Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
ARAMIS
A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
2 other identifiers
interventional
1,509
32 countries
388
Brief Summary
The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2014
Longer than P75 for phase_3
388 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2014
CompletedFirst Posted
Study publicly available on registry
July 25, 2014
CompletedStudy Start
First participant enrolled
September 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2018
CompletedResults Posted
Study results publicly available
October 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2021
CompletedJune 28, 2022
June 1, 2022
4 years
July 22, 2014
August 30, 2019
June 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Metastasis-Free Survival
Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first (cut-off date 15 Nov 2019)
From randomization to the time approximately 385 MFS events were observed (approximately 48 months)
Secondary Outcomes (8)
Overall Survival - Primary Analysis
From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 months)
Time to Pain Progression - Primary Analysis
From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Primary Analysis
From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
Time to First Symptomatic Skeletal Event (SSE) - Primary Analysis
From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
Overall Survival - Final Analysis
From randomization of the first subject to the time approximatively 254 death events were observed (approximately 56 months)
- +3 more secondary outcomes
Study Arms (2)
Darolutamide (BAY1841788)
EXPERIMENTALParticipants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.
Placebo
PLACEBO COMPARATORParticipants received matching placebo 2 tablets twice daily with food.
Interventions
Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features.
- Castration-resistant prostate cancer (CRPC) with castrate level of serum testosterone.
- Prostate-specific Antigen (PSA) doubling time of ≤ 10 months and PSA \> 2ng/ml.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Blood counts at screening: haemoglobin ≥ 9.0 g/dl,absolute neutrophil count ≥ 1500/µl, platelet count ≥ 100,000/µl.
- Screening values of serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, creatinine ≤ 2.0 x ULN.
- Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment.
You may not qualify if:
- History of metastatic disease at any time or presence of detectable metastases.
- Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation.
- Prior treatment with: second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor.
- Use of estrogens or 5-α reductase inhibitors or AR inhibitors.
- Prior chemotherapy or immunotherapy for prostate cancer.
- Use of systemic corticosteroid.
- Radiation therapy within 12 weeks before randomisation.
- Severe or uncontrolled concurrent disease, infection or co-morbidity.
- Treatment with bisphosphonate or denosumab within 12 weeks before randomisation.
- Known hypersensitivity to the study treatment or any of its ingredients.
- Major surgery within 28 days before randomisation.
- Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV.
- Uncontrolled hypertension.
- Prior malignancy.
- Gastrointestinal disorder or procedure which expects to interfere significantly with absorption of study treatment.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Orion Corporation, Orion Pharmacollaborator
Study Sites (404)
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Homewood, Alabama, 35209, United States
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Anchorage, Alaska, 99503, United States
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Tucson, Arizona, 85704, United States
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Fountain Valley, California, 92708, United States
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La Jolla, California, 92093, United States
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Laguna Hills, California, 92653, United States
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Los Angeles, California, 90048, United States
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Los Angeles, California, 90073-1003, United States
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San Diego, California, 92120, United States
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Whittier, California, 90603, United States
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Denver, Colorado, 80211, United States
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Denver, Colorado, 80220, United States
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Parker, Colorado, 80134, United States
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Boca Raton, Florida, 33486, United States
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Orlando, Florida, 32803, United States
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Port Saint Lucie, Florida, 34952, United States
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Coeur d'Alene, Idaho, 83814, United States
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Chicago, Illinois, 60612, United States
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Evanston, Illinois, 60201-1613, United States
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Springfield, Illinois, 62702, United States
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Greenwood, Indiana, 46143, United States
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Indianapolis, Indiana, 46202, United States
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Jeffersonville, Indiana, 47130, United States
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West Des Moines, Iowa, 50266, United States
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Wichita, Kansas, 67226, United States
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New Orleans, Louisiana, 70121, United States
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Annapolis, Maryland, 21401, United States
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Baltimore, Maryland, 21204, United States
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Salisbury, Maryland, 21801, United States
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Boston, Massachusetts, 02114, United States
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Grand Rapids, Michigan, 49546, United States
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Royal Oak, Michigan, 48073, United States
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Omaha, Nebraska, 68114, United States
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Omaha, Nebraska, 68130, United States
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Lebanon, New Hampshire, 03756-1000, United States
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Voorhees Township, New Jersey, 08043, United States
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Syracuse, New York, 13210, United States
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The Bronx, New York, 10461, United States
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The Bronx, New York, 10469, United States
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Asheboro, North Carolina, 27203, United States
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Charlotte, North Carolina, 28277, United States
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Canton, Ohio, 44718, United States
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Cincinnati, Ohio, 45212, United States
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Cleveland, Ohio, 44195, United States
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Gahanna, Ohio, 43230, United States
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Middleburg Heights, Ohio, 44130, United States
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Oklahoma City, Oklahoma, 73104, United States
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Bala-Cynwyd, Pennsylvania, 19004, United States
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Myrtle Beach, South Carolina, 29572, United States
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Nashville, Tennessee, 37209, United States
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Dallas, Texas, 75231, United States
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Fairfax, Virginia, 22031, United States
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Richmond, Virginia, 23235, United States
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Virginia Beach, Virginia, 23462, United States
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Wheeling, West Virginia, 26003, United States
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Buenos Aires, Ciudad Auton. de Buenos Aires, C1120AAT, Argentina
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Santa Fé, Santa Fe Province, S3000FFV, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000HXU, Argentina
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Córdoba, X5000HXL, Argentina
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Córdoba, X5004FHP, Argentina
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Córdoba, X5016KEH, Argentina
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La Rioja, F5300COE, Argentina
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Randwick, New South Wales, 2031, Australia
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St Leonards, New South Wales, 2065, Australia
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Douglas, Queensland, 4814, Australia
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South Brisbane, Queensland, 4101, Australia
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Kurralta Park, South Australia, 5037, Australia
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Fitzroy, Victoria, 3065, Australia
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Vienna, 1020, Austria
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Vienna, 1090, Austria
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Lesnoy, 223040, Belarus
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Minsk, 220013, Belarus
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Bonheiden, 2820, Belgium
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Kortrijk, 8500, Belgium
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Libramont, 6800, Belgium
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Liège, 4000, Belgium
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Sint-Truiden, 3800, Belgium
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Fortaleza, Ceará, 60430-230, Brazil
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Salvador, Estado de Bahia, 40050-001, Brazil
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Goiânia, Goiás, 74605-070, Brazil
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Belo Horizonte, Minas Gerais, 30150-320, Brazil
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Juiz de Fora, Minas Gerais, 36010-510, Brazil
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Uberlândia, Minas Gerais, 38408-150, Brazil
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Curitiba, Paraná, 81520-060, Brazil
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Recife, Pernambuco, 50070-550, Brazil
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Passo Fundo, Rio Grande do Sul, 99010-080, Brazil
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Porto Alegre, Rio Grande do Sul, 90050 170, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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Itajaí, Santa Catarina, 88301-220, Brazil
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Barretos, São Paulo, 14784-400, Brazil
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Jaú, São Paulo, 17210-080, Brazil
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Ribeirao Preto - SP, São Paulo, 14048-900, Brazil
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São Paulo, São Paulo, 01209-000, Brazil
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São Paulo, São Paulo, 01236-030, Brazil
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São Paulo, São Paulo, 01246-000, Brazil
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São Paulo, São Paulo, 04014-002, Brazil
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São Paulo, São Paulo, 04039-004, Brazil
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Sorocaba, São Paulo, 18035-300, Brazil
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Sofia, 1680, Bulgaria
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Varna, 9000, Bulgaria
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Calgary, Alberta, T2V 1P9, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Hamilton, Ontario, L8N 4A6, Canada
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Kingston, Ontario, K7L 3J7, Canada
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London, Ontario, N6A 5W9, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Granby, Quebec, J2G 8Z9, Canada
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Pointe-Claire, Quebec, H9R 4S3, Canada
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Medellín, Antioquia, 050034, Colombia
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Montería, Departamento de Córdoba, 230002, Colombia
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Floridablanca, Santander Department, 681004, Colombia
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Jablonec nad Nisou, 466 60, Czechia
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Kolín, 280 00, Czechia
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Olomouc, 775 20, Czechia
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Opava, 746 01, Czechia
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Prague, 120 00, Czechia
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Prague, 128 08, Czechia
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Prague, 160 00, Czechia
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Prague, 180 81, Czechia
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Tallinn, 13419, Estonia
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Helsinki, 00290, Finland
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Kuopio, 70210, Finland
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Seinäjoki, 60220, Finland
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Tampere, 33521, Finland
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Turku, FIN-20521, Finland
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Angers, 49100, France
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Bayonne, 64100, France
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Besançon, 25030, France
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Bordeaux, 33076, France
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Caen, 14076, France
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Cergy-Pontoise, 95303, France
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Clermont-Ferrand, 63011, France
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Créteil, 94010, France
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Dijon, 21000, France
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La Roche-sur-Yon, 85925, France
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Limoges, 87042, France
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Montpellier, 34295, France
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Montpellier, 34298, France
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Nancy, 54100, France
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Nantes, 44093, France
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Paris, 75010, France
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Paris, 75014, France
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Pierre-Bénite, 69495, France
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Poitiers, 86021, France
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Reims, 51726, France
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Rennes, 35033, France
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Rouen, 76031, France
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Saint-Mandé, 94160, France
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Strasbourg, 67000, France
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Suresnes, 92151, France
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Tours, 37044, France
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Villejuif, 94805, France
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Emmendingen, Baden-Wurttemberg, 79312, Germany
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Kirchheim unter Teck, Baden-Wurttemberg, 73230, Germany
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Mühlacker, Baden-Wurttemberg, 75417, Germany
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Nürtingen, Baden-Wurttemberg, 72622, Germany
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Reutlingen, Baden-Wurttemberg, 72764, Germany
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Tübingen, Baden-Wurttemberg, 72076, Germany
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Zirndorf, Bavaria, 90513, Germany
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Frankfurt am Main, Hesse, 60590, Germany
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Marburg, Hesse, 35039, Germany
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Herzberg am Harz, Lower Saxony, 37412, Germany
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Holzminden, Lower Saxony, 37603, Germany
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Hagenow, Mecklenburg-Vorpommern, 19230, Germany
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Cologne, North Rhine-Westphalia, 50937, Germany
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Düsseldorf, North Rhine-Westphalia, 40225, Germany
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Mülheim, North Rhine-Westphalia, 45468, Germany
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Münster, North Rhine-Westphalia, 48149, Germany
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Wuppertal, North Rhine-Westphalia, 42103, Germany
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Mainz, Rhineland-Palatinate, 55131, Germany
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Dresden, Saxony, 01307, Germany
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Magdeburg, Saxony-Anhalt, 39120, Germany
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Berlin, 12203, Germany
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Hamburg, 20246, Germany
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Hamburg, 22081, Germany
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Budapest, 1086, Hungary
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Budapest, 1145, Hungary
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Budapest, 1204, Hungary
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Debrecen, 4032, Hungary
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Győr, 9023, Hungary
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Nyíregyháza, 4400, Hungary
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Szeged, 6725, Hungary
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Szekszárd, 7100, Hungary
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Szolnok, 5000, Hungary
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Zalaegerszeg, 8900, Hungary
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Haifa, 35152, Israel
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Chieti, Abruzzo, 66100, Italy
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Lecce, Apulia, 73100, Italy
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Catanzaro, Calabria, 88100, Italy
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Napoli, Campania, 80131, Italy
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Forlì Cesena, Emilia-Romagna, 47014, Italy
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Modena, Emilia-Romagna, 41124, Italy
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Parma, Emilia-Romagna, 43126, Italy
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Rome, Lazio, 00144, Italy
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Rome, Lazio, 00189, Italy
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Turin, Piedmont, 10043, Italy
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Turin, Piedmont, 10060, Italy
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Messina, Sicily, 98125, Italy
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Palermo, Sicily, 90127, Italy
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Arezzo, Tuscany, 52100, Italy
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Nagoya, Aichi-ken, 466-8560, Japan
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Kashiwa, Chiba, 277-8577, Japan
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Kurume, Fukuoka, 839-0863, Japan
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Kōriyama, Fukushima, 963-8052, Japan
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Maebashi, Gunma, 371-8511, Japan
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Ōtake, Hiroshima, 739-0696, Japan
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Sapporo, Hokkaido, 060-8543, Japan
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Kobe, Hyōgo, 650-0047, Japan
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Higashiibaraki, Ibaraki, 311-3193, Japan
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Kanazawa, Ishikawa-ken, 920-8530, Japan
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Sagamihara, Kanagawa, 252-0375, Japan
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Yokohama, Kanagawa, 232-0024, Japan
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Yokosuka, Kanagawa, 238-8558, Japan
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Sendai, Miyagi, 981-8563, Japan
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Ueda, Nagano, 386-8610, Japan
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Kashihara, Nara, 634-8522, Japan
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Yufu, Oita Prefecture, 879-5593, Japan
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Sayama, Osaka, 589-8511, Japan
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Wako, Saitama, 351-0102, Japan
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Hamamatsu, Shizuoka, 431-3192, Japan
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Utsunomiya, Tochigi, 321-0974, Japan
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Bunkyo-ku, Tokyo, 113-8431, Japan
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Bunkyo-ku, Tokyo, 113-8603, Japan
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Itabashi-ku, Tokyo, 173-0015, Japan
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Minato-ku, Tokyo, 105-8471, Japan
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Mitaka, Tokyo, 181-8611, Japan
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Nakano-ku, Tokyo, 164-8541, Japan
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Shinjuku-ku, Tokyo, 160-8582, Japan
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Sumida-ku, Tokyo, 130-8587, Japan
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Ube, Yamaguchi, 755-8505, Japan
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Chiba, 260-8717, Japan
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Fukui, 910-8526, Japan
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Hiroshima, 730-8518, Japan
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Kyoto, 602-8566, Japan
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Nagasaki, 852-8501, Japan
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Nagasaki, 852-8511, Japan
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Okayama, 700-8558, Japan
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Osaka, 541-8567, Japan
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Osaka, 545-8586, Japan
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Osaka, 558-8558, Japan
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Toyama, 930-0194, Japan
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Daugavpils, LV5401, Latvia
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Jelgava, LV-3001, Latvia
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Leipaja, LV-3401, Latvia
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Riga, LV-1001, Latvia
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Riga, LV-1002, Latvia
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Riga, LV-1038, Latvia
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Kaunas, LT-45434, Lithuania
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Kaunas, LT-50009, Lithuania
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Klaipėda, LT-92288, Lithuania
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Vilnius, LT-08660, Lithuania
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Vilnius, LT-08661, Lithuania
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La Victoria, Arequipa, 4001, Peru
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Lima, 15046, Peru
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Lima, 15073, Peru
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San Isidro, 15036, Peru
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Elblag, 82-300, Poland
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Gdansk, 80-952, Poland
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Lodz, 90-302, Poland
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Lublin, 20-718, Poland
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Otwock, 05-400, Poland
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Rzeszów, 35-021, Poland
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Siedlce, 08-110, Poland
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Warsaw, 02-616, Poland
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Warsaw, 02-781, Poland
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Warsaw, 04-125, Poland
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Wroclaw, 54-144, Poland
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Guimarães, Braga District, 4835-044, Portugal
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Almada, Lisbon District, 2801-951, Portugal
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Matosinhos Municipality, Porto District, 4464-513, Portugal
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Braga, 4710-243, Portugal
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Lisbon, 1099-023, Portugal
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Lisbon, 1150-199, Portugal
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Lisbon, 1400-038, Portugal
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Lisbon, 1500-650, Portugal
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Porto, 4200-072, Portugal
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Porto, 4200-319, Portugal
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Bucharest, 22328, Romania
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Bucharest, 41345, Romania
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Bucharest, 50659, Romania
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Bucharest, 75000, Romania
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Cluj-Napoca, 400015, Romania
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Craiova, 200347, Romania
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Craiova, 200385, Romania
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Oradea, 410159, Romania
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Ploieşti, 100337, Romania
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Târgu Mureş, 540103, Romania
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Chelyabinsk, 454087, Russia
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Ivanovo, 153040, Russia
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Kazan', 420029, Russia
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Krasnoyarsk, 660133, Russia
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Moscow, 105425, Russia
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Moscow, 117997, Russia
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Moscow, 125284, Russia
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Moscow, 129301, Russia
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Nizhny Novgorod, 603006, Russia
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Novosibirsk, 630099, Russia
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Obninsk, 249036, Russia
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Omsk, 644013, Russia
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Orenburg, 460021, Russia
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Pyatigorsk, 357502, Russia
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Rostov-on-Don, 344022, Russia
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Saint Petersburg, 191014, Russia
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Saint Petersburg, 194017, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 197022, Russia
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Saratov, 410054, Russia
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Tyumen, 625041, Russia
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Ufa, 450008, Russia
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Vladimir, 600009, Russia
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Belgrade, 11000, Serbia
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Belgrade, 11080, Serbia
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Niš, 18000, Serbia
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Bratislava, 851 01, Slovakia
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Bratislava, 851 05, Slovakia
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Martin, 036 59, Slovakia
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Trenčín, 91101, Slovakia
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George, Eastern Cape, 6530, South Africa
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Port Elizabeth, Eastern Cape, 6045, South Africa
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Pretoria, Gauteng, 0002, South Africa
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Pretoria, Gauteng, 0083, South Africa
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Paarl, Western Cape, 7646, South Africa
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Rondebosch, Western Cape, 7700, South Africa
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Cape Town, 7505, South Africa
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Cape Town, 7925, South Africa
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Gwangju, Gwangju Gwang''yeogsi, 61469, South Korea
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Cheongju-si, North Chungcheong, 28644, South Korea
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Seoul, Seoul Teugbyeolsi, 03080, South Korea
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Seoul, Seoul Teugbyeolsi, 06273, South Korea
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Daegu, 41404, South Korea
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Daegu, 42601, South Korea
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Incheon, 21565, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Elche, Alicante, 03203, Spain
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Cadiz, Andalusia, 11009, Spain
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L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Sabadell, Barcelona, 08208, Spain
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Terrassa, Barcelona, 08221, Spain
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Jerez de la Frontera, Cádiz, 11407, Spain
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Manacor, Illes Baleares, 07500, Spain
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Palma de Mallorca, Illes Baleares, 07120, Spain
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Alcorcón, Madrid, 28922, Spain
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Bilbao, Vizcaya, 48013, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Córdoba, 14004, Spain
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Granada, 18012, Spain
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Lugo, 27003, Spain
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Madrid, 28007, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Málaga, 29010, Spain
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Salamanca, 37007, Spain
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Seville, 41009, Spain
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Seville, 41013, Spain
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Valencia, 46009, Spain
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Valencia, 46015, Spain
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Valencia, 46026, Spain
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Gothenburg, 413 45, Sweden
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Örebro, 701 85, Sweden
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Stockholm, 171 76, Sweden
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Uppsala, 751 85, Sweden
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Kaohsiung City, 807, Taiwan
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Kaoshiung, 81362, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 100, Taiwan
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Taoyuan District, 33305, Taiwan
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Ankara, 06500, Turkey (Türkiye)
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Istanbul, 34724, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Izmir, 35340, Turkey (Türkiye)
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Manisa, 45030, Turkey (Türkiye)
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Sivas, 58140, Turkey (Türkiye)
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Chernivtsi, 58002, Ukraine
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Dnipro, 49102, Ukraine
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Kharkiv, 61037, Ukraine
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Kryvyi Rih, 50048, Ukraine
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Kyiv, 04053, Ukraine
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Kyiv, 2660, Ukraine
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Uzhhorod, 88014, Ukraine
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Zaporizhzhya, 69600, Ukraine
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Reading, Berkshire, RG1 5AN, United Kingdom
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Llanelli, Carmarthenshire, SA14 8QF, United Kingdom
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Romford, Essex, RM7 0AG, United Kingdom
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Stevenage, Hertfordshire, SG1 4AB, United Kingdom
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Dartford, Kent, DA2 8DA, United Kingdom
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Maidstone, Kent, ME16 9QQ, United Kingdom
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Preston, Lancashire, PR2 4HT, United Kingdom
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Bebington, Merseyside, CH63 4JY, United Kingdom
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Scunthorpe, North East Lincolnshire, DN15 7BH, United Kingdom
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Bath, Somerset, BA1 3NG, United Kingdom
Unknown Facility
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
Unknown Facility
Dudley, West Midlands, DY1 2HQ, United Kingdom
Unknown Facility
Huddersfield, West Yorkshire, HD3 3EA, United Kingdom
Unknown Facility
Wakefield, West Yorkshire, WF1 4DG, United Kingdom
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Cardiff, CF14 4XN, United Kingdom
Unknown Facility
Glasgow, G12 0YN, United Kingdom
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London, SW17 0QT, United Kingdom
Related Publications (11)
Saar M, Fizazi K, Shore ND, Smith M, Damber JE, Semenov A, Ribal MJ, Birtle A, Rigaud J, Wallis CJD, Grimm MO, Halabi S, Armstrong AJ, Mohamed AF, Adorjan P, Srinivasan S, Verholen F, Morgans AK, Siemens DR. Effects of Prior Local Therapy by Radical Prostatectomy or Radiotherapy on the Efficacy and Quality of Life of Patients Treated With Darolutamide in ARAMIS. Cancer Med. 2026 Jan;15(1):e71343. doi: 10.1002/cam4.71343.
PMID: 41450200DERIVEDNi X, Sui J, Wang B, Wang H, Freedland SJ, Ye D, Zhu Y. Lower Testosterone Level and Metastases-Free Survival in Patients With Nonmetastatic Castration-Resistant Prostate Cancer Treated With Novel Antiandrogens: A Post Hoc Analysis of SPARTAN and ARAMIS. J Urol. 2025 Jul;214(1):10-17. doi: 10.1097/JU.0000000000004545. Epub 2025 Mar 25.
PMID: 40132221DERIVEDShore ND, Gratzke C, Feyerabend S, Werbrouck P, Carles J, Vjaters E, Tammela TLJ, Morris D, Aragon-Ching JB, Concepcion RS, Emmenegger U, Fleshner N, Grabbert M, Lietuvietis V, Mahammedi H, Cruz FM, Paula A, Pieczonka C, Rannikko A, Richardet M, Silveira G, Kuss I, Le Berre MA, Verholen F, Sarapohja T, Smith MR, Fizazi K. Extended Safety and Tolerability of Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer and Adverse Event Time Course in ARAMIS. Oncologist. 2024 Jul 5;29(7):581-588. doi: 10.1093/oncolo/oyae019.
PMID: 38394384DERIVEDFizazi K, Shore ND, Smith M, Ramos R, Jones R, Niegisch G, Vjaters E, Wang Y, Srinivasan S, Sarapohja T, Verholen F. Efficacy and safety outcomes of darolutamide in patients with non-metastatic castration-resistant prostate cancer with comorbidities and concomitant medications from the randomised phase 3 ARAMIS trial. Eur J Cancer. 2023 Oct;192:113258. doi: 10.1016/j.ejca.2023.113258. Epub 2023 Jul 27.
PMID: 37660438DERIVEDCarles J, Medina-Lopez RA, Puente J, Gomez-Ferrer A, Nebra JC, Saez Medina MI, Ribal MJ, Antolin AR, Alvarez-Ossorio JL, Suarez Novo JF, Agut CM, Srinivasan S, Ortiz J, Fizazi K. Darolutamide in Spanish patients with nonmetastatic castration-resistant prostate cancer: ARAMIS subgroup analysis. Future Oncol. 2023 Apr;19(12):819-828. doi: 10.2217/fon-2022-1131. Epub 2023 May 24.
PMID: 37222151DERIVEDShore ND, Stenzl A, Pieczonka C, Klaassen Z, Aronson WJ, Karsh L, Ryan CJ, Ortiz J, Srinivasan S, Mohamed AF, Verholen F. Impact of darolutamide on local symptoms: pre-planned and post hoc analyses of the ARAMIS trial. BJU Int. 2023 Apr;131(4):452-460. doi: 10.1111/bju.15887. Epub 2022 Sep 29.
PMID: 36087070DERIVEDChowdhury S, Oudard S, Uemura H, Joniau S, Dearden L, Capone C, Van Sanden S, Diels J, Hadaschik BA. Apalutamide Compared with Darolutamide for the Treatment of Non-metastatic Castration-Resistant Prostate Cancer: Efficacy and Tolerability in a Matching-Adjusted Indirect Comparison. Adv Ther. 2022 Jan;39(1):518-531. doi: 10.1007/s12325-021-01885-6. Epub 2021 Nov 19.
PMID: 34797506DERIVEDFizazi K, Blue I, Nowak JT. Darolutamide and survival in nonmetastatic, castration-resistant prostate cancer: a patient perspective of the ARAMIS trial. Future Oncol. 2021 May;17(14):1699-1707. doi: 10.2217/fon-2020-1291. Epub 2021 Feb 8.
PMID: 33554636DERIVEDFizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Le Berre MA, Petrenciuc O, Snapir A, Sarapohja T, Smith MR; ARAMIS Investigators. Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide. N Engl J Med. 2020 Sep 10;383(11):1040-1049. doi: 10.1056/NEJMoa2001342.
PMID: 32905676DERIVEDShore N, Zurth C, Fricke R, Gieschen H, Graudenz K, Koskinen M, Ploeger B, Moss J, Prien O, Borghesi G, Petrenciuc O, Tammela TL, Kuss I, Verholen F, Smith MR, Fizazi K. Evaluation of Clinically Relevant Drug-Drug Interactions and Population Pharmacokinetics of Darolutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Results of Pre-Specified and Post Hoc Analyses of the Phase III ARAMIS Trial. Target Oncol. 2019 Oct;14(5):527-539. doi: 10.1007/s11523-019-00674-0.
PMID: 31571095DERIVEDFizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Kappeler C, Snapir A, Sarapohja T, Smith MR; ARAMIS Investigators. Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2019 Mar 28;380(13):1235-1246. doi: 10.1056/NEJMoa1815671. Epub 2019 Feb 14.
PMID: 30763142DERIVED
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2014
First Posted
July 25, 2014
Study Start
September 12, 2014
Primary Completion
September 3, 2018
Study Completion
June 14, 2021
Last Updated
June 28, 2022
Results First Posted
October 29, 2019
Record last verified: 2022-06