Clinical trial NCT02319837: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hormone Sensitive Prostate Cancer
Prostate Cancer
Cancer of the Prostate
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Inc
name: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
First posted: 2014-12-18
Enrollment: 1068
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Metastasis-free Survival (MFS) Compared Between Enzalutamide Plus Leuprolide and Placebo Plus Leuprolide
timeFrame: From randomization until radiographic progression or death without radiographic progression, whichever occurred first (up to Month 98 when at least 197 MFS events occurred among the 3 treatment groups)
Secondary outcomes:
measure: Metastasis-free Survival (MFS) Compared Between Enzalutamide Monotherapy and Placebo Plus Leuprolide
timeFrame: From randomization until radiographic progression or death without radiographic progression, whichever occurred first (up to Month 98 when at least 197 MFS events occurred among the 3 treatment groups)
measure: Time to Prostate-specific Antigen (PSA) Progression
timeFrame: From randomization until first PSA progression (up to Month 98)
measure: Time to First Use of New Antineoplastic Therapy
timeFrame: From randomization until first use of new antineoplastic therapy (up to Month 98)
measure: Overall Survival (OS)
timeFrame: From randomization until death due to any cause (up to Month 98 when at least 197 MFS events occurred among the 3 treatment groups)
measure: Time to Distant Metastasis
timeFrame: From randomization until the earliest objective evidence of distant soft tissue metastases or metastatic bone disease (up to Month 98)
measure: Percentage of Participants With Undetectable Prostate-specific Antigen (PSA) at 36 Weeks on Study Drug
timeFrame: At Week 36
measure: Percentage of Participants Who Remained Treatment-free 2 Years After Suspension of Study Treatment at Week 37 Due to Undetectable Prostate-specific Antigen (PSA)
timeFrame: From randomization until 2 years after Week 37 (up to Month 34)
measure: Percentage of Participants With Undetectable Prostate-specific Antigen (PSA) 2 Years After Suspension of Treatment at Week 37 Due to Undetectable PSA
timeFrame: From randomization until 2 years after Week 37 (up to Month 34)
measure: Time to Resumption of Any Hormonal Therapy Following Suspension at Week 37 Due to Undetectable Prostate-specific Antigen (PSA)
timeFrame: From treatment suspension at Week 37 until resumption of any hormonal therapy (up to Month 98)
measure: Time to Castration Resistance
timeFrame: From randomization to the first occurrence of radiographic disease progression, PSA progression or SSE, whichever occurred first with castrate levels of testosterone (up to Month 98)
measure: Time to Symptomatic Progression
timeFrame: From randomization until the first development of events defined as symptomatic progression (up to Month 98)
measure: Time to First Symptomatic Skeletal Event (SSE)
timeFrame: From randomization until the first development of events defined as SSE (up to Month 98)
measure: Time From Randomization to Onset of Clinically Relevant Pain Progression, Defined as a 2-point or Greater Increase From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Question 3 Score
timeFrame: From randomization until a 2-point or greater increase from baseline in the BPI-SF question 3 score (up to Month 98)
measure: Time From Randomization to First Assessment With at Least a 10-point Decline (Deterioration) From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score
timeFrame: From randomization to first assessment with at least a 10-point decrease from baseline in the FACT-P total score (up to Month 98)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) (All-causality) During On-treatment Period, Modified Treatment Period, and Treatment Reinitiation Period - at PCD Cut-off Date of 31 January 2023
timeFrame: From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
measure: Number of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs) (All-causality) - at PCD Cut-off Date of 31 January 2023
timeFrame: From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Treatment-related) During On-treatment Period, Modified Treatment Period, and Treatment Reinitiation Period - at PCD Cut-off Date of 31 January 2023
timeFrame: From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
measure: Number of Participants With SAEs (All-causality) During On-treatment Period, Modified Treatment Period and Treatment Reinitiation Period and SAEs (Treatment-related) During On-treatment period-at PCD Cut-off 31 Jan 2023
timeFrame: From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Enzalutamide or Placebo Discontinuation - at PCD Cut-off Date of 31 January 2023
timeFrame: From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
measure: Number of Participants With Shifts From Grade ≤2 at Baseline to Grade 3 or Grade 4 Post-baseline in Hematology Laboratory Test Values - at PCD Cut-off Date of 31 January 2023
timeFrame: From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
measure: Number of Participants With Shifts From Grade ≤2 at Baseline to Grade 3 or Grade 4 Post-baseline in Chemistry Laboratory Test Values - at PCD Cut-off Date of 31 January 2023
timeFrame: From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
measure: Number of Participants With Potentially Clinically Significant Vital Signs - at PCD Cut-off Date of 31 January 2023
timeFrame: From first dose of study drug to the last dose + 30 days, or the day before initiation of a new antineoplastic treatment (up to Month 98)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, IDS Pharmacy
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Anchorage
country: United States
facility: Alaska Urological Institute dba Alaska Clinical Research Center
state: Alaska
city: Tucson
country: United States
facility: Urological Associates of Southern Arizona, PC
state: Arizona
city: Beverly Hills
country: United States
facility: Tower Hematology Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: Cedars-Senai OCC Pharmacy
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Roseville
country: United States
facility: Sutter Medical Group, Vascular & Varicose Vein Center
state: California
city: Roseville
country: United States
facility: Sutter Medical Group
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis, School of Medicine
state: California
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Golden
country: United States
facility: Foothills Urology, P.C.
state: Colorado
city: Norwich
country: United States
facility: Eastern Connecticut Hematology Oncology Associates
state: Connecticut
city: Lakeland
country: United States
facility: Lakeland Regional Health Hollis Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medical Group
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Jeffersonville
country: United States
facility: First Urology, PSC
state: Indiana
city: Kansas City
country: United States
facility: The University of Kansas Hospital
state: Kansas
city: Overland Park
country: United States
facility: Kansas City Urology Care, PA
state: Kansas
city: Westwood
country: United States
facility: The University of Kansas Cancer Center and Medical Pavilion
state: Kansas
city: Wichita
country: United States
facility: GU Research Network/Wichita Urology Group
state: Kansas
city: Baltimore
country: United States
facility: John Hopkins University Hospital
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Baltimore
country: United States
facility: The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services
state: Maryland
city: Towson
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Macomb
country: United States
facility: Comprehensive Urology - Macomb Office
state: Michigan
city: Royal Oak
country: United States
facility: Comprehensive Urology - Royal Oak (Stephenson) office
state: Michigan
city: Omaha
country: United States
facility: GU Research Network, LLC / Urology Cancer Center
state: Nebraska
city: Fallon
country: United States
facility: VA Lahontan Valley Outpatient Clinic
state: Nevada
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Cancer Center Westchester
state: New York
city: New York
country: United States
facility: Memorial Hospital
state: New York
city: New York
country: United States
facility: Sidney Kimmel Center for Prostate and Urologic Cancers
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley PC
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Cancer Center Rockville Centre
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of New York, PLLC
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Cancer Center Nassau
state: New York
city: Durham
country: United States
facility: Duke Investigational Chemotherapy Services
state: North Carolina
city: Durham
country: United States
facility: Duke Nuclear Medicine
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Alliance Urology Specialists, PA
state: North Carolina
city: Cincinnati
country: United States
facility: TriState Urologic Services PSC Inc., dba The Urology Group
state: Ohio
city: Cincinnati
country: United States
facility: Mercy Health Jewish Hospital
state: Ohio
city: Middleburg Heights
country: United States
facility: Clinical Research Solutions
state: Ohio
city: Middleburg Heights
country: United States
facility: Southwest Urology
state: Ohio
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Eugene
country: United States
facility: Oregon Imaging Center
state: Oregon
city: Springfield
country: United States
facility: Oregon Urology Institute
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of SE PA
state: Pennsylvania
city: Lancaster
country: United States
facility: Keystone Urology Specialists
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
state: Pennsylvania
city: Philadelphia
country: United States
facility: Honickman Centre
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital, Bodine Buiding
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University, Medical Oncology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University, Sidney Kimmel Cancer Center
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Unversity Medical Center, Dept. of Urologic Surgery
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Unversity Medical Center, The Urology Clinic
state: Tennessee
city: Dallas
country: United States
facility: Urology Clinics of North Texas, PLLC
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Henrico
country: United States
facility: Henrico Doctor's Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLLC.
state: Virginia
city: Gateshead
country: Australia
facility: Genesis Cancer Care NSW
state: New South Wales
city: Lismore
country: Australia
facility: Lismore Base hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: North Ryde
country: Australia
facility: Macquarie University
state: New South Wales
city: North Sydney
country: Australia
facility: Genesis Cancer Care
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: GenesisCare North Shore
state: New South Wales
city: Tweed Heads
country: Australia
facility: The Tweed Hospital
state: New South Wales
city: Wahroonga
country: Australia
facility: Australian Clinical Trials Pty Ltd
state: New South Wales
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Illawarra Cancer Care Centre
state: New South Wales
city: Westmead
country: Australia
facility: Crown Princess Mary Cancer Centre
state: NEW
city: Auchenflower
country: Australia
facility: Icon Cancer Care Wesley
state: Queensland
city: Chermside
country: Australia
facility: Icon Cancer Care Chermside
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Care South Brisbane
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Foundation
state: Queensland
city: Southport
country: Australia
facility: Icon Cancer Centre Southport
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Malvern
country: Australia
facility: Australian Urology Associates
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Linz
country: Austria
facility: Hospital Barmherzige Schwestern Linz
state: Upper Austria
city: Linz
country: Austria
facility: Hospital Barmherzige Schwestern Linz, Department of Urology
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH
city: Salzburg
country: Austria
facility: Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Austria
city: Salzburg
country: Austria
facility: Department of Radiology, University Hospital Salzburg, Austria
city: Salzburg
country: Austria
facility: Department of Urology,Paracelsus Medical University Salzburg
city: Vienna
country: Austria
facility: AKH - Medizinische Universität Wien
city: Vienna
country: Austria
facility: Department of Internal Medicine I, Medical university Vienna
city: Salvador
country: Brazil
facility: Hospital São Rafael S.A
state: BA
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
state: Parana
city: Passo Fundo
country: Brazil
facility: CITO - Centro Integrado de Terapia Onco-Hematologica - Hospital de Clinicas de Passo Fundo
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
state: RS
city: Barretos
country: Brazil
facility: Fundacao Pio XII - Hospital de Cancer de Barretos
state: SP
city: Campinas
country: Brazil
facility: Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP
state: SP
city: Santo Andre
country: Brazil
facility: Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
state: SP
city: Ijuí/RS
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica em Oncologia Ltda
city: Calgary
country: Canada
facility: Prostate Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver Prostate Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Prostate Centre CancerCare Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Barrie
country: Canada
facility: The Male/Female Health and Research Centre, Royal Court Medical Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Kingston
country: Canada
facility: Centre for Applied Urological Research
state: Ontario
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
city: Kitchener
country: Canada
facility: Urology Associates/ Urologic Medical Research
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - Victoria Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Princess Margaret Cancer Centre
state: Ontario
city: Greenfield Park
country: Canada
facility: Urology South Shore Research
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Pointe-Claire
country: Canada
facility: Ultra-Med Inc.
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec - L'Hotel-Dieu de Quebec
city: Quebec
country: Canada
facility: CHU de Quebec - L'Hotel-Dieu de Quebec - CRCEO
city: Arhus N
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen N
country: Denmark
facility: Rigshospitalet - Copenhagen University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet - Copenhagen University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Dept of Radiology
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Vejle
country: Denmark
facility: Vejle Sygehus
city: Helsinki
country: Finland
facility: Helsingin yliopistollinen keskussairaala
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala
city: Pori
country: Finland
facility: Satakunnan Keskussairaala
city: Seinaejoki
country: Finland
facility: Seinaejoen Keskussairaala
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
city: Angers cedex 09
country: France
facility: ICO- site Paul Papin
city: Brest
country: France
facility: Clinique Pasteur - Lanroze Service Pharmacie
city: Brest
country: France
facility: Clinique Pasteur - Lanroze
city: LA ROCHE SUR YON cedex 9
country: France
facility: CHD Vendée
city: Lille cedex
country: France
facility: CHRU de Lille - Hopital Claude Huriez
city: Montpellier Cedex 5
country: France
facility: ICM Val d'Aurelle
city: Nantes
country: France
facility: CHU de Nantes - Hotel Dieu
city: Paris cedex 10
country: France
facility: Hopital Saint-Louis
city: Paris Cedex 14
country: France
facility: Institut Mutualiste Montsouris
city: Saint-Gregoire
country: France
facility: CHP Saint-Gregoire
city: Saint-Herblain cedex
country: France
facility: ICO - site Rene Gauducheau
city: Saint-Mande
country: France
facility: Hia Begin
city: Suresnes
country: France
facility: Hopital Foch
city: Villejuif cedex
country: France
facility: Institut Gustave Roussy
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Cremona
country: Italy
facility: Farmacia, Azienda Socio Sanitaria Territoriale di Cremona
city: Cremona
country: Italy
facility: Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
city: Cremona
country: Italy
facility: UO di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona
city: Faenza RA
country: Italy
facility: UO di Oncologia,Ospedale Civile degli Infermi
city: Faenza RA
country: Italy
facility: UO di Radiologia, Ospedale Civile degli Infermi
city: Lugo RA
country: Italy
facility: UO di Oncologia, Ospedale Civile Umberto I
city: Lugo RA
country: Italy
facility: Uo di Radiologia, Ospedale Civile Umberto I
city: Meldola (FC)
country: Italy
facility: Laboratorio Farmaci Antiblastici, IRCCS Istituto
city: Meldola (FC)
country: Italy
facility: U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Meldola (FC)
country: Italy
facility: UO Radiologia,IRCCS Istituto Scientifico Romagnolo Per lO Studio e la Cura dei Tumori (IRST)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione G. Pascale/Oncologia Medica A
city: Orbassano (TO)
country: Italy
facility: S.C.D.U. Oncologia Medica, A.O.U. San Luigi Gonzaga
city: Orbassano (TO)
country: Italy
facility: S.C.D.U. Radiodiagnostica, A.O.U. San Luigi Gonzaga
city: Ravenna
country: Italy
facility: Servizio di Farmacia, Ospedale Santa Maria delle Croci
city: Ravenna
country: Italy
facility: Servizio di Radiologia, Ospedale Santa Maria Delle Croci
city: Ravenna
country: Italy
facility: UO di Oncologia Medica, Ospedale Santa Maria delle Croci
city: Rimini
country: Italy
facility: Farmacia Interna, Ospedale degli Infermi
city: Rimini
country: Italy
facility: UO Oncologia, Ospedale degli Infermi
city: Roma
country: Italy
facility: Azienda Ospedaliera S, Camillo Forlanini, UOC per il governo clinico in Oncologia Medica,pad,Flajani
city: Trento
country: Italy
facility: U.O. di Oncologia Medica, Ospedale Santa Chiara
city: Trento
country: Italy
facility: U.O. Medicina Nucleare, Ospedale Santa Chiara
city: Trento
country: Italy
facility: U.O. Radiologia, Ospedale Santa Chiara
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Yangsan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam-do
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital. Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Amsterdam
country: Netherlands
facility: VU Medical Centrum, Department of Urology
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Ede
country: Netherlands
facility: Gelderse Vallei Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Eindhoven
city: Groningen
country: Netherlands
facility: University Medical Centrum Groningen, Department Urologie
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center, Department of Urology
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o. o.
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Oddzial Urologiczny
city: Torun
country: Poland
facility: Kujawsko-Pomorskie Centrum Urologicznw Sp z o.o
city: Wroclaw
country: Poland
facility: Centrum Medyczne Melita Medical
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny Spolka Akcyjna
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D.Roosevelta
city: Bratislava
country: Slovakia
facility: CUIMED, s.r.o., Urologicka ambulancia
city: Kosice
country: Slovakia
facility: Vychodoslovensky onkologicky ustav, a.s.
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin
city: Nitra
country: Slovakia
facility: UROEXAM, spol. s r.o.
city: Presov
country: Slovakia
facility: MILAB
city: Zilina
country: Slovakia
facility: Fakultna nemocnica s poliklinikou Zilina
city: Manresa
country: Spain
facility: Althaia, Xarxa Assistencial Universitària de Manresa
state: Barcelona
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
state: Islas Baleares
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: LA Coruna
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona, Dr. Antonio Alcaraz Asensio
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Girona
country: Spain
facility: ICO Girona; Hospital Universitari de Girona Dr. Josep Trueta. Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon. Servicio de Oncologia.
city: Madrid
country: Spain
facility: Centro Oncologico MD Anderson International Espana
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Orense
country: Spain
facility: Complejo Hospitalario Universitario de Orense
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia IVO
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset, Sahlgrenska
city: Malmo
country: Sweden
facility: Skanes Universitetssjukhus
city: Orebro
country: Sweden
facility: Universitetssjukhuset Orebro
city: Stockholm
country: Sweden
facility: Sodersjukhuset AB
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
city: Umea
country: Sweden
facility: Norrlands Universitetssjukhus
city: Umea
country: Sweden
facility: Norrlands Universitetssjukhus
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
city: Glasgow
country: United Kingdom
facility: Ross Hall Hospital
state: CITY OF Glasgow
city: Wonford
country: United Kingdom
facility: Royal Devon & Exeter Hospital
state: Devon
city: London
country: United Kingdom
facility: Royal Free Hospital
state: Greater London
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
city: Birmingham
country: United Kingdom
facility: Cancer Centre, Queen Elizabeth Hospital
state: WEST Midlands
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.