A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,150

Participants

Timeline

Start Date

March 9, 2016

Primary Completion Date

October 14, 2018

Study Completion Date

July 31, 2024

Conditions
Metastatic Hormone Sensitive Prostate Cancer
Interventions
DRUG

Enzalutamide

Oral

DRUG

Placebo

Oral

Trial Locations (203)

112

Site TW88601, Kaohsiung City

333

Site TW88607, Taoyuan District

2050

Site AU61016, Camperdown

2065

Site AU61007, St Leonards

2298

Site AU61013, Waratah

2485

Site AU61009, Tweed Heads

4000

Site AR54007, San Miguel de Tucumán

5011

Site AU61001, Woodville South

10060

Site IT39009, Candiolo

12550

Site US10025, Newburgh

13210

Site US10029, Syracuse

14076

Site FR33014, Caen

17604

Site US10011, Lancaster

20246

Site DE49014, Hamburg

21204

Site US10017, Towson

23462

Site US10040, Virginia Beach

27710

Site US10014, Durham

27834

Site US10060, Greenville

28025

Site US10009, Concord

28207

Site US10068, Charlotte

29572

Site US10012, Myrtle Beach

31792

Site US10054, Thomasville

33710

Site US10048, St. Petersburg

35209

Site US10016, Homewood

37208

Site US10059, Nashville

38100

Site IT39011, Trento

40705

Site TW88606, Taichung

44130

Site US10044, Middleburg Heights

47130

Site US10045, Jeffersonville

50266

Site US10020, West Des Moines

53111

Site DE49005, Bonn

60637

Site US10015, Chicago

62703

Site US10043, Springfield

68114

Site US10036, Omaha

69120

Site DE49013, Heidelberg

75231

Site US10046, Dallas

80045

Site US10035, Aurora

80220

Site US10050, Denver

85741

Site US10008, Tucson

92093

Site US10056, La Jolla

92708

Site US10034, Fountain Valley

94010

Site FR33003, Créteil

95403

Site US10026, Santa Rosa

98101

Site US10013, Seattle

98166

Site US10002, Burien

98801

Site US10028, Wenatchee

99503

Site US10007, Anchorage

66160-7233

Site US10055, Kansas City

08648

Site US10018, Lawrenceville

75390-9110

Site US10004, Dallas

S2000DSV

Site AR54002, Rosario

C1180AAX

Site AR54010, Buenos Aires

Unknown

Site AU61006, Sydney

Site AU61004, Ballarat

Site AU61015, Clayton

Site AU61017, Parkville

Site AU61008, St Albans

Site BE32001, Mons

Site BE32012, Ghent

Site BE32005, Kortrijk

Site BE32008, Liège

Site BE32007, Yvoir

Site CL56002, Temuco

Site CL56005, Viña del Mar

Site CL56001, Santiago

Site CL56007, Providencia

Site CL56004, Reñaca

Site CL56003, Santiago

Site DK45005, Aarhus

Site DK45008, Holstebro

Site DK45002, Copenhagen

Site DK45004, Aalborg

Site DK45003, Herlev

Site DK45001, Odense C

Site FI35802, Helsinki

Site FI35804, Pori

Site FI35803, Seinäjoki

Site FI35801, Tampere

Site FI35806, Jakobstad

Site FI35805, Oulu

Site FI35807, Turku

Site FR33010, Angers

Site FR33006, Bordeaux

Site FR33005, La Roche-sur-Yon

Site FR33015, Le Mans

Site FR33012, Lille

Site FR33007, Lyon

Site FR33011, Nîmes

Site FR33001, Pierre-Bénite

Site FR33009, Quimper

Site FR33013, Saint-Mandé

Site DE49002, Freiburg im Breisgau

Site DE49004, Nürtingen

Site IL97201, Kfar Saba

Site IL97211, Ẕerifin

Site IL97210, Beersheba

Site IL97202, Haifa

Site IL97205, Haifa

Site IL97206, Jerusalem

Site IT39005, Meldola

Site IT39004, Cremona

Site IT39003, Milan

Site IT39012, Milan

Site IT39007, Novara

Site IT39008, Pisa

Site IT39006, Padua

Site JP81003, Sakura

Site JP81001, Maebashi

Site JP81013, Kita-gun

Site JP81007, Yokohama

Site JP81016, Sendai

Site JP81010, Abeno-ku

Site JP81011, Chuo-ku

Site JP81012, Sayama

Site JP81006, Bunkyo-ku

Site JP81004, Koto-ku

Site JP81005, Shinjuku-ku

Site JP81017, Ube

Site JP81002, Chiba

Site JP81014, Fukuoka

Site JP81015, Fukuoka

Site JP81008, Kyoto

Site JP81018, Nagasaki

Site JP81020, Niigata

Site JP81019, Yamagata

Site NL31003, Nijmegen

Site NL31007, Nijmegen

Site NL31005, Eindhoven

Site NL31010, Alkmaar

Site NL31008, Amsterdam

Site NL31009, Zwolle

Site NL31002, Sneek

Site NL31006, Rotterdam

Site NZ64003, Tauranga

Site NZ64008, Kensington

Site NZ64002, Dunedin

Site NZ64005, Nelson

Site NZ64004, Hamilton

Site PL48007, Krakow

Site PL48003, Wroclaw

Site PL48011, Warsaw

Site PL48005, Gdansk

Site PL48010, Słupsk

Site PL48001, Mysłowice

Site RO40008, Cluj-Napoca

Site RO40009, Cluj-Napoca

Site RO40002, Floreşti

Site RO40011, Timișoara

Site RO40007, Brasov

Site RO40003, Bucharest

Site RO40006, Bucharest

Site RU70013, Ivanovo

Site RU70001, Moscow

Site RU70003, Moscow

Site RU70014, Moscow

Site RU70006, Omsk

Site RU70005, Penza

Site RU70007, Saint Petersburg

Site RU70008, Saint Petersburg

Site RU70009, Saint Petersburg

Site RU70012, Saint Petersburg

Site RU70016, Saint Petersburg

Site SK42110, Bratislava

Site SK42109, Košice

Site SK42102, Michalovce

Site SK42103, Nitra

Site SK42101, Poprad

Site SK42107, Trenčín

Site KR82008, Seongnam-si

Site KR82007, Busan

Site KR82004, Incheon

Site KR82001, Seoul

Site KR82002, Seoul

Site KR82003, Seoul

Site ES34011, Salamanca

Site ES34010, Sabadell

Site ES34012, Barcelona

Site ES34014, Barcelona

Site ES34006, Pamplona

Site ES34020, Oviedo

Site ES34013, Valencia

Site ES34001, Ávila

Site ES34007, Barcelona

Site ES34004, Madrid

Site ES34019, Madrid

Site SE46002, Örebro

Site SE46001, Malmo

Site SE46006, Stockholm

Site SE46004, Sundsvall

Site SE46007, Gothenburg

Site TW88605, Taipei

Site GB44002, Withington

T6G 1Z2

Site CA15016, Edmonton

V2S 3N6

Site CA15024, Abbotsford

V1W 4V5

Site CA15003, Kelowna

V1Y 5L3

Site CA15022, Kelowna

L6T 4S5

Site CA15010, Brampton

K7L 2V7

Site CA15021, Kingston

L6H 3P1

Site CA15013, Oakville

M5G 2M9

Site CA15020, Toronto

J2G 8Z9

Site CA15023, Granby

H3T1E2

Site CA15004, Montreal

012 07

Site SK42106, Žilina

All Listed Sponsors
collaborator

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

INDUSTRY

lead

Astellas Pharma Global Development, Inc.

INDUSTRY

NCT02677896 - A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) | Biotech Hunter | Biotech Hunter