A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC
NCT ID: NCT02489318
Last Updated: 2025-11-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
1052 participants
INTERVENTIONAL
2015-11-27
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Apalutamide plus ADT
Participants will receive apalutamide 240 milligram (mg) (4X 60 mg tablets) with ADT.
Apalutamide
Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.
Androgen Deprivation Therapy (ADT)
All participants will receive and remain on a stable regimen of ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration). The choice of the GnRHa (agonist or antagonist) will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.
Placebo plus ADT
Participants will receive matching Placebo with ADT.
Placebo
Participants will receive Placebo orally once daily in each 28 day treatment cycles.
Androgen Deprivation Therapy (ADT)
All participants will receive and remain on a stable regimen of ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration). The choice of the GnRHa (agonist or antagonist) will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Apalutamide
Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.
Placebo
Participants will receive Placebo orally once daily in each 28 day treatment cycles.
Androgen Deprivation Therapy (ADT)
All participants will receive and remain on a stable regimen of ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration). The choice of the GnRHa (agonist or antagonist) will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Metastatic disease documented by greater than or equal to (\>=) 1 bone lesions on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by computed tomography (CT) or magnetic resonance imaging (MRI)
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1
* Participants who received docetaxel treatment must meet the following criteria: a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC; b) Received the last dose of docetaxel \<=2 months prior to randomization; c) Maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization
* Other allowed prior treatment for mHSPC: a) Maximum of 1 course of radiation or surgical intervention; radiation therapy for metastatic lesions must be completed prior to randomization; b) Less than or equal to (\<=) 6 months of ADT prior to randomization
* Allowed prior treatments for localized prostate cancer (all treatments must have been completed \>= 1 year prior to randomization) a) \<= 3 years total of ADT; b) All other forms of prior therapies including radiation therapy, prostatectomy,lymph node dissection, and systemic therapies
Exclusion Criteria
* Known brain metastases
* Lymph nodes as only sites of metastases
* Visceral (ie, liver or lung) metastases as only sites of metastases
* Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer
* Prior treatment with other next generation anti-androgens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer
* History of seizures or medications known to lower seizure threshold
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aragon Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Homewood, Alabama, United States
Tucson, Arizona, United States
San Bernardino, California, United States
San Diego, California, United States
Denver, Colorado, United States
Norwalk, Connecticut, United States
Fort Myers, Florida, United States
Chicago, Illinois, United States
Fort Wayne, Indiana, United States
Jeffersonville, Indiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Rockville, Maryland, United States
Lansing, Michigan, United States
Troy, Michigan, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Brooklyn, New York, United States
Poughkeepsie, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Cleveland, Ohio, United States
Middleburg Heights, Ohio, United States
Springfield, Oregon, United States
Bala-Cynwyd, Pennsylvania, United States
Bryn Mawr, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
Burien, Washington, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
Berazategui, , Argentina
Buenos Aires, , Argentina
C.a.b.a., , Argentina
Capital Federal, , Argentina
Ciudad Automoma Buenos Aires, , Argentina
Ciudad de Buenos Aires, , Argentina
Córdoba, , Argentina
La Plata, , Argentina
Pergamino, , Argentina
Rosario, , Argentina
San Miguel de Tucumán, , Argentina
San Salvador de Jujuy, , Argentina
Albury, , Australia
Elizabeth Vale, , Australia
Kogarah, , Australia
Port Macquarie, , Australia
South Brisbane, , Australia
St Leonards, , Australia
Barretos, , Brazil
Florianópolis, , Brazil
Goiânia, , Brazil
Ijuí, , Brazil
Natal, , Brazil
Ribeirão Preto, , Brazil
Rio de Janeiro, , Brazil
Salvador, , Brazil
Santo André, , Brazil
São Paulo, , Brazil
Sorocaba, , Brazil
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
Toronto, Ontario, Canada
Québec, Quebec, Canada
Beijing, , China
Chengdu, , China
Chongqing, , China
Fuzhou, , China
Guangzhou, , China
Hangzhou, , China
Nanjing, , China
Shanghai, , China
Suzhou, , China
Wuhan, , China
Wuxi, , China
Xi'an, , China
Hradec Králove, , Czechia
Liberec, , Czechia
Nový Jicin, , Czechia
Olomouc, , Czechia
Opava, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Zlín, , Czechia
Clermont-Ferrand, , France
Montpellier, , France
Nancy, , France
Paris, , France
Pierre-Bénite, , France
Strasbourg, , France
Suresnes, , France
Bonn, , Germany
Braunschweig, , Germany
Eisleben Lutherstadt, , Germany
Hamburg, , Germany
Hanover, , Germany
Leipzig, , Germany
Lübeck, , Germany
Nürtingen, , Germany
Sindelfingen, , Germany
Straubing, , Germany
Budapest, , Hungary
Győr, , Hungary
Pécs, , Hungary
Sopron, , Hungary
Beersheba, , Israel
Haifa, , Israel
Holon, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Zrifin, , Israel
Chūōku, , Japan
Hakata-Ku, , Japan
Koshigaya, , Japan
Matsuyama, , Japan
Minamiku, , Japan
Miyazaki, , Japan
Nagano, , Japan
Nagasaki, , Japan
Osaka, , Japan
Osaka Sayama Shi, , Japan
Sakura, , Japan
Sapporo, , Japan
Yokohama, , Japan
Yufu, , Japan
Durango, , Mexico
Guadalajara, , Mexico
León, , Mexico
Mexico City, , Mexico
México, , Mexico
Morelia, , Mexico
Zapopan, , Mexico
Bialystok, , Poland
Bydgoszcz, , Poland
Krakow, , Poland
Kutno, , Poland
Lodz, , Poland
Lublin, , Poland
Siedlce, , Poland
Sochaczew, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Bucharest, , Romania
Cluj-Napoca, , Romania
Craiova, , Romania
Târgu Mureş, , 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
Sochi, , Russia
Tambov, , Russia
Tomsk, , Russia
Tyumen, , Russia
Ufa, , Russia
Vologda, , Russia
Daegu, , South Korea
Daejeon, , South Korea
Goyang-si, , South Korea
Jeollanam-do, , South Korea
Seongnam-si, , South Korea
Seoul, , South Korea
Barcelona, , Spain
Córdoba, , Spain
Jerez de la Frontera, , Spain
Madrid, , Spain
Pamplona, , Spain
Gothenburg, , Sweden
Malmo, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Umeå, , Sweden
Uppsala, , Sweden
Vaxjo, , Sweden
Ankara, , Turkey (Türkiye)
Edirne, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Mersin, , Turkey (Türkiye)
Cherkasy, , Ukraine
Dnipo, , Ukraine
Dnipro, , Ukraine
Ivano-Frankivsk, , Ukraine
Khakhiv, , Ukraine
Kharkiv, , Ukraine
Khmelnytsky, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Poltava, , Ukraine
Uzhhorod, , Ukraine
Vinnitsa, , Ukraine
Zaporizhzhya, , Ukraine
Carlisle, , United Kingdom
Dundee, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Oxford, , United Kingdom
Plymouth, , United Kingdom
Scunthorpe, , United Kingdom
Stockton-on-Tees, , United Kingdom
Wolverhampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Karsh LI, Bevans KB, Saad F, Chung BH, Oudard S, Brookman-May SD, McCarthy SA, Smith MR, Chi KN, Small EJ, Agarwal N. Prostate-specific antigen and health-related quality of life in individuals with advanced prostate cancer treated with apalutamide: a plain language summary of the SPARTAN and TITAN studies. Future Oncol. 2024;20(35):2689-2698. doi: 10.1080/14796694.2024.2384257. Epub 2024 Aug 20.
Merseburger AS, Agarwal N, Bjartell A, Uemura H, Soto AJ, Bhaumik A, Bohm J, Tran N, Krochmann N, Nematian-Samani M, Mundle SD, Brookman-May SD, Lopez-Gitlitz A, McCarthy SA, Chi K, Chowdhury S. Targeted Investigational Treatment Analysis of Novel Anti-androgen (TITAN) study: ultralow prostate-specific antigen decline with apalutamide plus androgen-deprivation therapy. BJU Int. 2024 Dec;134(6):982-991. doi: 10.1111/bju.16449. Epub 2024 Jun 28.
Shen J, Chowdhury S, Agarwal N, Karsh LI, Oudard S, Gartrell BA, Feyerabend S, Saad F, Pieczonka CM, Chi KN, Brookman-May SD, Rooney B, Bhaumik A, McCarthy SA, Bevans KB, Mundle SD, Small EJ, Smith MR, Graff JN. Apalutamide efficacy, safety and wellbeing in older patients with advanced prostate cancer from Phase 3 randomised clinical studies TITAN and SPARTAN. Br J Cancer. 2024 Jan;130(1):73-81. doi: 10.1038/s41416-023-02492-8. Epub 2023 Nov 11.
Merseburger AS, Agarwal N, Bhaumik A, Lefresne F, Karsh LI, Pereira de Santana Gomes AJ, Soto AJ, Given RW, Brookman-May SD, Mundle SD, McCarthy SA, Uemura H, Chowdhury S, Chi KN, Bjartell A. Apalutamide plus androgen deprivation therapy in clinical subgroups of patients with metastatic castration-sensitive prostate cancer: A subgroup analysis of the randomised clinical TITAN study. Eur J Cancer. 2023 Nov;193:113290. doi: 10.1016/j.ejca.2023.113290. Epub 2023 Aug 11.
Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, Ozguroglu M, Juarez Soto A, Merseburger AS, Uemura H, Ye D, Given R, Basch E, Miladinovic B, Lopez-Gitlitz A, Chi KN. Apalutamide plus Androgen Deprivation Therapy for Metastatic Castration-Sensitive Prostate Cancer: Analysis of Pain and Fatigue in the Phase 3 TITAN Study. J Urol. 2021 Oct;206(4):914-923. doi: 10.1097/JU.0000000000001841. Epub 2021 May 27.
Chi KN, Chowdhury S, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juarez A, Merseburger AS, Ozguroglu M, Uemura H, Ye D, Brookman-May S, Mundle SD, McCarthy SA, Larsen JS, Sun W, Bevans KB, Zhang K, Bandyopadhyay N, Agarwal N. Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study. J Clin Oncol. 2021 Jul 10;39(20):2294-2303. doi: 10.1200/JCO.20.03488. Epub 2021 Apr 29.
Uemura H, Koroki Y, Iwaki Y, Imanaka K, Kambara T, Lopez-Gitlitz A, Smith A, Uemura H. Skin rash following Administration of Apalutamide in Japanese patients with Advanced Prostate Cancer: an integrated analysis of the phase 3 SPARTAN and TITAN studies and a phase 1 open-label study. BMC Urol. 2020 Sep 2;20(1):139. doi: 10.1186/s12894-020-00689-0.
Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, Ozguroglu M, Juarez Soto A, Merseburger AS, Uemura H, Ye D, Given R, Cella D, Basch E, Miladinovic B, Dearden L, Deprince K, Naini V, Lopez-Gitlitz A, Chi KN; TITAN investigators. Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2019 Nov;20(11):1518-1530. doi: 10.1016/S1470-2045(19)30620-5. Epub 2019 Sep 29.
Chi KN, Agarwal N, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juarez Soto A, Merseburger AS, Ozguroglu M, Uemura H, Ye D, Deprince K, Naini V, Li J, Cheng S, Yu MK, Zhang K, Larsen JS, McCarthy S, Chowdhury S; TITAN Investigators. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2019 Jul 4;381(1):13-24. doi: 10.1056/NEJMoa1903307. Epub 2019 May 31.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
56021927PCR3002
Identifier Type: OTHER
Identifier Source: secondary_id
2015-000735-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR107614
Identifier Type: -
Identifier Source: org_study_id