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

Primary Purpose

Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Enzalutamide
Placebo (No longer applicable in Open Label study period)
Leuprolide Open Label
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hormone Sensitive Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • University of Alabama at Birmingham, IDS Pharmacy
  • University of Alabama at Birmingham
  • Alaska Urological Institute dba Alaska Clinical Research Center
  • Urological Associates of Southern Arizona, PC
  • Tower Hematology Oncology Medical Group
  • Cedars-Senai OCC Pharmacy
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
  • University of California, Irvine Medical Center
  • Sutter Medical Group, Vascular & Varicose Vein Center
  • Sutter Medical Group
  • UC Davis Comprehensive Cancer Center
  • University of California Davis Medical Center
  • University of California, Davis, School of Medicine
  • The Urology Center of Colorado
  • Foothills Urology, P.C.
  • Eastern Connecticut Hematology Oncology Associates
  • Johns Hopkins Kimmel Cancer Center/ Sibley Infusion
  • Lakeland Regional Health Hollis Cancer Center
  • Emory University Hospital
  • Investigational Drug Service
  • The Emory Clinic
  • Winship Cancer Institute, Emory University
  • Northwestern Medical Group
  • Northwestern Memorial Hospital
  • First Urology, PSC
  • The University of Kansas Hospital
  • Kansas City Urology Care, PA
  • The University of Kansas Cancer Center and Medical Pavilion
  • The University of Kansas Cancer Center, Investigational Drug Services
  • GU Research Network/Wichita Urology Group
  • John Hopkins University Hospital
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services
  • Chesapeake Urology Research Associates
  • Comprehensive Urology - Macomb Office
  • Comprehensive Urology - Royal Oak (Stephenson) office
  • GU Research Network, LLC / Urology Cancer Center
  • VA Lahontan Valley Outpatient Clinic
  • Memorial Sloan Kettering Cancer Center Basking Ridge
  • Memorial Sloan Kettering Cancer Center Commack
  • Memorial Sloan Kettering Cancer Center Westchester
  • Memorial Hospital
  • Sidney Kimmel Center for Prostate and Urologic Cancers
  • Premier Medical Group of the Hudson Valley PC
  • Memorial Sloan Kettering Cancer Center Rockville Centre
  • Associated Medical Professionals of New York, PLLC
  • Memorial Sloan Kettering Cancer Center Nassau
  • Duke Investigational Chemotherapy Services
  • Duke Nuclear Medicine
  • Duke University Medical Center
  • Alliance Urology Specialists, PA
  • TriState Urologic Services PSC Inc., dba The Urology Group
  • Mercy Health Jewish Hospital
  • Clinical Research Solutions
  • Southwest Urology
  • OU Medical Center Presbyterian Tower
  • Stephenson Cancer Center
  • Stephenson Cancer Center
  • Oregon Imaging Center
  • Oregon Urology Institute
  • Urologic Consultants of SE PA
  • Keystone Urology Specialists
  • Lancaster Urology
  • Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
  • Jefferson Medical Oncology
  • Jefferson Urology Associates
  • Thomas Jefferson University Hospital, Bodine Buiding
  • Thomas Jefferson University, Medical Oncology
  • Thomas Jefferson University, Sidney Kimmel Cancer Center
  • Carolina Urologic Research Center
  • Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery
  • Vanderbilt Unversity Medical Center, The Urology Clinic
  • Urology Clinics of North Texas, PLLC
  • Houston Metro Urology
  • Urology San Antonio Research
  • Henrico Doctor's Hospital
  • Virginia Urology
  • Urology of Virginia, PLLC.
  • Genesis Cancer Care NSW
  • Lismore Base hospital
  • Liverpool Hospital
  • Macquarie University
  • Genesis Cancer Care
  • Port Macquarie Base Hospital
  • GenesisCare North Shore
  • The Tweed Hospital
  • Australian Clinical Trials Pty Ltd
  • Sydney Adventist Hospital
  • Calvary Mater Newcastle
  • Westmead Hospital
  • Illawarra Cancer Care Centre
  • Crown Princess Mary Cancer Centre
  • Icon Cancer Care Wesley
  • Icon Cancer Care Chermside
  • Icon Cancer Care South Brisbane
  • Icon Cancer Foundation
  • Icon Cancer Centre Southport
  • Royal Adelaide Hospital
  • Box Hill Hospital
  • Monash Medical Centre
  • Austin Health
  • Australian Urology Associates
  • Sunshine Hospital
  • Fiona Stanley Hospital
  • Hospital Barmherzige Schwestern Linz
  • Hospital Barmherzige Schwestern Linz, Department of Urology
  • Ordensklinikum Linz GmbH
  • Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Austria
  • Department of Radiology, University Hospital Salzburg, Austria
  • Department of Urology,Paracelsus Medical University Salzburg
  • AKH - Medizinische Universität Wien
  • Department of Internal Medicine I, Medical university Vienna
  • Hospital São Rafael S.A
  • Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
  • CITO - Centro Integrado de Terapia Onco-Hematologica - Hospital de Clinicas de Passo Fundo
  • Hospital de Clinicas de Porto Alegre
  • CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.
  • Hospital Sao Lucas da PUCRS
  • Fundacao Pio XII - Hospital de Cancer de Barretos
  • Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP
  • Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
  • Oncosite - Centro de Pesquisa Clinica em Oncologia Ltda
  • Prostate Cancer Centre
  • Cross Cancer Institute
  • Vancouver Prostate Centre
  • Manitoba Prostate Centre CancerCare Manitoba
  • Nova Scotia Health Authority
  • The Male/Female Health and Research Centre, Royal Court Medical Centre
  • Kingston General Hospital
  • Centre for Applied Urological Research
  • Hotel Dieu Hospital
  • Urology Associates/ Urologic Medical Research
  • London Health Sciences Centre - Victoria Hospital
  • Sunnybrook Health Sciences Centre
  • University Health Network - Princess Margaret Cancer Centre
  • Urology South Shore Research
  • Centre Hospitalier de l'Universite de Montreal
  • McGill University Health Centre
  • Ultra-Med Inc.
  • CHU de Quebec - L'Hotel-Dieu de Quebec
  • CHU de Quebec - L'Hotel-Dieu de Quebec - CRCEO
  • Aarhus University Hospital
  • Rigshospitalet - Copenhagen University Hospital
  • Rigshospitalet - Copenhagen University Hospital
  • Rigshospitalet, Dept of Radiology
  • Odense University Hospital
  • Vejle Sygehus
  • Helsingin yliopistollinen keskussairaala
  • Oulun yliopistollinen sairaala
  • Satakunnan Keskussairaala
  • Seinaejoen Keskussairaala
  • Tampereen yliopistollinen sairaala
  • ICO- site Paul Papin
  • Clinique Pasteur - Lanroze Service Pharmacie
  • Clinique Pasteur - Lanroze
  • CHD Vendée
  • CHRU de Lille - Hopital Claude Huriez
  • ICM Val d'Aurelle
  • CHU de Nantes - Hotel Dieu
  • Hopital Saint-Louis
  • Institut Mutualiste Montsouris
  • CHP Saint-Gregoire
  • ICO - site Rene Gauducheau
  • Hia Begin
  • Hopital Foch
  • Institut Gustave Roussy
  • Institut Gustave Roussy
  • Farmacia, Azienda Socio Sanitaria Territoriale di Cremona
  • Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
  • UO di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona
  • UO di Oncologia,Ospedale Civile degli Infermi
  • UO di Radiologia, Ospedale Civile degli Infermi
  • UO di Oncologia, Ospedale Civile Umberto I
  • Uo di Radiologia, Ospedale Civile Umberto I
  • Laboratorio Farmaci Antiblastici, IRCCS Istituto
  • U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • UO Radiologia,IRCCS Istituto Scientifico Romagnolo Per lO Studio e la Cura dei Tumori (IRST)
  • Istituto Nazionale Tumori Fondazione G. Pascale/Oncologia Medica A
  • S.C.D.U. Oncologia Medica, A.O.U. San Luigi Gonzaga
  • S.C.D.U. Radiodiagnostica, A.O.U. San Luigi Gonzaga
  • Servizio di Farmacia, Ospedale Santa Maria delle Croci
  • Servizio di Radiologia, Ospedale Santa Maria Delle Croci
  • UO di Oncologia Medica, Ospedale Santa Maria delle Croci
  • Farmacia Interna, Ospedale degli Infermi
  • UO Oncologia, Ospedale degli Infermi
  • Azienda Ospedaliera S, Camillo Forlanini, UOC per il governo clinico in Oncologia Medica,pad,Flajani
  • U.O. di Oncologia Medica, Ospedale Santa Chiara
  • U.O. Medicina Nucleare, Ospedale Santa Chiara
  • U.O. Radiologia, Ospedale Santa Chiara
  • Seoul National University Bundang Hospital
  • Pusan National University Yangsan Hospital
  • Chonnam National University Hwasun Hospital
  • Gachon University Gil Medical Center
  • Severance Hospital. Yonsei University Health System
  • Asan Medical Center
  • Gangnam Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • VU Medical Centrum, Department of Urology
  • Academisch Medisch Centrum
  • Gelderse Vallei Ziekenhuis
  • Catharina Ziekenhuis Eindhoven
  • University Medical Centrum Groningen, Department Urologie
  • Medisch Centrum Leeuwarden
  • Maastricht University Medical Center, Department of Urology
  • Antonius Ziekenhuis
  • Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o. o.
  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Urologiczny
  • Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o
  • Centrum Medyczne Melita Medical
  • EMC Instytut Medyczny Spolka Akcyjna
  • Fakultna nemocnica s poliklinikou F.D.Roosevelta
  • CUIMED, s.r.o., Urologicka ambulancia
  • Vychodoslovensky onkologicky ustav, a.s.
  • Univerzitna nemocnica Martin
  • UROEXAM, spol. s r.o.
  • MILAB
  • Fakultna nemocnica s poliklinikou Zilina
  • Althaia, Xarxa Assistencial Universitària de Manresa
  • Hospital Universitari Son Espases
  • Complejo Hospitalario Universitario de Santiago
  • Hospital del Mar
  • Hospital Clinic i Provincial de Barcelona, Dr. Antonio Alcaraz Asensio
  • Hospital Universitario Puerta del Mar
  • ICO Girona; Hospital Universitari de Girona Dr. Josep Trueta. Servicio de Oncologia
  • Hospital Universitario de La Princesa
  • Hospital General Universitario Gregorio Maranon. Servicio de Oncologia.
  • Centro Oncologico MD Anderson International Espana
  • Hospital Universitario Ramon Y Cajal
  • Hospital Universitario 12 de Octubre
  • Althaia, Xarxa Assistencial Universitària de Manresa
  • Complejo Hospitalario Universitario de Orense
  • Corporacio Sanitaria Parc Tauli
  • Hospital Clinico Universitario de Salamanca
  • Instituto Valenciano de Oncologia IVO
  • Sahlgrenska Universitetssjukhuset, Sahlgrenska
  • Skanes Universitetssjukhus
  • Universitetssjukhuset Orebro
  • Sodersjukhuset AB
  • Karolinska Universitetssjukhuset Solna
  • Norrlands Universitetssjukhus
  • Norrlands Universitetssjukhus
  • Akademiska Sjukhuset
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital, Linkou
  • Ross Hall Hospital
  • Royal Devon & Exeter Hospital
  • Royal Free Hospital
  • The Royal Marsden NHS Foundation Trust
  • Cancer Centre, Queen Elizabeth Hospital
  • University Hospitals Bristol NHS Foundation Trust
  • Beatson West of Scotland Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Enzalutamide plus leuprolide

Enzalutamide monotherapy

Leuprolide plus placebo

Arm Description

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

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

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. The randomized blinded portion of the study has concluded following primary endpoint analyses. In the Open Label Period the placebo is no longer applicable in this study arm, and patients continue to receive leuprolide alone.

Outcomes

Primary Outcome Measures

Metastasis-free survival (MFS)
Compared between enzalutamide plus leuprolide and placebo plus leuprolide.

Secondary Outcome Measures

Overall survival
Time to castration resistance
Composite of safety
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.
Metastasis-free survival (MFS)
Compared between enzalutamide monotherapy versus placebo plus leuprolide.
Time to prostate specific antigen (PSA) progression;
Time to first use of new antineoplastic therapy
Time to distant metastasis
Proportion of patients per group who remain treatment free 2 years after suspension of study drug treatment at week 37 due to undetectable PSA
Proportion of patients per group with undetectable PSA 2 years after suspension of study drug treatment at week 37 due to undetectable PSA
Proportion of patients per group with undetectable PSA at 36 weeks on study drug
Time to resumption of any hormonal therapy following suspension at week 37 due to undetectable PSA
Time to symptomatic progression
Time to first symptomatic skeletal event
Time to clinically relevant pain
Quality of life via the Functional Assessment of Cancer Therapy Prostate (FACT P) questionnaire,
Quality of life via the European Quality of Life 5 Dimensions 5 Levels Health Questionnaire (EQ 5D 5L),
Quality of life via the Quality of Life Questionnaire Prostate 25 (QLQ PR25) module

Full Information

First Posted
December 14, 2014
Last Updated
August 4, 2023
Sponsor
Pfizer
Collaborators
Astellas Pharma Inc, Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02319837
Brief Title
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 17, 2014 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
September 19, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Astellas Pharma Inc, Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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. The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The randomized blinded portion of the study has concluded. The study is now being conducted open label manner.
Allocation
Randomized
Enrollment
1068 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enzalutamide plus leuprolide
Arm Type
Experimental
Arm Description
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
Arm Title
Enzalutamide monotherapy
Arm Type
Experimental
Arm Description
Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily
Arm Title
Leuprolide plus placebo
Arm Type
Active Comparator
Arm Description
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. The randomized blinded portion of the study has concluded following primary endpoint analyses. In the Open Label Period the placebo is no longer applicable in this study arm, and patients continue to receive leuprolide alone.
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
MDV3100, Xtandi
Intervention Type
Drug
Intervention Name(s)
Placebo (No longer applicable in Open Label study period)
Intervention Description
Sugar pill to mimic enzalutamide
Intervention Type
Drug
Intervention Name(s)
Leuprolide Open Label
Other Intervention Name(s)
Eligard, Leuprolide Acetate, Leuprorelin, Lupron
Primary Outcome Measure Information:
Title
Metastasis-free survival (MFS)
Description
Compared between enzalutamide plus leuprolide and placebo plus leuprolide.
Time Frame
Up to approximately 90 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
Up to approximately 132 months
Title
Time to castration resistance
Time Frame
Up to approximately 90 months
Title
Composite of safety
Description
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.
Time Frame
Up to approximately 90 months
Title
Metastasis-free survival (MFS)
Description
Compared between enzalutamide monotherapy versus placebo plus leuprolide.
Time Frame
Up to approximately 90 months
Title
Time to prostate specific antigen (PSA) progression;
Time Frame
Up to approximately 90 months
Title
Time to first use of new antineoplastic therapy
Time Frame
Up to approximately 90 months
Title
Time to distant metastasis
Time Frame
Up to approximately 90 months
Title
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 90 months
Title
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 90 months
Title
Proportion of patients per group with undetectable PSA at 36 weeks on study drug
Time Frame
At week 36
Title
Time to resumption of any hormonal therapy following suspension at week 37 due to undetectable PSA
Time Frame
From baseline (week 37) up to 90 months
Title
Time to symptomatic progression
Time Frame
Up to approximately 90 months
Title
Time to first symptomatic skeletal event
Time Frame
Up to approximately 90 months
Title
Time to clinically relevant pain
Time Frame
Up to approximately 90 months
Title
Quality of life via the Functional Assessment of Cancer Therapy Prostate (FACT P) questionnaire,
Time Frame
Up to approximately 90 months
Title
Quality of life via the European Quality of Life 5 Dimensions 5 Levels Health Questionnaire (EQ 5D 5L),
Time Frame
Up to approximately 90 months
Title
Quality of life via the Quality of Life Questionnaire Prostate 25 (QLQ PR25) module
Time Frame
Up to approximately 90 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham, IDS Pharmacy
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Alaska Urological Institute dba Alaska Clinical Research Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99503
Country
United States
Facility Name
Urological Associates of Southern Arizona, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Tower Hematology Oncology Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Cedars-Senai OCC Pharmacy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sutter Medical Group, Vascular & Varicose Vein Center
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Sutter Medical Group
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California, Davis, School of Medicine
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
The Urology Center of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Foothills Urology, P.C.
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Eastern Connecticut Hematology Oncology Associates
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Johns Hopkins Kimmel Cancer Center/ Sibley Infusion
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Lakeland Regional Health Hollis Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Investigational Drug Service
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern Medical Group
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
First Urology, PSC
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
The University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Kansas City Urology Care, PA
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211-1231
Country
United States
Facility Name
The University of Kansas Cancer Center and Medical Pavilion
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
The University of Kansas Cancer Center, Investigational Drug Services
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
GU Research Network/Wichita Urology Group
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
John Hopkins University Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Chesapeake Urology Research Associates
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Comprehensive Urology - Macomb Office
City
Macomb
State/Province
Michigan
ZIP/Postal Code
48044
Country
United States
Facility Name
Comprehensive Urology - Royal Oak (Stephenson) office
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48067
Country
United States
Facility Name
GU Research Network, LLC / Urology Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
VA Lahontan Valley Outpatient Clinic
City
Fallon
State/Province
Nevada
ZIP/Postal Code
89406
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Sidney Kimmel Center for Prostate and Urologic Cancers
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley PC
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center Rockville Centre
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Associated Medical Professionals of New York, PLLC
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Facility Name
Duke Investigational Chemotherapy Services
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Duke Nuclear Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Alliance Urology Specialists, PA
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
TriState Urologic Services PSC Inc., dba The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Mercy Health Jewish Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Clinical Research Solutions
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Southwest Urology
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
OU Medical Center Presbyterian Tower
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73140
Country
United States
Facility Name
Oregon Imaging Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Oregon Urology Institute
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Urologic Consultants of SE PA
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Keystone Urology Specialists
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Lancaster Urology
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19083
Country
United States
Facility Name
Jefferson Medical Oncology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Jefferson Urology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson University Hospital, Bodine Buiding
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson University, Medical Oncology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Thomas Jefferson University, Sidney Kimmel Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Vanderbilt Unversity Medical Center, The Urology Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Urology Clinics of North Texas, PLLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Houston Metro Urology
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Henrico Doctor's Hospital
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Virginia Urology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Urology of Virginia, PLLC.
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Genesis Cancer Care NSW
City
Gateshead
State/Province
New South Wales
ZIP/Postal Code
2290
Country
Australia
Facility Name
Lismore Base hospital
City
Lismore
State/Province
New South Wales
ZIP/Postal Code
2480
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Macquarie University
City
North Ryde
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Genesis Cancer Care
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Facility Name
Port Macquarie Base Hospital
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
GenesisCare North Shore
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
The Tweed Hospital
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Facility Name
Australian Clinical Trials Pty Ltd
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Sydney Adventist Hospital
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Illawarra Cancer Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Crown Princess Mary Cancer Centre
City
Westmead
State/Province
NEW
ZIP/Postal Code
2145
Country
Australia
Facility Name
Icon Cancer Care Wesley
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Icon Cancer Care Chermside
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Icon Cancer Care South Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Icon Cancer Foundation
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Icon Cancer Centre Southport
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Australian Urology Associates
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Sunshine Hospital
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Hospital Barmherzige Schwestern Linz
City
Linz
State/Province
Upper Austria
ZIP/Postal Code
4010
Country
Austria
Facility Name
Hospital Barmherzige Schwestern Linz, Department of Urology
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Ordensklinikum Linz GmbH
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Austria
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Department of Radiology, University Hospital Salzburg, Austria
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Department of Urology,Paracelsus Medical University Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
AKH - Medizinische Universität Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Department of Internal Medicine I, Medical university Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hospital São Rafael S.A
City
Salvador
State/Province
BA
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
CITO - Centro Integrado de Terapia Onco-Hematologica - Hospital de Clinicas de Passo Fundo
City
Passo Fundo
State/Province
RS
ZIP/Postal Code
99010-260
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90430-090
Country
Brazil
Facility Name
Hospital Sao Lucas da PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-0000
Country
Brazil
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP
City
Campinas
State/Province
SP
ZIP/Postal Code
13083-970
Country
Brazil
Facility Name
Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
City
Santo Andre
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Oncosite - Centro de Pesquisa Clinica em Oncologia Ltda
City
Ijuí/RS
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Prostate Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Vancouver Prostate Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Manitoba Prostate Centre CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
The Male/Female Health and Research Centre, Royal Court Medical Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Centre for Applied Urological Research
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3J7
Country
Canada
Facility Name
Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada
Facility Name
Urology Associates/ Urologic Medical Research
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2B9
Country
Canada
Facility Name
London Health Sciences Centre - Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network - Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Urology South Shore Research
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H3
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Ultra-Med Inc.
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
CHU de Quebec - L'Hotel-Dieu de Quebec
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
CHU de Quebec - L'Hotel-Dieu de Quebec - CRCEO
City
Quebec
ZIP/Postal Code
G1R 3S1
Country
Canada
Facility Name
Aarhus University Hospital
City
Arhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet - Copenhagen University Hospital
City
Copenhagen N
ZIP/Postal Code
2200
Country
Denmark
Facility Name
Rigshospitalet - Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Rigshospitalet, Dept of Radiology
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense University Hospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Vejle Sygehus
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Helsingin yliopistollinen keskussairaala
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Oulun yliopistollinen sairaala
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Satakunnan Keskussairaala
City
Pori
ZIP/Postal Code
28500
Country
Finland
Facility Name
Seinaejoen Keskussairaala
City
Seinaejoki
ZIP/Postal Code
60220
Country
Finland
Facility Name
Tampereen yliopistollinen sairaala
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
ICO- site Paul Papin
City
Angers cedex 09
ZIP/Postal Code
49933
Country
France
Facility Name
Clinique Pasteur - Lanroze Service Pharmacie
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Clinique Pasteur - Lanroze
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHD Vendée
City
LA ROCHE SUR YON cedex 9
ZIP/Postal Code
85925
Country
France
Facility Name
CHRU de Lille - Hopital Claude Huriez
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Facility Name
ICM Val d'Aurelle
City
Montpellier Cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
CHU de Nantes - Hotel Dieu
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Hopital Saint-Louis
City
Paris cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris Cedex 14
ZIP/Postal Code
75674
Country
France
Facility Name
CHP Saint-Gregoire
City
Saint-Gregoire
ZIP/Postal Code
35760
Country
France
Facility Name
ICO - site Rene Gauducheau
City
Saint-Herblain cedex
ZIP/Postal Code
44805
Country
France
Facility Name
Hia Begin
City
Saint-Mande
ZIP/Postal Code
94160
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Farmacia, Azienda Socio Sanitaria Territoriale di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
UO di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
UO di Oncologia,Ospedale Civile degli Infermi
City
Faenza RA
ZIP/Postal Code
48018
Country
Italy
Facility Name
UO di Radiologia, Ospedale Civile degli Infermi
City
Faenza RA
ZIP/Postal Code
48018
Country
Italy
Facility Name
UO di Oncologia, Ospedale Civile Umberto I
City
Lugo RA
ZIP/Postal Code
48022
Country
Italy
Facility Name
Uo di Radiologia, Ospedale Civile Umberto I
City
Lugo RA
ZIP/Postal Code
48022
Country
Italy
Facility Name
Laboratorio Farmaci Antiblastici, IRCCS Istituto
City
Meldola (FC)
ZIP/Postal Code
47014
Country
Italy
Facility Name
U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
City
Meldola (FC)
ZIP/Postal Code
47014
Country
Italy
Facility Name
UO Radiologia,IRCCS Istituto Scientifico Romagnolo Per lO Studio e la Cura dei Tumori (IRST)
City
Meldola (FC)
ZIP/Postal Code
47014
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione G. Pascale/Oncologia Medica A
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
S.C.D.U. Oncologia Medica, A.O.U. San Luigi Gonzaga
City
Orbassano (TO)
ZIP/Postal Code
10043
Country
Italy
Facility Name
S.C.D.U. Radiodiagnostica, A.O.U. San Luigi Gonzaga
City
Orbassano (TO)
ZIP/Postal Code
10043
Country
Italy
Facility Name
Servizio di Farmacia, Ospedale Santa Maria delle Croci
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Servizio di Radiologia, Ospedale Santa Maria Delle Croci
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
UO di Oncologia Medica, Ospedale Santa Maria delle Croci
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Farmacia Interna, Ospedale degli Infermi
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Facility Name
UO Oncologia, Ospedale degli Infermi
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Facility Name
Azienda Ospedaliera S, Camillo Forlanini, UOC per il governo clinico in Oncologia Medica,pad,Flajani
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
U.O. di Oncologia Medica, Ospedale Santa Chiara
City
Trento
ZIP/Postal Code
38122
Country
Italy
Facility Name
U.O. Medicina Nucleare, Ospedale Santa Chiara
City
Trento
ZIP/Postal Code
38122
Country
Italy
Facility Name
U.O. Radiologia, Ospedale Santa Chiara
City
Trento
ZIP/Postal Code
38122
Country
Italy
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan-si
State/Province
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun-gun
State/Province
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Severance Hospital. Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
VU Medical Centrum, Department of Urology
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1105AZ
Country
Netherlands
Facility Name
Gelderse Vallei Ziekenhuis
City
Ede
ZIP/Postal Code
6710 HN
Country
Netherlands
Facility Name
Catharina Ziekenhuis Eindhoven
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
University Medical Centrum Groningen, Department Urologie
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Maastricht University Medical Center, Department of Urology
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Antonius Ziekenhuis
City
Sneek
ZIP/Postal Code
8601 ZK
Country
Netherlands
Facility Name
Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o. o.
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Urologiczny
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Centrum Medyczne Melita Medical
City
Wroclaw
ZIP/Postal Code
50-449
Country
Poland
Facility Name
EMC Instytut Medyczny Spolka Akcyjna
City
Wroclaw
ZIP/Postal Code
54-144
Country
Poland
Facility Name
Fakultna nemocnica s poliklinikou F.D.Roosevelta
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
CUIMED, s.r.o., Urologicka ambulancia
City
Bratislava
ZIP/Postal Code
851 05
Country
Slovakia
Facility Name
Vychodoslovensky onkologicky ustav, a.s.
City
Kosice
ZIP/Postal Code
041 91
Country
Slovakia
Facility Name
Univerzitna nemocnica Martin
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
UROEXAM, spol. s r.o.
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
MILAB
City
Presov
ZIP/Postal Code
080 81
Country
Slovakia
Facility Name
Fakultna nemocnica s poliklinikou Zilina
City
Zilina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
Althaia, Xarxa Assistencial Universitària de Manresa
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
Facility Name
Hospital Universitari Son Espases
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07010
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago de Compostela
State/Province
LA Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona, Dr. Antonio Alcaraz Asensio
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Puerta del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
ICO Girona; Hospital Universitari de Girona Dr. Josep Trueta. Servicio de Oncologia
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon. Servicio de Oncologia.
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Centro Oncologico MD Anderson International Espana
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Althaia, Xarxa Assistencial Universitària de Manresa
City
Manresa
ZIP/Postal Code
08243
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Orense
City
Orense
ZIP/Postal Code
32005
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Instituto Valenciano de Oncologia IVO
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhuset, Sahlgrenska
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Skanes Universitetssjukhus
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Universitetssjukhuset Orebro
City
Orebro
ZIP/Postal Code
70 185
Country
Sweden
Facility Name
Sodersjukhuset AB
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Solna
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Norrlands Universitetssjukhus
City
Umea
ZIP/Postal Code
90 185
Country
Sweden
Facility Name
Norrlands Universitetssjukhus
City
Umea
ZIP/Postal Code
90185
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Ross Hall Hospital
City
Glasgow
State/Province
CITY OF Glasgow
ZIP/Postal Code
G52 3NQ
Country
United Kingdom
Facility Name
Royal Devon & Exeter Hospital
City
Wonford, Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Cancer Centre, Queen Elizabeth Hospital
City
Birmingham
State/Province
WEST Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
University Hospitals Bristol NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 OYN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
34385241
Citation
Freedland SJ, De Giorgi U, Gleave M, Rosbrook B, Shen Q, Sugg J, Haas GP, Shore ND. A phase 3 randomised study of enzalutamide plus leuprolide and enzalutamide monotherapy in high-risk non-metastatic hormone-sensitive prostate cancer with rising PSA after local therapy: EMBARK study design. BMJ Open. 2021 Aug 12;11(8):e046588. doi: 10.1136/bmjopen-2020-046588.
Results Reference
derived

Learn more about this trial

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

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