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An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
Sponsor: Aragon Pharmaceuticals, Inc.
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
Conditions
Interventions
Apalutamide
Bicalutamide
Bicalutamide Placebo
Apalutamide Placebo
GnRH (agonist)
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