Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

509

Participants

Timeline

Start Date

October 22, 2013

Primary Completion Date

November 15, 2016

Study Completion Date

August 31, 2022

Conditions
Prostate Cancer
Interventions
DRUG

Enzalutamide

160 mg by mouth once daily

DRUG

Abiraterone

1000 mg by mouth once daily

DRUG

Placebo for Enzalutamide

Sugar pill manufactured to mimic Enzalutamide 40 mg capsule

DRUG

Prednisone

5 mg by mouth twice daily

Trial Locations (95)

1200

Cliniques universitaires saint-Luc, Brussels

2000

Frederiksberg Hospital, Frederiksberg

2065

North Shore Radiology and Nuclear Medicine, St Leonards

Royal North Shore Hospital, St Leonards

2076

Sydney Adventist Hospital, Sydney

Sydney Adventist Hospital, Wahroonga

2100

Rigshospitalet, Copenhagen

2109

Macquarie University Hospital Pharmacy, North Ryde

Macquarie University, North Ryde

2139

Concord Cancer Centre, Medical Oncology Department, Concord

Concord Hospital Clinical Trials Pharmacy, Concord

2145

Westmead Hospital, Westmead

2200

Rigshospitalet CPC 7521, Copenhagen

2444

Epic Pharmacy Port Macquarie base hospital, Port Macquarie

Port Macquarie Base Hospital,North Coast Cancer Institute, Port Macquarie

2480

Epic Pharmacy Lismore, Lismore

2485

Northern NSW Local Health District, Tweed Heads

Queensland Diagnostic Imaging, Tweed Heads

2640

Border Medical Oncology Research Unit, Albury

Ramsay Health Care Australia Pty Ltd, Albury

Regional Imaging Border, Albury

Terry White Chemist, Albury

Regional Imaging, West Albury

3000

Universitaire Ziekenhuizen Leuven, Leuven

3128

Box Hill Hospital, Box Hill

3144

Cabrini Health - Cabrini Hospital, Malvern

3165

Moorabbin Radiology, Bentleigh East

3168

Monash Medical Centre, Clayton

3690

Border Medical Oncology, Wodonga

4032

Icon Cancer Care Chermside, Chermside

4066

Icon Cancer Care Wesley, Auchenflower

River City Pharmacy - APHS, Auchenflower

4101

Icon Cancer Care South Brisbane, South Brisbane

Icon Cancer Care, South Brisbane

4212

Gold Coast Radiology PTY LTD, Hope Island

4224

South Coast Radiology, Tugun

5037

Adelaide Cancer Centre, Kurralta Park

Ashford Cancer Centre Research, Kurralta Park

Cancer Care SA Pty Ltd, Kurralta Park

Tenpharm Pty Ltd trading as EPIC Pharmacy Tennyson, Kurralta Park

8200

Arhus Universitetshospital, Arhus N

8500

Algemeen Ziekenhuis Groeninge, Kortrijk

10043

SCDU Oncologia Medica II Pad, A.O.U. San Luigi Gonzaga, Orbassano to

SCDU Radiodiagnostica, A.O.U. San Luigi Gonzaga, Orbassano to

SS Medicina Nucleare, A.O.U. San Luigi Gonzaga, Orbassano to

19103

eResearch Technology, Philadelphia

20502

Urologiska kliniken, Malmo

23462

Urology of Virginia, PLLC, Virginia Beach

26100

"Medicina Nucleare, Azienda Ospedaliera Istituti Ospitalieri di Cremona", Cremona

"Servizio di Radiologia, Azienda Ospedaliera Istituti Ospitalieri di Cremona", Cremona

Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona, Cremona

28050

Hospital Universitario Madrid Sanchinarro, Madrid

33520

Tampereen yliopistollinen Sairaala, Tampere

41345

Urologmottagningen, Gothenburg

47014

U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura, Meldola

Laboratorio Farmaci Antiblastici, Meldola (FC)

UO Radiologia, Meldola (FC)

90220

Oulun yliopistollinen sairaala, Oulu

94805

Institut Gustave Roussy - Service d'Urologie, Villejuif

97517

Fakultna nemocnica s poliklinikou F.D. Roosevelta, Banská Bystrica

02115

Beth Israel Deaconess Medical Center, Boston

Brigham & Women's Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Dana Farber Cancer Institute, Boston

00290

Helsingin yliopistollinen keskussairaala, Meilahden sairaala, Helsinki

00152

Azienda Ospedaliera S. Camillo Forlanini, UOC per il governo clinico in Oncologia Medica, Roma

00512

UOC Radiologia Piasta, Azienda Ospedaliera S. Camillo Forlanini, Roma

975 17

Fakultna nemocnica s poliklinikou F.D. Roosevelta, Banská Bystrica

Institut nuklearnej a molekularnej mediciny, Banská Bystrica

814 99

Bratislavske radiodiagnosticke centrum,a.s., Bratislava

851 05

CUIMED, s.r.o., urologicka ambulancia, Bratislava

036 59

Univerzitna nemocnica martin, Martin

949 01

Jessenius-diagnosticke centrum, a.s., Nitra

Uroexam, spol. s r.o., Urologicka ambulancia, Nitra

950 01

IZOTOPCENTRUM, s.r.o., Nitra

917 01

GAMMALAB, spol.s r.o., Oddelenie nuklearnej mediciny, Trnava

07120

Hospital Universitario Son Espases, Palma

08916

CO Badalona-Instituto Germans Trias i Pujol, Badalona

ICO Badalona-Instituto Germans Trias i Pujol, Badalona

ICO Badalona-Instituto Germans Trias i Pujol, Badalona

08243

ALTAHIA, Xarxa Assistencial Universitaria de Manresa, Manresa

08208

Hospital Universitari Parc Tauli, Sabadell

08003

Hospital del Mar, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

435 25

Oriola, Mölnlycke

435 33

Apoteket AB Kliniska Provningar Molnlycke, Mölnlycke

701 85

Rontgenkliniken, Örebro

Urologmottagningen, Örebro

HA6 2RN

East and North Hertfordshire NHS Trust, Northwood

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

CF14 2TL

Velindre NHS Trust, Cardiff

NW1 2BU

University College Hospitals NHS Trust, London

SW3 6JJ

The Royal Marsden NHS Foundation Trust, London

WC1E 6AG

University College London Hospitals NHS Foundation Trust, London

OX3 7LE

Oxford University Hospitals NHS Trust, Oxford

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Astellas Pharma Inc

INDUSTRY

collaborator

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

INDUSTRY

lead

Pfizer

INDUSTRY

NCT01995513 - Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients | Biotech Hunter | Biotech Hunter