An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
NCT ID: NCT02257736
Last Updated: 2025-11-12
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
982 participants
INTERVENTIONAL
2014-11-26
2027-12-31
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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Group 1: AAP and apalutamide
Participants will receive apalutamide 240 milligram (mg) (4\*60 mg tablets) and abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily, until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the Open-Label Extension (OLE) or Long-Term Extension (LTE) phase (AAP + open label apalutamide or AAP alone).
Apalutamide
Participants will receive 240 mg (4\*60 mg tablets) of apalutamide once daily orally.
Abiraterone acetate
Participants will receive 1000 mg (4\*250 mg tablets) of abiraterone acetate (AA) once daily orally.
Prednisone
Participants will receive 5 mg tablet of prednisone twice daily orally.
Group 2: AAP and Placebo
Participants will receive matching Placebo of apalutamide and abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the OLE or LTE phase (AAP + open label apalutamide or AAP alone).
Abiraterone acetate
Participants will receive 1000 mg (4\*250 mg tablets) of abiraterone acetate (AA) once daily orally.
Prednisone
Participants will receive 5 mg tablet of prednisone twice daily orally.
Placebo
Participants will receive matching placebo to apalutamide once daily orally.
Interventions
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Apalutamide
Participants will receive 240 mg (4\*60 mg tablets) of apalutamide once daily orally.
Abiraterone acetate
Participants will receive 1000 mg (4\*250 mg tablets) of abiraterone acetate (AA) once daily orally.
Prednisone
Participants will receive 5 mg tablet of prednisone twice daily orally.
Placebo
Participants will receive matching placebo to apalutamide once daily orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). If lymph node metastasis is the only evidence of metastasis, it must be greater than or equal to (\>=) 2 centimeter (cm) in the longest diameter
* Castration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the last androgen deprivation therapy (PSA) \>= 2 nanogram per milliliters (ng/mL)
* Participants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period
* Prostate cancer progression documented by prostate-specific antigen (PSA) according to the Prostate Cancer Clinical Trials Working Group (PCWG2) or radiographic progression of soft tissue according to modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2
* Participants who cross-over from Prednisone alone to open-label apalutamide plus AAP should still be in the double-blind phase of the study, should be receiving AAP alone and should have ECOG 0-1-2.
Exclusion Criteria
* Known brain metastases
* Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting
* Previously treated with ketoconazole for prostate cancer for greater than 7 days
* Therapies that must be discontinued or substituted at least 4 weeks prior to randomization include the following: a) Medications known to lower the seizure threshold, b) Herbal and non-herbal products that may decrease PSA levels (example \[eg\], saw palmetto, pomegranate) or c) Any investigational agent
* At Screening need for parenteral or oral opioid analgesics (eg, codeine, dextropropoxyphene)
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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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Phoenix, Arizona, United States
La Mesa, California, United States
Los Angeles, California, United States
Modesto, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Barbara, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Jensen Beach, Florida, United States
Lakeland, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
Atlanta, Georgia, United States
Melrose, Illinois, United States
Niles, Illinois, United States
Marrero, Louisiana, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Auburn, Maine, United States
Baltimore, Maryland, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Albany, New York, United States
Johnson City, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Columbus, Ohio, United States
Tualatin, Oregon, United States
Lancaster, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Myrtle Beach, South Carolina, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Auburn, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Wenatchee, Washington, United States
Madison, Wisconsin, United States
Ciudad Automoma Buenos Aires, , Argentina
Ciudad de Buenos Aires, , Argentina
Córdoba, , Argentina
La Rioja, , Argentina
Mendoza, , Argentina
Rosario, , Argentina
Adelaide, , Australia
Ashford, , Australia
Camperdown, , Australia
Herston, , Australia
Liverpool, , Australia
Malvern, , Australia
Melbourne, , Australia
Southport, , Australia
Wahroonga, , Australia
West Heidelberg, , Australia
Woolloongabba, , Australia
Antwerp, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Gosselies, , Belgium
Leuven, , Belgium
Liège, , Belgium
Namur, , Belgium
Ottignies, , Belgium
Roeselare, , Belgium
Sint-Niklaas, , Belgium
Barretos, , Brazil
Ijuí, , Brazil
Natal, , Brazil
Porto Alegre, , Brazil
São José do Rio Preto, , Brazil
São Paulo, , Brazil
Abbotsford, British Columbia, Canada
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Halifax, Nova Scotia, Canada
Barrie, Ontario, Canada
London, Ontario, Canada
Oakville, Ontario, Canada
Toronto, Ontario, Canada
Weston, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Angers, , France
Caen, , France
Dijon, , France
Le Mans, , France
Lyon, , France
Montpellier, , France
Paris, , France
Saint-Herblain, , France
Toulouse, , France
Berlin, , Germany
Dresden, , Germany
Freiburg im Breisgau, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Münster, , Germany
Nürtingen, , Germany
Wuppertal, , Germany
Fukuoka, , Japan
Kanazawa, , Japan
Kashiwa, , Japan
Kita-Gun, , Japan
Kumamoto, , Japan
Kurume, , Japan
Matsuyama, , Japan
Miyazaki, , Japan
Nagasaki, , Japan
Osaka, , Japan
Ōsaka-sayama, , Japan
Sakura, , Japan
Sapporo, , Japan
Ube, , Japan
Yokohama, , Japan
Chihuahua City, , Mexico
Cuernavaca, , Mexico
Culiacán, , Mexico
México, , Mexico
Oaxaca City, , Mexico
Zapopan, , Mexico
Amsterdam, , Netherlands
Amsterdam-Zuidoost, , Netherlands
Blaricum, , Netherlands
Dordrecht, , Netherlands
Groningen, , Netherlands
Heerlen, , Netherlands
Nieuwegein, , Netherlands
Nijmegen, , Netherlands
Rotterdam, , Netherlands
The Hague, , Netherlands
Kursk, , Russia
Moscow, , Russia
Omsk, , Russia
Pyatigorsk, , Russia
Rostov-on-Don, , Russia
Saint Petersburg, , Russia
Ufa, , Russia
Bloemfontein, , South Africa
Cape Town, , South Africa
Johannesburg, , South Africa
Pretoria, , South Africa
Goyang-si, , South Korea
Seongnam, , South Korea
Seoul, , South Korea
Alcorcón, , Spain
Barcelona, , Spain
Cadiz, , Spain
Córdoba, , Spain
Madrid, , Spain
San Sebastián de los Reyes, , Spain
Valencia, , Spain
Ayr, , United Kingdom
Belfast, , United Kingdom
Birmingham, , United Kingdom
Edinburgh, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Metropolitan Borough of Wirral, , United Kingdom
Plymouth, , United Kingdom
Preston, , United Kingdom
Stevenage, , United Kingdom
Sutton, , United Kingdom
Westcliff-on-Sea, , United Kingdom
Countries
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References
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Roy S, Wallis CJD, Morgan SC, Kishan AU, Le ATT, Malone J, Sun Y, Spratt DE, Saad F, Malone S. Implications of metastatic stage at presentation in docetaxel naive metastatic castrate resistant prostate cancer. Prostate. 2023 Jul;83(10):912-921. doi: 10.1002/pros.24512. Epub 2023 Apr 18.
Saad F, Efstathiou E, Attard G, Flaig TW, Franke F, Goodman OB Jr, Oudard S, Steuber T, Suzuki H, Wu D, Yeruva K, De Porre P, Brookman-May S, Li S, Li J, Thomas S, Bevans KB, Mundle SD, McCarthy SA, Rathkopf DE; ACIS Investigators. Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 study. Lancet Oncol. 2021 Nov;22(11):1541-1559. doi: 10.1016/S1470-2045(21)00402-2. Epub 2021 Sep 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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56021927PCR3001
Identifier Type: OTHER
Identifier Source: secondary_id
2014-001718-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-508606-26-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR105505
Identifier Type: -
Identifier Source: org_study_id