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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer Non-Metastatic; Castration-Resistant
• Intervention / Treatment: Drug: Darolutamide (Nubeqa, BAY1841788); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1509
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, X5016KEH
  • Córdoba, Argentina, X5000HXL
  • Córdoba, Argentina, X5004FHP
  • La Rioja, Argentina, F5300COE
  • Ciudad Auton. De Buenos Aires
    • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1120AAT
  • Santa Fe
    • Santa Fé, Santa Fe, Argentina, S3000FFV
  • Tucuman
    • San Miguel de Tucumán, Tucuman, Argentina, T4000HXU
• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
    • St Leonards, New South Wales, Australia, 2065
  • Queensland
    • Douglas, Queensland, Australia, 4814
    • South Brisbane, Queensland, Australia, 4101
  • South Australia
    • Kurralta Park, South Australia, Australia, 5037
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
• Austria
  • Wien, Austria, 1090
  • Wien, Austria, 1020
• Belarus
  • Lesnoy, Belarus, 223040
  • Minsk, Belarus, 220013
• Belgium
  • Bonheiden, Belgium, 2820
  • Kortrijk, Belgium, 8500
  • Libramont, Belgium, 6800
  • Liege, Belgium, 4000
  • Sint-truiden, Belgium, 3800
• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 40050-001
  • Ceará
    • Fortaleza, Ceará, Brazil, 60430-230
  • Goiás
    • Goiânia, Goiás, Brazil, 74605-070
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-320
    • Juiz de Fora, Minas Gerais, Brazil, 36010-510
    • Uberlandia, Minas Gerais, Brazil, 38408-150
  • Parana
    • Curitiba, Parana, Brazil, 81520-060
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50070-550
  • Rio Grande Do Sul
    • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90050 170
  • Santa Catarina
    • Itajaí, Santa Catarina, Brazil, 88301-220
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784-400
    • Jau, Sao Paulo, Brazil, 17210-080
    • Ribeirao Preto - SP, Sao Paulo, Brazil, 14048-900
    • Sorocaba, Sao Paulo, Brazil, 18035-300
    • São Paulo, Sao Paulo, Brazil, 04039-004
    • São Paulo, Sao Paulo, Brazil, 04014-002
    • São Paulo, Sao Paulo, Brazil, 01246-000
    • São Paulo, Sao Paulo, Brazil, 01209-000
    • São Paulo, Sao Paulo, Brazil, 01236-030
• Bulgaria
  • Sofia, Bulgaria, 1680
  • Varna, Bulgaria, 9000
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2V 1P9
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
  • Ontario
    • Burlington, Ontario, Canada, L7N 3V2
    • Hamilton, Ontario, Canada, L8N 4A6
    • Kingston, Ontario, Canada, K7L 3J7
    • London, Ontario, Canada, N6A 5W9
    • Toronto, Ontario, Canada, M5G 2M9
    • Toronto, Ontario, Canada, M4N 3M5
  • Quebec
    • Granby, Quebec, Canada, J2G 8Z9
    • Pointe-Claire, Quebec, Canada, H9R 4S3
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050034
  • Córdoba
    • Montería, Córdoba, Colombia, 230002
  • Santander
    • Floridablanca, Santander, Colombia, 681004
• Czechia
  • Jablonec nad Nisou, Czechia, 466 60
  • Kolin, Czechia, 280 00
  • Olomouc, Czechia, 775 20
  • Opava, Czechia, 746 01
  • Praha 2, Czechia, 128 08
  • Praha 2, Czechia, 120 00
  • Praha 6, Czechia, 160 00
  • Praha 8, Czechia, 180 81
• Estonia
  • Tallinn, Estonia, 13419
• Finland
  • Helsinki, Finland, 00290
  • Kuopio, Finland, 70210
  • Seinäjoki, Finland, 60220
  • Tampere, Finland, 33521
  • Turku, Finland, FIN-20521
• France
  • Angers, France, 49100
  • Bayonne, France, 64100
  • Besancon, France, 25030
  • Bordeaux Cedex, France, 33076
  • CAEN cedex 05, France, 14076
  • Cergy Pontoise, France, 95303
  • Clermont Ferrand Cedex 1, France, 63011
  • Creteil, France, 94010
  • Dijon, France, 21000
  • LA ROCHE SUR YON cedex, France, 85925
  • Limoges Cedex, France, 87042
  • Montpellier Cedex, France, 34295
  • Montpellier Cedex, France, 34298
  • Nancy, France, 54100
  • Nantes Cedex, France, 44093
  • POITIERS cedex, France, 86021
  • Paris, France, 75014
  • Paris, France, 75010
  • Pierre Benite, France, 69495
  • REIMS cedex, France, 51726
  • Rennes Cedex, France, 35033
  • Rouen Cedex, France, 76031
  • Saint Mande, France, 94160
  • Strasbourg, France, 67000
  • Suresnes, France, 92151
  • Tours, France, 37044
  • Villejuif Cedex, France, 94805
• Germany
  • Berlin, Germany, 12203
  • Hamburg, Germany, 22081
  • Hamburg, Germany, 20246
  • Baden-Württemberg
    • Emmendingen, Baden-Württemberg, Germany, 79312
    • Kirchheim unter Teck, Baden-Württemberg, Germany, 73230
    • Muehlacker, Baden-Württemberg, Germany, 75417
    • Nürtingen, Baden-Württemberg, Germany, 72622
    • Reutlingen, Baden-Württemberg, Germany, 72764
    • Tübingen, Baden-Württemberg, Germany, 72076
  • Bayern
    • Zirndorf, Bayern, Germany, 90513
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
    • Marburg, Hessen, Germany, 35039
  • Mecklenburg-Vorpommern
    • Hagenow, Mecklenburg-Vorpommern, Germany, 19230
  • Niedersachsen
    • Herzberg Am Harz, Niedersachsen, Germany, 37412
    • Holzminden, Niedersachsen, Germany, 37603
  • Nordrhein-Westfalen
    • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
    • Köln, Nordrhein-Westfalen, Germany, 50937
    • Mühlheim, Nordrhein-Westfalen, Germany, 45468
    • Münster, Nordrhein-Westfalen, Germany, 48149
    • Wuppertal, Nordrhein-Westfalen, Germany, 42103
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
• Hungary
  • Budapest, Hungary, 1145
  • Budapest, Hungary, 1204
  • Budapest, Hungary, 1086
  • Debrecen, Hungary, 4032
  • Gyor, Hungary, 9023
  • Nyiregyhaza, Hungary, 4400
  • Szeged, Hungary, 6725
  • Szekszard, Hungary, 7100
  • Szolnok, Hungary, 5000
  • Zalaegerszeg, Hungary, 8900
• Israel
  • Haifa, Israel, 35152
• Italy
  • Abruzzo
    • Chieti, Abruzzo, Italy, 66100
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
  • Campania
    • Napoli, Campania, Italy, 80131
  • Emilia-Romagna
    • Forlì Cesena, Emilia-Romagna, Italy, 47014
    • Modena, Emilia-Romagna, Italy, 41124
    • Parma, Emilia-Romagna, Italy, 43126
  • Lazio
    • Roma, Lazio, Italy, 00144
    • Roma, Lazio, Italy, 00189
  • Piemonte
    • Torino, Piemonte, Italy, 10043
    • Torino, Piemonte, Italy, 10060
  • Puglia
    • Lecce, Puglia, Italy, 73100
  • Sicilia
    • Messina, Sicilia, Italy, 98125
    • Palermo, Sicilia, Italy, 90127
  • Toscana
    • Arezzo, Toscana, Italy, 52100
• Japan
  • Chiba, Japan, 260-8717
  • Fukui, Japan, 910-8526
  • Hiroshima, Japan, 730-8518
  • Kyoto, Japan, 602-8566
  • Nagasaki, Japan, 852-8501
  • Nagasaki, Japan, 852-8511
  • Okayama, Japan, 700-8558
  • Osaka, Japan, 558-8558
  • Osaka, Japan, 545-8586
  • Osaka, Japan, 541-8567
  • Toyama, Japan, 930-0194
  • Aichi
    • Nagoya, Aichi, Japan, 466-8560
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
  • Fukuoka
    • Kurume, Fukuoka, Japan, 839-0863
  • Fukushima
    • Koriyama, Fukushima, Japan, 963-8052
  • Gunma
    • Maebashi, Gunma, Japan, 371-8511
  • Hiroshima
    • Otake, Hiroshima, Japan, 739-0696
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8543
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0047
  • Ibaraki
    • Higashiibaraki, Ibaraki, Japan, 311-3193
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-8530
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0375
    • Yokohama, Kanagawa, Japan, 232-0024
    • Yokosuka, Kanagawa, Japan, 238-8558
  • Miyagi
    • Sendai, Miyagi, Japan, 981-8563
  • Nagano
    • Ueda, Nagano, Japan, 386-8610
  • Nara
    • Kashihara, Nara, Japan, 634-8522
  • Oita
    • Yufu, Oita, Japan, 879-5593
  • Osaka
    • Osakasayama, Osaka, Japan, 589-8511
  • Saitama
    • Wako, Saitama, Japan, 351-0102
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
  • Tochigi
    • Utsunomiya, Tochigi, Japan, 321-0974
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8603
    • Bunkyo-ku, Tokyo, Japan, 113-8431
    • Itabashi-ku, Tokyo, Japan, 173-0015
    • Minato-ku, Tokyo, Japan, 105-8471
    • Mitaka, Tokyo, Japan, 181-8611
    • Nakano-ku, Tokyo, Japan, 164-8541
    • Shinjuku-ku, Tokyo, Japan, 160-8582
    • Sumida-ku, Tokyo, Japan, 130-8587
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-8505
• Korea, Republic of
  • Daegu, Korea, Republic of, 42601
  • Daegu, Korea, Republic of, 41404
  • Incheon, Korea, Republic of, 21565
  • Seoul, Korea, Republic of, 05505
  • Seoul, Korea, Republic of, 06351
  • Seoul, Korea, Republic of, 03722
  • Seoul, Korea, Republic of, 06591
  • Chungcheongbugdo
    • Cheongju, Chungcheongbugdo, Korea, Republic of, 28644
  • Gwangju Gwang''yeogsi
    • Gwangju, Gwangju Gwang''yeogsi, Korea, Republic of, 61469
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06273
• Latvia
  • Daugavpils, Latvia, LV5401
  • Jelgava, Latvia, LV-3001
  • Leipaja, Latvia, LV-3401
  • Riga, Latvia, LV-1002
  • Riga, Latvia, LV-1038
  • Riga, Latvia, LV-1001
• Lithuania
  • Kaunas, Lithuania, LT-50009
  • Kaunas, Lithuania, LT-45434
  • Klaipeda, Lithuania, LT-92288
  • Vilnius, Lithuania, LT-08661
  • Vilnius, Lithuania, LT-08660
• Peru
  • Lima, Peru, 15046
  • Lima, Peru, 15073
  • San Isidro, Peru, 15036
  • Arequipa
    • La Victoria, Arequipa, Peru, 4001
• Poland
  • Elblag, Poland, 82-300
  • Gdansk, Poland, 80-952
  • Lodz, Poland, 90-302
  • Lublin, Poland, 20-718
  • Otwock, Poland, 05-400
  • Rzeszow, Poland, 35-021
  • Siedlce, Poland, 08-110
  • Warszawa, Poland, 02-781
  • Warszawa, Poland, 02-616
  • Warszawa, Poland, 04-125
  • Wroclaw, Poland, 54-144
• Portugal
  • Braga, Portugal, 4710-243
  • Lisboa, Portugal, 1150-199
  • Lisboa, Portugal, 1099-023
  • Lisboa, Portugal, 1500-650
  • Lisboa, Portugal, 1400-038
  • Porto, Portugal, 4200-319
  • Porto, Portugal, 4200-072
  • Braga
    • Guimaraes, Braga, Portugal, 4835-044
  • Lisboa
    • Almada, Lisboa, Portugal, 2801-951
  • Porto
    • Matosinhos, Porto, Portugal, 4464-513
• Romania
  • Bucuresti, Romania, 50659
  • Bucuresti, Romania, 22328
  • Bucuresti, Romania, 41345
  • Bucuresti, Romania, 75000
  • Cluj-Napoca, Romania, 400015
  • Craiova, Romania, 200385
  • Craiova, Romania, 200347
  • Oradea, Romania, 410159
  • Ploiesti, Romania, 100337
  • Targu-Mures, Romania, 540103
• Russian Federation
  • Chelyabinsk, Russian Federation, 454087
  • Ivanovo, Russian Federation, 153040
  • Kazan, Russian Federation, 420029
  • Krasnoyarsk, Russian Federation, 660133
  • Moscow, Russian Federation, 125284
  • Moscow, Russian Federation, 129301
  • Moscow, Russian Federation, 117997
  • Moscow, Russian Federation, 105425
  • Nizhny Novgorod, Russian Federation, 603006
  • Novosibirsk, Russian Federation, 630099
  • Obninsk, Russian Federation, 249036
  • Omsk, Russian Federation, 644013
  • Orenburg, Russian Federation, 460021
  • Pyatigorsk, Russian Federation, 357502
  • Rostov-on-Don, Russian Federation, 344022
  • Saratov, Russian Federation, 410054
  • St. Petersburg, Russian Federation, 197022
  • St. Petersburg, Russian Federation, 194354
  • St. Petersburg, Russian Federation, 194017
  • St. Petersburg, Russian Federation, 191014
  • Tyumen, Russian Federation, 625041
  • Ufa, Russian Federation, 450008
  • Vladimir, Russian Federation, 600009
• Serbia
  • Belgrade, Serbia, 11000
  • Belgrade, Serbia, 11080
  • Nis, Serbia, 18000
• Slovakia
  • Bratislava, Slovakia, 851 01
  • Bratislava, Slovakia, 851 05
  • Martin, Slovakia, 036 59
  • Trencin, Slovakia, 91101
• South Africa
  • Cape Town, South Africa, 7925
  • Cape Town, South Africa, 7505
  • Eastern Cape
    • George, Eastern Cape, South Africa, 6530
    • Port Elizabeth, Eastern Cape, South Africa, 6045
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0083
    • Pretoria, Gauteng, South Africa, 0002
  • Western Cape
    • Paarl, Western Cape, South Africa, 7646
    • Rondebosch, Western Cape, South Africa, 7700
• Spain
  • Barcelona, Spain, 08036
  • Barcelona, Spain, 08035
  • Córdoba, Spain, 14004
  • Granada, Spain, 18012
  • Lugo, Spain, 27003
  • Madrid, Spain, 28040
  • Madrid, Spain, 28046
  • Madrid, Spain, 28041
  • Madrid, Spain, 28007
  • Málaga, Spain, 29010
  • Salamanca, Spain, 37007
  • Sevilla, Spain, 41013
  • Sevilla, Spain, 41009
  • Valencia, Spain, 46026
  • Valencia, Spain, 46009
  • Valencia, Spain, 46015
  • Alicante
    • Elche, Alicante, Spain, 03203
  • Andalucía
    • Cádiz, Andalucía, Spain, 11009
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    • Sabadell, Barcelona, Spain, 08208
    • Terrassa, Barcelona, Spain, 08221
  • Cádiz
    • Jerez de la Frontera, Cádiz, Spain, 11407
  • Illes Baleares
    • Manacor, Illes Baleares, Spain, 07500
    • Palma de Mallorca, Illes Baleares, Spain, 07120
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
• Sweden
  • Göteborg, Sweden, 413 45
  • Stockholm, Sweden, 171 76
  • Uppsala, Sweden, 751 85
  • Örebro, Sweden, 701 85
• Taiwan
  • Kaohsiung City ,, Taiwan, 807
  • Kaoshiung, Taiwan, 81362
  • Taichung, Taiwan, 40705
  • Taipei, Taiwan, 100
  • Taoyuan, Taiwan, 33305
• Turkey
  • Ankara, Turkey, 06500
  • Istanbul, Turkey, 34724
  • Izmir, Turkey, 35100
  • Izmir, Turkey, 35340
  • Manisa, Turkey, 45030
  • Sivas, Turkey, 58140
• Ukraine
  • Chernivtsi, Ukraine, 58002
  • Dnipro, Ukraine, 49102
  • Kharkiv, Ukraine, 61037
  • Kryvyi Rih, Ukraine, 50048
  • Kyiv, Ukraine, 04053
  • Kyiv, Ukraine, 2660
  • Uzhgorod, Ukraine, 88014
  • Zaporozhye, Ukraine, 69600
• United Kingdom
  • Cardiff, United Kingdom, CF14 4XN
  • Glasgow, United Kingdom, G12 0YN
  • London, United Kingdom, SW17 0QT
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG1 5AN
  • Carmarthenshire
    • Llanelli, Carmarthenshire, United Kingdom, SA14 8QF
  • Essex
    • Romford, Essex, United Kingdom, RM7 0AG
  • Hertfordshire
    • Stevenage, Hertfordshire, United Kingdom, SG1 4AB
  • Kent
    • Dartford, Kent, United Kingdom, DA2 8DA
    • Maidstone, Kent, United Kingdom, ME16 9QQ
  • Lancashire
    • Preston, Lancashire, United Kingdom, PR2 4HT
  • Merseyside
    • Bebington, Merseyside, United Kingdom, CH63 4JY
  • North East Lincolnshire
    • Scunthorpe, North East Lincolnshire, United Kingdom, DN15 7BH
  • Somerset
    • Bath, Somerset, United Kingdom, BA1 3NG
  • Staffordshire
    • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
  • West Midlands
    • Dudley, West Midlands, United Kingdom, DY1 2HQ
  • West Yorkshire
    • Huddersfield, West Yorkshire, United Kingdom, HD3 3EA
    • Wakefield, West Yorkshire, United Kingdom, WF1 4DG
• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
  • Alaska
    • Anchorage, Alaska, United States, 99503
  • Arizona
    • Tucson, Arizona, United States, 85704
  • California
    • Fountain Valley, California, United States, 92708
    • La Jolla, California, United States, 92093
    • Laguna Hills, California, United States, 92653
    • Los Angeles, California, United States, 90048
    • Los Angeles, California, United States, 90073-1003
    • San Diego, California, United States, 92120
    • Whittier, California, United States, 90603
  • Colorado
    • Denver, Colorado, United States, 80220
    • Denver, Colorado, United States, 80211
    • Parker, Colorado, United States, 80134
  • Florida
    • Boca Raton, Florida, United States, 33486
    • Orlando, Florida, United States, 32803
    • Port Saint Lucie, Florida, United States, 34952
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
  • Illinois
    • Chicago, Illinois, United States, 60612
    • Evanston, Illinois, United States, 60201-1613
    • Springfield, Illinois, United States, 62702
  • Indiana
    • Greenwood, Indiana, United States, 46143
    • Indianapolis, Indiana, United States, 46202
    • Jeffersonville, Indiana, United States, 47130
  • Iowa
    • West Des Moines, Iowa, United States, 50266
  • Kansas
    • Wichita, Kansas, United States, 67226
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
  • Maryland
    • Annapolis, Maryland, United States, 21401
    • Baltimore, Maryland, United States, 21204
    • Salisbury, Maryland, United States, 21801
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
    • Royal Oak, Michigan, United States, 48073
  • Nebraska
    • Omaha, Nebraska, United States, 68114
    • Omaha, Nebraska, United States, 68130
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756-1000
  • New Jersey
    • Voorhees, New Jersey, United States, 08043
  • New York
    • Bronx, New York, United States, 10461
    • Bronx, New York, United States, 10469
    • Syracuse, New York, United States, 13210
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
    • Charlotte, North Carolina, United States, 28277
  • Ohio
    • Canton, Ohio, United States, 44718
    • Cincinnati, Ohio, United States, 45212
    • Cleveland, Ohio, United States, 44195
    • Gahanna, Ohio, United States, 43230
    • Middleburg Heights, Ohio, United States, 44130
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
  • Tennessee
    • Nashville, Tennessee, United States, 37209
  • Texas
    • Dallas, Texas, United States, 75231
  • Virginia
    • Fairfax, Virginia, United States, 22031
    • Richmond, Virginia, United States, 23235
    • Virginia Beach, Virginia, United States, 23462
  • West Virginia
    • Wheeling, West Virginia, United States, 26003

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease.
• Treatment with any investigational drug within 28 days before randomisation.
• Any condition that in the opinion of the investigator would impair the patients' ability to comply with the study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Darolutamide (BAY1841788); Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg.	Drug: Darolutamide (Nubeqa, BAY1841788); Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.; Other Names: ODM-201
Placebo Comparator: Placebo; Participants received matching placebo 2 tablets twice daily with food.	Drug: Placebo; Matching placebo 2 tablets twice daily with food.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival - Primary Analysis	Overall Survival (OS) was defined as the time from randomization to death due to any cause.	From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 months)
Time to Pain Progression - Primary Analysis	Time to pain progression (PP) is defined as time from randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline in question 3 of the Brief Pain Inventory-Short Form questionnaire (BPI-SF) related to the worst pain in the last 24 hours taken as a 7-day average for post-baseline scores, or initiation of short or long-acting opioids for pain, whichever comes first. Initiation or change in the use of other non-opioid analgesics is not used in the analysis of pain progression.	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	The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle.	From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
Time to First Symptomatic Skeletal Event (SSE) - Primary Analysis	The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE.	From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
Overall Survival - Final Analysis	Overall Survival (OS) was defined as the time from randomization to death due to any cause. The final analysis was done at the time of the data cut-off (15 NOV 2019).	From randomization of the first subject to the time approximatively 254 death events were observed (approximately 56 months)
Time to Pain Progression - Final Analysis	For time to pain progression, the analysis performed using the primary completion cut-off data (03 SEP 2018) was considered final and no new analysis was performed for time to pain progression.	From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Final Analysis	The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle. The final analysis was done at the time of the data cut-off (15 NOV 2019).	From randomization until initiation of first cytotoxic chemotherapy treatment (approximately 59 months)
Time to First Symptomatic Skeletal Event (SSE) - Final Analysis	The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE. The final analysis was done at the time of the data cut-off (15 NOV 2019).	From randomization until occurrence of first SSE event (approximately 59 months)

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Orion Corporation, Orion Pharma

Publications and helpful links

General Publications

• Chowdhury 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.
• Fizazi 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. Erratum in: Future Oncol. 2022 Jan;18(2):275.
• Fizazi 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.
• Shore 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.
• Fizazi 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. Erratum In: N Engl J Med. 2022 Sep 1;387(9):860.

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
• Click here to find results for studies related to Bayer products.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2014
• Primary Completion (Actual): September 3, 2018
• Study Completion (Actual): June 14, 2021

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: July 23, 2014
• First Posted (Estimate): July 25, 2014

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 17712; 2013-003820-36 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No