An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
NCT ID: NCT02531516
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1503 participants
INTERVENTIONAL
2015-11-19
2028-12-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Apalutamide
Participants will receive apalutamide (240 mg), by mouth, once daily for overall 30 months, plus bicalutamide placebo, by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.
Apalutamide
Bicalutamide Placebo
GnRH (agonist)
74-80 Grays (units of radiation)
Control group
Participants will receive apalutamide placebo, by mouth, once daily for overall 30 months, plus bicalutamide (50 mg), by mouth, once daily, for four months from randomization. All participants are treated with gonadotropin releasing hormone (GnRH) agonist for 30 months from randomization and radiation therapy to the prostate started at about 8 weeks after randomization.
Bicalutamide
Apalutamide Placebo
GnRH (agonist)
74-80 Grays (units of radiation)
Interventions
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Apalutamide
Bicalutamide
Bicalutamide Placebo
Apalutamide Placebo
GnRH (agonist)
74-80 Grays (units of radiation)
Eligibility Criteria
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Inclusion Criteria
* Indicated and planned to receive primary radiation therapy for prostate cancer
* Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis: 1) Gleason score \>=8 and \>=cT2c, 2) Gleason score 7, PSA \>=20 nanogram per milliliters (ng/mL), and \>=cT2c
* Charlson index (CCI) \<=3
* An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1
* Adequate organ function: (1) aspartate aminotransferase (AST), alanine aminotransferase (ALT), within normal limits (WNL), (2) serum creatinine less than (\<) 1.5 milligram/deciliter (mg/dL) (\<133 micromoles/Liter \[mcmol/L\]), (3) platelets greater than or equal to (\>=)140,000/microLiter (mcL), independent of transfusion and/or growth factors within 3 months prior to randomization, (4) Hemoglobin \>= 12.0 gram/deciliter (g/dL) (7.4 millimloes \[mmol\], independent of transfusion and/or growth factors within 3 months prior to randomization
* Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial
* Signed, written, informed consent
* Be able to swallow whole study drug tablets
Exclusion Criteria
* Prior treatment with gonadotropin releasing hormone (GnRH) analogue or anti-androgen or both for \>3 months prior to randomization
* Bilateral orchiectomy
* History of pelvic radiation
* Prior systemic (example \[e.g.\], chemotherapy) or local (e.g. radical prostatectomy, cryotherapy) treatment for prostate cancer
* History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness \<= 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
* Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents (including cyproterone acetate) for prostate cancer
* Prior treatment with radiopharmaceutical agents (e.g., strontium-89) or immunotherapy (e.g., sipuleucel-T) for prostate cancer
* Prior treatment with systemic glucocorticoids ≤4 weeks prior to randomization or is expected to require long-term use of corticosteroids during the study
* Use of 5-alpha reductase inhibitors (e.g., dutasteride, finasteride) \<=4 weeks prior to randomization
* Use of any investigational agent \<=4 weeks prior to randomization
* Current chronic use of opioid analgesics for \>=3 weeks for oral or \>= 7 days for non-oral formulations
* Major surgery \<=4 weeks prior to randomization
* Current or prior treatment with anti-epileptic medications for the treatment of seizures
* Gastrointestinal conditions affecting absorption
* Known or suspected contraindications or hypersensitivity to apalutamide, bicalutamide or GnRH agonists or any of the components of the formulations
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject
18 Years
MALE
No
Sponsors
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Aragon Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Aragon Pharmaceuticals, Inc. Clinical Trial
Role: STUDY_DIRECTOR
Aragon Pharmaceuticals, Inc.
Locations
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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, , 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
Daegu, , South Korea
Gyeonggi-do, , South Korea
Jeollanam-do, , South Korea
Seoul, , 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
Countries
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References
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Poterala JE, Wisinski KB. Abbreviated endocrine therapy duration for low estrogen receptor-positive breast cancer: The counter to extended endocrine therapy. Cancer. 2022 May 1;128(9):1724-1726. doi: 10.1002/cncr.34158. Epub 2022 Feb 25. No abstract available.
Other Identifiers
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56021927PCR3003
Identifier Type: OTHER
Identifier Source: secondary_id
2015-003007-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-505246-26-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR106935
Identifier Type: -
Identifier Source: org_study_id