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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

2026-11-03

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 Saint Paul La Louviere, 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

And 163 more locations on ClinicalTrials.gov