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A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC
Sponsor: Aragon Pharmaceuticals, Inc.
Summary
The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.
Official title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1052
Start Date
2015-11-27
Completion Date
2027-12-31
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Apalutamide
Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.
Placebo
Participants will receive Placebo orally once daily in each 28 day treatment cycles.
Androgen Deprivation Therapy (ADT)
All participants will receive and remain on a stable regimen of ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration). The choice of the GnRHa (agonist or antagonist) will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.
Locations (222)
Homewood, Alabama, United States
Tucson, Arizona, United States
San Bernardino, California, United States
San Diego, California, United States
Denver, Colorado, United States
Norwalk, Connecticut, United States
Fort Myers, Florida, United States
Chicago, Illinois, United States
Fort Wayne, Indiana, United States
Jeffersonville, Indiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Rockville, Maryland, United States
Lansing, Michigan, United States
Troy, Michigan, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Brooklyn, New York, United States
Poughkeepsie, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Cleveland, Ohio, United States
Middleburg Heights, Ohio, United States
Springfield, Oregon, United States
Bala-Cynwyd, Pennsylvania, United States
Bryn Mawr, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
Burien, Washington, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
Berazategui, Argentina
Buenos Aires, Argentina
C.a.b.a., Argentina
Capital Federal, Argentina
Ciudad Automoma Buenos Aires, Argentina
Ciudad de Buenos Aires, Argentina
Córdoba, Argentina
La Plata, Argentina
Pergamino, Argentina
Rosario, Argentina
San Miguel de Tucumán, Argentina
San Salvador de Jujuy, Argentina
Albury, Australia
Elizabeth Vale, Australia
Kogarah, Australia
Port Macquarie, Australia
South Brisbane, Australia
St Leonards, Australia
Barretos, Brazil
Florianópolis, Brazil
Goiânia, Brazil
Ijuí, Brazil
Natal, Brazil
Ribeirão Preto, Brazil
Rio de Janeiro, Brazil
Salvador, Brazil
Santo André, Brazil
São Paulo, Brazil
Sorocaba, Brazil
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
Toronto, Ontario, Canada
Québec, Quebec, Canada
Beijing, China
Chengdu, China
Chongqing, China
Fuzhou, China
Guangzhou, China
Hangzhou, China
Nanjing, China
Shanghai, China
Suzhou, China
Wuhan, China
Wuxi, China
Xi'an, China
Hradec Králove, Czechia
Liberec, Czechia
Nový Jicin, Czechia
Olomouc, Czechia
Opava, Czechia
Pardubice, Czechia
Prague, Czechia
Zlín, Czechia
Clermont-Ferrand, France
Montpellier, France
Nancy, France
Paris, France
Pierre-Bénite, France
Strasbourg, France
Suresnes, France
Bonn, Germany
Braunschweig, Germany
Eisleben Lutherstadt, Germany
Hamburg, Germany
Hanover, Germany
Leipzig, Germany
Lübeck, Germany
Nürtingen, Germany
Sindelfingen, Germany
Straubing, Germany
Budapest, Hungary
Győr, Hungary
Pécs, Hungary
Sopron, Hungary
Beersheba, Israel
Haifa, Israel
Holon, Israel
Kfar Saba, Israel
Petah Tikva, Israel
Ramat Gan, Israel
Zrifin, Israel
Chūōku, Japan
Hakata-Ku, Japan
Koshigaya, Japan
Matsuyama, Japan
Minamiku, Japan
Miyazaki, Japan
Nagano, Japan
Nagasaki, Japan
Osaka, Japan
Osaka Sayama Shi, Japan
Sakura, Japan
Sapporo, Japan
Yokohama, Japan
Yufu, Japan
Durango, Mexico
Guadalajara, Mexico
León, Mexico
Mexico City, Mexico
México, Mexico
Morelia, Mexico
Zapopan, Mexico
Bialystok, Poland
Bydgoszcz, Poland
Krakow, Poland
Kutno, Poland
Lodz, Poland
Lublin, Poland
Siedlce, Poland
Sochaczew, Poland
Warsaw, Poland
Wroclaw, Poland
Bucharest, Romania
Cluj-Napoca, Romania
Craiova, Romania
Târgu Mureş, Romania
Barnaul, Russia
Ivanovo, Russia
Moscow, Russia
Nizhny Novgorod, Russia
Obninsk, Russia
Omsk, Russia
Pyatigorsk, Russia
Rostov-on-Don, Russia
Ryazan, Russia
Saint Petersburg, Russia
Saransk, Russia
Sochi, Russia
Tambov, Russia
Tomsk, Russia
Tyumen, Russia
Ufa, Russia
Vologda, Russia
Daegu, South Korea
Daejeon, South Korea
Goyang-si, South Korea
Jeollanam-do, South Korea
Seongnam-si, South Korea
Seoul, South Korea
Barcelona, Spain
Córdoba, Spain
Jerez de la Frontera, Spain
Madrid, Spain
Pamplona, Spain
Gothenburg, Sweden
Malmo, Sweden
Örebro, Sweden
Stockholm, Sweden
Umeå, Sweden
Uppsala, Sweden
Vaxjo, Sweden
Ankara, Turkey (Türkiye)
Edirne, Turkey (Türkiye)
Istanbul, Turkey (Türkiye)
Izmir, Turkey (Türkiye)
Mersin, Turkey (Türkiye)
Cherkasy, Ukraine
Dnipo, Ukraine
Dnipro, Ukraine
Ivano-Frankivsk, Ukraine
Khakhiv, Ukraine
Kharkiv, Ukraine
Khmelnytsky, Ukraine
Kyiv, Ukraine
Lviv, Ukraine
Odesa, Ukraine
Poltava, Ukraine
Uzhhorod, Ukraine
Vinnitsa, Ukraine
Zaporizhzhya, Ukraine
Carlisle, United Kingdom
Dundee, United Kingdom
Glasgow, United Kingdom
London, United Kingdom
Newcastle upon Tyne, United Kingdom
Oxford, United Kingdom
Plymouth, United Kingdom
Scunthorpe, United Kingdom
Stockton-on-Tees, United Kingdom
Wolverhampton, United Kingdom