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ACTIVE NOT RECRUITING
NCT02531516
PHASE3

An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS

Sponsor: Aragon Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival (MFS) based on conventional imaging assessed by blinded independent central review (BICR).

Official title: ATLAS: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment With Primary Radiation Therapy

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1503

Start Date

2015-11-19

Completion Date

2028-12-29

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DRUG

Apalutamide

DRUG

Bicalutamide

DRUG

Bicalutamide Placebo

DRUG

Apalutamide Placebo

DRUG

GnRH (agonist)

RADIATION

74-80 Grays (units of radiation)

Locations (263)

Homewood, Alabama, United States

Chandler, Arizona, United States

Scottsdale, Arizona, United States

Tucson, Arizona, United States

Bakersfield, California, United States

Los Angeles, California, United States

Orange, California, United States

San Bernardino, California, United States

San Diego, California, United States

San Francisco, California, United States

Aurora, Colorado, United States

Denver, Colorado, United States

Middlebury, Connecticut, United States

Bradenton, Florida, United States

Daytona Beach, Florida, United States

Fort Myers, Florida, United States

Hialeah, Florida, United States

Lakewood Rch, Florida, United States

Naples, Florida, United States

Plantation, Florida, United States

Meridian, Idaho, United States

Evergreen Park, Illinois, United States

Harvey, Illinois, United States

Jeffersonville, Indiana, United States

Wichita, Kansas, United States

Ashland, Kentucky, United States

New Orleans, Louisiana, United States

Shreveport, Louisiana, United States

Scarborough, Maine, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

St Louis, Missouri, United States

Morristown, New Jersey, United States

Albany, New York, United States

Brooklyn, New York, United States

New York, New York, United States

Poughkeepsie, New York, United States

Rochester, New York, United States

Syracuse, New York, United States

The Bronx, New York, United States

Cary, North Carolina, United States

Raleigh, North Carolina, United States

Portland, Oregon, United States

Springfield, Oregon, United States

Bala-Cynwyd, Pennsylvania, United States

Bryn Mawr, Pennsylvania, United States

Lancaster, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

East Greenwich, Rhode Island, United States

Charleston, South Carolina, United States

Myrtle Beach, South Carolina, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Fairfax, Virginia, United States

Virginia Beach, Virginia, United States

Burien, Washington, United States

Spokane, Washington, United States

Morgantown, West Virginia, United States

Buenos Aires, Argentina

C.a.b.a., Argentina

Caba, Argentina

Pergamino, Argentina

Rosario, Argentina

San Salvador de Jujuy, Argentina

Aalst, Belgium

Antwerp, Belgium

Bonheiden, Belgium

Brussels, Belgium

Haine-St-Paul, Belgium

Leuven, Belgium

Liège, Belgium

Namur, Belgium

Roeselare, Belgium

Sint-Niklaas, Belgium

Turnhout, Belgium

Barretos, Brazil

Belo Horizonte, Brazil

Campinas, Brazil

Curitiba, Brazil

Florianópolis, Brazil

Goiânia, Brazil

Ijuí, Brazil

Natal, Brazil

Porto Alegre, Brazil

Ribeirão Preto, Brazil

Rio de Janeiro, Brazil

Salvador, Brazil

Santo André, Brazil

São José do Rio Preto, Brazil

São Paulo, Brazil

Sorocaba, Brazil

Calgary, Alberta, Canada

Surrey, British Columbia, Canada

Vancouver, British Columbia, Canada

Victoria, British Columbia, Canada

London, Ontario, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Gatineau, Quebec, Canada

Laval, Quebec, Canada

Montreal, Quebec, Canada

Québec, Quebec, Canada

Sherbrooke, Quebec, Canada

Beijing, China

Chengdu, China

Chongqing, China

Guangzhou, China

Hangzhou, China

Nanchang, China

Nanjing, China

Ningbo, China

Shanghai, China

Wuhan, China

Xi'an, China

Hradec Králove, Czechia

Liberec, Czechia

Nový Jicin, Czechia

Olomouc, Czechia

Opava, Czechia

Pardubice, Czechia

Prague, Czechia

Zlín, Czechia

Amiens, France

Angers, France

Avignon, France

Bayonne, France

Besançon, France

Bordeaux, France

Brest, France

Dijon, France

Évry-Courcouronnes, France

Hyères, France

La Tronche, France

Le Mans, France

Lille, France

Marseille, France

Marseilli, France

Montpellier, France

Neuilly-sur-Seine, France

Paris, France

Ris-Orangis, France

Saint-Brieuc, France

Saint-Herblain, France

Saint-Mandé, France

Saint-Priest-en-Jarez, France

Strasbourg, France

Toulouse, France

Tours, France

Vandœuvre-lès-Nancy, France

Villejuif, France

Braunschweig, Germany

Chemnitz, Germany

Dessau, Germany

Frankfurt, Germany

Gronau, Germany

Jena, Germany

Münster, Germany

Nürtingen, Germany

Ulm, Germany

Weiden/Opf, Germany

Beer Yaakov, Israel

Beersheba, Israel

Haifa, Israel

Jerusalem, Israel

Kfar Saba, Israel

Petah Tikva, Israel

Ramat Gan, Israel

Tel Aviv, Israel

George Town, Malaysia

Kuala Lumpur, Malaysia

Kuching, Malaysia

Putrajaya, Malaysia

Culiacán, Mexico

Guadalajara, Mexico

León, Mexico

México, Mexico

Morelia, Mexico

Zapopan, Mexico

Alkmaar, Netherlands

Amsterdam, Netherlands

Nijmegen, Netherlands

Rotterdam, Netherlands

The Hague, Netherlands

Bialystok, Poland

Bydgoszcz, Poland

Gdynia, Poland

Gliwice, Poland

Kielce, Poland

Lodz, Poland

Olsztyn, Poland

Poznan, Poland

Wałbrzych, Poland

Bucharest, Romania

Cluj-Napoca, Romania

Floreşti, Romania

Iași, Romania

Otopeni, Romania

Ploieşti, Romania

Sibiu, Romania

Târgu Mureş, Romania

Timișoara, 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

Tambov, Russia

Tyumen, Russia

Ufa, Russia

Vologda, Russia

Buk Gu, South Korea

Gyeonggi-do, South Korea

Jeollanam-do, South Korea

Seoul, South Korea

Suwon, South Korea

Barakaldo, Spain

Barcelona, Spain

Castellon, Spain

L'Hospitalet de Llobregat, Spain

Las Palmas de Gran Canaria, Spain

Madrid, Spain

Málaga, Spain

Reus, Spain

Santiago de Compostela, Spain

Seville, Spain

Örebro, Sweden

Stockholm, Sweden

Umeå, Sweden

Kaohsiung City, Taiwan

Taichung, Taiwan

Tainan, Taiwan

Taipei, Taiwan

Taoyuan District, Taiwan

Adana, Turkey (Türkiye)

Ankara, Turkey (Türkiye)

Edirne, Turkey (Türkiye)

Istanbul, Turkey (Türkiye)

Izmir, Turkey (Türkiye)

Kayseri, Turkey (Türkiye)

Kocaeli, Turkey (Türkiye)

Dnipro, Ukraine

Khakhiv, Ukraine

Kyiv, Ukraine

Lviv, Ukraine

Aberdeen, United Kingdom

Birmingham, United Kingdom

Bristol, United Kingdom

Derby, United Kingdom

Glasgow, United Kingdom

Oxford, United Kingdom

Plymouth, United Kingdom

Preston, United Kingdom

Sheffield, United Kingdom

Sutton, United Kingdom

Wolverhampton, United Kingdom