s.r.o., Urologicka ambulancia
Bratislava, Slovakia, 851 05
Vychodoslovensky onkologicky ustav, a.s.
Kosice, Slovakia, 041 91
Univerzitna nemocnica Martin
Martin, Slovakia, 036 59
UROEXAM, spol. s r.o.
Nitra, Slovakia, 949 01
MILAB
Presov, Slovakia, 080 81
Fakultna nemocnica s poliklinikou Zilina
Zilina, Slovakia, 012 07
Spain
Dr. Maria Aranzazu Gonzalez del Alba
Plama De Mallorca, Baleares, Spain, 07010
Dr. Montserrat Domenech Santasusana ALTHAIA, Xarxa assist. Univ. de Manresa - H. San Joan de Deu
Manresa, Barcelona, Spain, 08243
Dr. Jesus Munoz, Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain, 08208
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, LA Coruna, Spain, 15706
Hospital del Mar
Barcelona, Spain, 08003
Dr. Antonio Alcaraz Asensio, Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Universitario Puerta del Mar
Cadiz, Spain, 11009
ICO Girona; Hospital Universitari de Girona Dr. Josep Trueta. Servicio de Oncologia
Girona, Spain, 17007
Dr. Almudena Zapatero Laborda
Madrid, Spain, 28006
Hospital General Universitario Gregorio Maranon. Servicio de Oncologia.
Madrid, Spain, 28007
Centro Oncologico MD Anderson International Espana
Madrid, Spain, 28033
Dr. Francisco Javier Burgos Revilla
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Complejo Hospitalario Universitario de Orense
Orense, Spain, 32005
Hospital Clinico Universitario de Salamanca
Salamanca, Spain, 37007
Instituto Valenciano de Oncologia IVO
Valencia, Spain, 46009
Sweden
Sahlgrenska Universitetssjukhuset, Sahlgrenska
Goteborg, Sweden, 413 45
Skanes Universitetssjukhus
Malmo, Sweden, 205 02
Universitetssjukhuset Orebro
Orebro, Sweden, 70 185
Sodersjukhuset AB
Stockholm, Sweden, 118 83
Karolinska Universitetssjukhuset Solna
Stockholm, Sweden, 17176
Norrlands Universitetssjukhus
Umea, Sweden, 90 185
Norrlands Universitetssjukhus
Umea, Sweden, 90185
Akademiska Sjukhuset
Uppsala, Sweden, 751 85
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
China Medical University Hospital
Taichung, Taiwan, 40447
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
National Taiwan University Hospital
Taipei, Taiwan, 10002
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan, 333
United Kingdom
Ross Hall Hospital
Glasgow, CITY OF Glasgow, United Kingdom, G52 3NQ
Royal Devon & Exeter Hospital
Wonford, Exeter, Devon, United Kingdom, EX2 5DW
Royal Free Hospital
London, Greater London, United Kingdom, NW3 1QG
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Cancer Centre, Queen Elizabeth Hospital
Birmingham, WEST Midlands, United Kingdom, B15 2TH
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom, BS2 8ED
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
Layout table for investigator information
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer

Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02319837     History of Changes
Other Study ID Numbers: MDV3100-13
C3431004 ( Other Identifier: Alias Study Number )
2014-001634-28 ( EudraCT Number )
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents