AzTrials
AzTrials

Prostate Cancer Non-MetastaticPhase 3ARAMISNCT02200614

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

A Phase 3 study testing Darolutamide (Nubeqa, BAY1841788) in people with Prostate Cancer Non-Metastatic and Castration-Resistant, run by Bayer at 404 sites in 36 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Darolutamide (Nubeqa, BAY1841788)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,509 participants
Where
404 sitesin 36 countries
Study dates
12 Sep 2014to 14 Jun 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

404 sites in 36 countries.

404 sites in 36 countries

United States55 sites

  • Study site

    Anchorage, Alaska, 99503

  • Study site

    Annapolis, Maryland, 21401

  • Study site

    Asheboro, North Carolina, 27203

  • Study site

    Bala-Cynwyd, Pennsylvania, 19004

  • Study site

    Baltimore, Maryland, 21204

  • Study site

    Boca Raton, Florida, 33486

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Canton, Ohio, 44718

  • Study site

    Charlotte, North Carolina, 28277

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Cincinnati, Ohio, 45212

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Coeur d'Alene, Idaho, 83814

  • Study site

    Dallas, Texas, 75231

  • Study site

    Denver, Colorado, 80211

  • Study site

    Denver, Colorado, 80220

  • Study site

    Evanston, Illinois, 60201-1613

  • Study site

    Fairfax, Virginia, 22031

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Gahanna, Ohio, 43230

  • Study site

    Grand Rapids, Michigan, 49546

  • Study site

    Greenwood, Indiana, 46143

  • Study site

    Homewood, Alabama, 35209

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Jeffersonville, Indiana, 47130

  • Study site

    La Jolla, California, 92093

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Lebanon, New Hampshire, 03756-1000

  • Study site

    Los Angeles, California, 90048

  • Study site

    Los Angeles, California, 90073-1003

  • Study site

    Middleburg Heights, Ohio, 44130

  • Study site

    Myrtle Beach, South Carolina, 29572

  • Study site

    Nashville, Tennessee, 37209

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Omaha, Nebraska, 68130

  • Study site

    Orlando, Florida, 32803

  • Study site

    Parker, Colorado, 80134

  • Study site

    Port Saint Lucie, Florida, 34952

  • Study site

    Richmond, Virginia, 23235

  • Study site

    Royal Oak, Michigan, 48073

  • Study site

    Salisbury, Maryland, 21801

  • Study site

    San Diego, California, 92120

  • Study site

    Springfield, Illinois, 62702

  • Study site

    Syracuse, New York, 13210

  • Study site

    The Bronx, New York, 10461

  • Study site

    The Bronx, New York, 10469

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Virginia Beach, Virginia, 23462

  • Study site

    Voorhees Township, New Jersey, 08043

  • Study site

    West Des Moines, Iowa, 50266

  • Study site

    Wheeling, West Virginia, 26003

  • Study site

    Whittier, California, 90603

  • Study site

    Wichita, Kansas, 67226

Other trials in United States

Japan41 sites

  • Study site

    Bunkyo-ku, Tokyo, 113-8431

  • Study site

    Bunkyo-ku, Tokyo, 113-8603

  • Study site

    Chiba, 260-8717

  • Study site

    Fukui, 910-8526

  • Study site

    Hamamatsu, Shizuoka, 431-3192

  • Study site

    Higashiibaraki, Ibaraki, 311-3193

  • Study site

    Hiroshima, 730-8518

  • Study site

    Kanazawa, Ishikawa-ken, 920-8530

  • Study site

    Kashihara, Nara, 634-8522

  • Study site

    Kashiwa, Chiba, 277-8577

  • Study site

    Kobe, Hyōgo, 650-0047

  • Study site

    Kōriyama, Fukushima, 963-8052

  • Study site

    Kurume, Fukuoka, 839-0863

  • Study site

    Kyoto, 602-8566

  • Study site

    Maebashi, Gunma, 371-8511

  • Study site

    Minato-ku, Tokyo, 105-8471

  • Study site

    Mitaka, Tokyo, 181-8611

  • Study site

    Nagasaki, 852-8501

  • Study site

    Nagasaki, 852-8511

  • Study site

    Nagoya, Aichi-ken, 466-8560

  • Study site

    Nakano-ku, Tokyo, 164-8541

  • Study site

    Okayama, 700-8558

  • Study site

    Osaka, 541-8567

  • Study site

    Osaka, 545-8586

  • Study site

    Osaka, 558-8558

  • Study site

    Ōtake, Hiroshima, 739-0696

  • Study site

    Sagamihara, Kanagawa, 252-0375

  • Study site

    Sapporo, Hokkaido, 060-8543

  • Study site

    Sayama, Osaka, 589-8511

  • Study site

    Sendai, Miyagi, 981-8563

  • Study site

    Shinjuku-ku, Tokyo, 160-8582

  • Study site

    Sumida-ku, Tokyo, 130-8587

  • Study site

    tabashi City, Tokyo, 173-0015

  • Study site

    Toyama, 930-0194

  • Study site

    Ube, Yamaguchi, 755-8505

  • Study site

    Ueda, Nagano, 386-8610

  • Study site

    Utsunomiya, Tochigi, 321-0974

  • Study site

    Wako, Saitama, 351-0102

  • Study site

    Yokohama, Kanagawa, 232-0024

  • Study site

    Yokosuka, Kanagawa, 238-8558

  • Study site

    Yufu, Oita Prefecture, 879-5593

Other trials in Japan

France27 sites

  • Study site

    Angers, 49100

  • Study site

    Bayonne, 64100

  • Study site

    Besançon, 25030

  • Study site

    Bordeaux, 33076

  • Study site

    Caen, 14076

  • Study site

    Cergy-Pontoise, 95303

  • Study site

    Clermont-Ferrand, 63011

  • Study site

    Créteil, 94010

  • Study site

    Dijon, 21000

  • Study site

    La Roche-sur-Yon, 85925

  • Study site

    Limoges, 87042

  • Study site

    Montpellier, 34295

  • Study site

    Montpellier, 34298

  • Study site

    Nancy, 54100

  • Study site

    Nantes, 44093

  • Study site

    Paris, 75010

  • Study site

    Paris, 75014

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Poitiers, 86021

  • Study site

    Reims, 51726

  • Study site

    Rennes, 35033

  • Study site

    Rouen, 76031

  • Study site

    Saint-Mandé, 94160

  • Study site

    Strasbourg, 67000

  • Study site

    Suresnes, 92151

  • Study site

    Tours, 37044

  • Study site

    Villejuif, 94805

Other trials in France

Spain26 sites

  • Study site

    Alcorcón, Madrid, 28922

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona, 08036

  • Study site

    Bilbao, Vizcaya, 48013

  • Study site

    Cadiz, Andalusia, 11009

  • Study site

    Córdoba, 14004

  • Study site

    Elche, Alicante, 03203

  • Study site

    Granada, 18012

  • Study site

    Jerez de la Frontera, Cádiz, 11407

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Lugo, 27003

  • Study site

    Madrid, 28007

  • Study site

    Madrid, 28040

  • Study site

    Madrid, 28041

  • Study site

    Madrid, 28046

  • Study site

    Málaga, 29010

  • Study site

    Manacor, Illes Baleares, 07500

  • Study site

    Palma de Mallorca, Illes Baleares, 07120

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    Salamanca, 37007

  • Study site

    Seville, 41009

  • Study site

    Seville, 41013

  • Study site

    Terrassa, Barcelona, 08221

  • Study site

    Valencia, 46009

  • Study site

    Valencia, 46015

  • Study site

    Valencia, 46026

Other trials in Spain

Germany23 sites

  • Study site

    Berlin, 12203

  • Study site

    Cologne, North Rhine-Westphalia, 50937

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Study site

    Emmendingen, Baden-Wurttemberg, 79312

  • Study site

    Frankfurt am Main, Hesse, 60590

  • Study site

    Hagenow, Mecklenburg-Vorpommern, 19230

  • Study site

    Hamburg, 20246

  • Study site

    Hamburg, 22081

  • Study site

    Herzberg am Harz, Lower Saxony, 37412

  • Study site

    Holzminden, Lower Saxony, 37603

  • Study site

    Kirchheim unter Teck, Baden-Wurttemberg, 73230

  • Study site

    Magdeburg, Saxony-Anhalt, 39120

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    Marburg, Hesse, 35039

  • Study site

    Mühlacker, Baden-Wurttemberg, 75417

  • Study site

    Mülheim, North Rhine-Westphalia, 45468

  • Study site

    Münster, North Rhine-Westphalia, 48149

  • Study site

    Nürtingen, Baden-Wurttemberg, 72622

  • Study site

    Reutlingen, Baden-Wurttemberg, 72764

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

  • Study site

    Wuppertal, North Rhine-Westphalia, 42103

  • Study site

    Zirndorf, Bavaria, 90513

Other trials in Germany

Russia23 sites

  • Study site

    Chelyabinsk, 454087

  • Study site

    Ivanovo, 153040

  • Study site

    Kazan', 420029

  • Study site

    Krasnoyarsk, 660133

  • Study site

    Moscow, 105425

  • Study site

    Moscow, 117997

  • Study site

    Moscow, 125284

  • Study site

    Moscow, 129301

  • Study site

    Nizhny Novgorod, 603006

  • Study site

    Novosibirsk, 630099

  • Study site

    Obninsk, 249036

  • Study site

    Omsk, 644013

  • Study site

    Orenburg, 460021

  • Study site

    Pyatigorsk, 357502

  • Study site

    Rostov-on-Don, 344022

  • Study site

    Saint Petersburg, 191014

  • Study site

    Saint Petersburg, 194017

  • Study site

    Saint Petersburg, 194354

  • Study site

    Saint Petersburg, 197022

  • Study site

    Saratov, 410054

  • Study site

    Tyumen, 625041

  • Study site

    Ufa, 450008

  • Study site

    Vladimir, 600009

Other trials in Russia

Brazil21 sites

  • Study site

    Barretos, São Paulo, 14784-400

  • Study site

    Belo Horizonte, Minas Gerais, 30150-320

  • Study site

    Curitiba, Paraná, 81520-060

  • Study site

    Fortaleza, Ceará, 60430-230

  • Study site

    Goiânia, Goiás, 74605-070

  • Study site

    Itajaí, Santa Catarina, 88301-220

  • Study site

    Jaú, São Paulo, 17210-080

  • Study site

    Juiz de Fora, Minas Gerais, 36010-510

  • Study site

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Study site

    Porto Alegre, Rio Grande do Sul, 90050 170

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    Recife, Pernambuco, 50070-550

  • Study site

    Ribeirao Preto - SP, São Paulo, 14048-900

  • Study site

    Salvador, Estado de Bahia, 40050-001

  • Study site

    São Paulo, São Paulo, 01209-000

  • Study site

    São Paulo, São Paulo, 01236-030

  • Study site

    São Paulo, São Paulo, 01246-000

  • Study site

    São Paulo, São Paulo, 04014-002

  • Study site

    São Paulo, São Paulo, 04039-004

  • Study site

    Sorocaba, São Paulo, 18035-300

  • Study site

    Uberlândia, Minas Gerais, 38408-150

Other trials in Brazil

United Kingdom17 sites

  • Study site

    Bath, Somerset, BA1 3NG

  • Study site

    Bebington, Merseyside, CH63 4JY

  • Study site

    Cardiff, CF14 4XN

  • Study site

    Dartford, Kent, DA2 8DA

  • Study site

    Dudley, West Midlands, DY1 2HQ

  • Study site

    Glasgow, G12 0YN

  • Study site

    Huddersfield, West Yorkshire, HD3 3EA

  • Study site

    Llanelli, Carmarthenshire, SA14 8QF

  • Study site

    London, SW17 0QT

  • Study site

    Maidstone, Kent, ME16 9QQ

  • Study site

    Preston, Lancashire, PR2 4HT

  • Study site

    Reading, Berkshire, RG1 5AN

  • Study site

    Romford, Essex, RM7 0AG

  • Study site

    Scunthorpe, North East Lincolnshire, DN15 7BH

  • Study site

    Stevenage, Hertfordshire, SG1 4AB

  • Study site

    Stoke-on-Trent, Staffordshire, ST4 6QG

  • Study site

    Wakefield, West Yorkshire, WF1 4DG

Other trials in United Kingdom

Italy14 sites

  • Study site

    Arezzo, Tuscany, 52100

  • Study site

    Catanzaro, Calabria, 88100

  • Study site

    Chieti, Abruzzo, 66100

  • Study site

    Forlì Cesena, Emilia-Romagna, 47014

  • Study site

    Lecce, Apulia, 73100

  • Study site

    Messina, Sicily, 98125

  • Study site

    Modena, Emilia-Romagna, 41124

  • Study site

    Naples, Campania, 80131

  • Study site

    Palermo, Sicily, 90127

  • Study site

    Parma, Emilia-Romagna, 43126

  • Study site

    Rome, Lazio, 00144

  • Study site

    Rome, Lazio, 00189

  • Study site

    Turin, Piedmont, 10043

  • Study site

    Turin, Piedmont, 10060

Other trials in Italy

Poland11 sites

  • Study site

    Elblag, 82-300

  • Study site

    Gdansk, 80-952

  • Study site

    Lodz, 90-302

  • Study site

    Lublin, 20-718

  • Study site

    Otwock, 05-400

  • Study site

    Rzeszów, 35-021

  • Study site

    Siedlce, 08-110

  • Study site

    Warsaw, 02-616

  • Study site

    Warsaw, 02-781

  • Study site

    Warsaw, 04-125

  • Study site

    Wroclaw, 54-144

Other trials in Poland

South Korea11 sites

  • Study site

    Cheongju-si, North Chungcheong, 28644

  • Study site

    Daegu, 41404

  • Study site

    Daegu, 42601

  • Study site

    Gwangju, Gwangju Gwang''yeogsi, 61469

  • Study site

    Incheon, 21565

  • Study site

    Seoul, Seoul Teugbyeolsi, 03080

  • Study site

    Seoul, Seoul Teugbyeolsi, 06273

  • Study site

    Seoul, 03722

  • Study site

    Seoul, 05505

  • Study site

    Seoul, 06351

  • Study site

    Seoul, 06591

Other trials in South Korea

Canada10 sites

  • Study site

    Burlington, Ontario, L7N 3V2

  • Study site

    Calgary, Alberta, T2V 1P9

  • Study site

    Granby, Quebec, J2G 8Z9

  • Study site

    Halifax, Nova Scotia, B3H 2Y9

  • Study site

    Hamilton, Ontario, L8N 4A6

  • Study site

    Kingston, Ontario, K7L 3J7

  • Study site

    London, Ontario, N6A 5W9

  • Study site

    Pointe-Claire, Quebec, H9R 4S3

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Hungary10 sites

  • Study site

    Budapest, 1086

  • Study site

    Budapest, 1145

  • Study site

    Budapest, 1204

  • Study site

    Debrecen, 4032

  • Study site

    Győr, 9023

  • Study site

    Nyíregyháza, 4400

  • Study site

    Szeged, 6725

  • Study site

    Szekszárd, 7100

  • Study site

    Szolnok, 5000

  • Study site

    Zalaegerszeg, 8900

Other trials in Hungary

Portugal10 sites

  • Study site

    Almada, Lisbon District, 2801-951

  • Study site

    Braga, 4710-243

  • Study site

    Guimarães, Braga District, 4835-044

  • Study site

    Lisbon, 1099-023

  • Study site

    Lisbon, 1150-199

  • Study site

    Lisbon, 1400-038

  • Study site

    Lisbon, 1500-650

  • Study site

    Matosinhos Municipality, Porto District, 4464-513

  • Study site

    Porto, 4200-072

  • Study site

    Porto, 4200-319

Other trials in Portugal

Romania10 sites

  • Study site

    Bucharest, 22328

  • Study site

    Bucharest, 41345

  • Study site

    Bucharest, 50659

  • Study site

    Bucharest, 75000

  • Study site

    Cluj-Napoca, 400015

  • Study site

    Craiova, 200347

  • Study site

    Craiova, 200385

  • Study site

    Oradea, 410159

  • Study site

    Ploieşti, 100337

  • Study site

    Târgu Mureş, 540103

Other trials in Romania

Czechia8 sites

  • Study site

    Jablonec nad Nisou, 466 60

  • Study site

    Kolín, 280 00

  • Study site

    Olomouc, 775 20

  • Study site

    Opava, 746 01

  • Study site

    Prague, 120 00

  • Study site

    Prague, 128 08

  • Study site

    Prague, 160 00

  • Study site

    Prague, 180 81

Other trials in Czechia

South Africa8 sites

  • Study site

    Cape Town, 7505

  • Study site

    Cape Town, 7925

  • Study site

    George, Eastern Cape, 6530

  • Study site

    Paarl, Western Cape, 7646

  • Study site

    Port Elizabeth, Eastern Cape, 6045

  • Study site

    Pretoria, Gauteng, 0002

  • Study site

    Pretoria, Gauteng, 0083

  • Study site

    Rondebosch, Western Cape, 7700

Other trials in South Africa

Ukraine8 sites

  • Study site

    Chernivtsi, 58002

  • Study site

    Dnipro, 49102

  • Study site

    Kharkiv, 61037

  • Study site

    Kryvyi Rih, 50048

  • Study site

    Kyiv, 04053

  • Study site

    Kyiv, 2660

  • Study site

    Uzhhorod, 88014

  • Study site

    Zaporizhzhya, 69600

Other trials in Ukraine

Argentina7 sites

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1120AAT

  • Study site

    Córdoba, X5000HXL

  • Study site

    Córdoba, X5004FHP

  • Study site

    Córdoba, X5016KEH

  • Study site

    La Rioja, F5300COE

  • Study site

    San Miguel de Tucumán, Tucumán Province, T4000HXU

  • Study site

    Santa Fe, Santa Fe Province, S3000FFV

Other trials in Argentina

Australia6 sites

  • Study site

    Douglas, Queensland, 4814

  • Study site

    Fitzroy, Victoria, 3065

  • Study site

    Kurralta Park, South Australia, 5037

  • Study site

    Randwick, New South Wales, 2031

  • Study site

    South Brisbane, Queensland, 4101

  • Study site

    St Leonards, New South Wales, 2065

Other trials in Australia

Latvia6 sites

  • Study site

    Daugavpils, LV5401

  • Study site

    Jelgava, LV-3001

  • Study site

    Leipaja, LV-3401

  • Study site

    Riga, LV-1001

  • Study site

    Riga, LV-1002

  • Study site

    Riga, LV-1038

Other trials in Latvia

Turkey (Türkiye)6 sites

  • Study site

    Ankara, 06500

  • Study site

    Istanbul, 34724

  • Study site

    Izmir, 35100

  • Study site

    Izmir, 35340

  • Study site

    Manisa, 45030

  • Study site

    Sivas, 58140

Other trials in Turkey (Türkiye)

Belgium5 sites

  • Study site

    Bonheiden, 2820

  • Study site

    Kortrijk, 8500

  • Study site

    Libramont, 6800

  • Study site

    Liège, 4000

  • Study site

    Sint-Truiden, 3800

Other trials in Belgium

Finland5 sites

  • Study site

    Helsinki, 00290

  • Study site

    Kuopio, 70210

  • Study site

    Seinäjoki, 60220

  • Study site

    Tampere, 33521

  • Study site

    Turku, FIN-20521

Other trials in Finland

Lithuania5 sites

  • Study site

    Kaunas, LT-45434

  • Study site

    Kaunas, LT-50009

  • Study site

    Klaipėda, LT-92288

  • Study site

    Vilnius, LT-08660

  • Study site

    Vilnius, LT-08661

Other trials in Lithuania

Taiwan5 sites

  • Study site

    Kaohsiung City, 807

  • Study site

    Kaoshiung, 81362

  • Study site

    Taichung, 40705

  • Study site

    Taipei, 100

  • Study site

    Taoyuan, 33305

Other trials in Taiwan

Peru4 sites

  • Study site

    La Victoria, Arequipa, 4001

  • Study site

    Lima, 15046

  • Study site

    Lima, 15073

  • Study site

    San Isidro, 15036

Other trials in Peru

Slovakia4 sites

  • Study site

    Bratislava, 851 01

  • Study site

    Bratislava, 851 05

  • Study site

    Martin, 036 59

  • Study site

    Trenčín, 91101

Other trials in Slovakia

Sweden4 sites

  • Study site

    Gothenburg, 413 45

  • Study site

    Örebro, 701 85

  • Study site

    Stockholm, 171 76

  • Study site

    Uppsala, 751 85

Other trials in Sweden

Colombia3 sites

  • Study site

    Floridablanca, Santander Department, 681004

  • Study site

    Medellín, Antioquia, 050034

  • Study site

    Montería, Departamento de Córdoba, 230002

Other trials in Colombia

Serbia3 sites

  • Study site

    Belgrade, 11000

  • Study site

    Belgrade, 11080

  • Study site

    Niš, 18000

Other trials in Serbia

Austria2 sites

  • Study site

    Vienna, 1020

  • Study site

    Vienna, 1090

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Belarus2 sites

  • Study site

    Lesnoy, 223040

  • Study site

    Minsk, 220013

Other trials in Belarus

Bulgaria2 sites

  • Study site

    Sofia, 1680

  • Study site

    Varna, 9000

Other trials in Bulgaria

Estonia1 site

  • Study site

    Tallinn, 13419

Other trials in Estonia

Israel1 site

  • Study site

    Haifa, 35152

Other trials in Israel

About this study

Official title: 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.

Being tested
Darolutamide (Nubeqa, BAY1841788), Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Darolutamide (Nubeqa, BAY1841788)Drug

    Also called ODM-201

    Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.

  • PlaceboDrug

    Matching placebo 2 tablets twice daily with food.

Study groups in NCT02200614
Study groupRoleWhat they receive
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.
Receives: Drug: Darolutamide (Nubeqa, BAY1841788)
PlaceboPlacebo comparatorParticipants received matching placebo 2 tablets twice daily with food.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: From randomization to the time approximately 385 MFS events were observed (approximately 48 months)

Secondary outcomes (8)

  1. Overall Survival - Primary Analysis

    Overall Survival (OS) was defined as the time from randomization to death due to any cause.

    Measured: From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 months)

  2. 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.

    Measured: From randomization until last study treatment (assessed every 4 months) (approximately 48 months)

  3. 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.

    Measured: From randomization until last study treatment (assessed every 4 months) (approximately 48 months)

  4. 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.

    Measured: From randomization until last study treatment (assessed every 4 months) (approximately 48 months)

  5. 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).

    Measured: From randomization of the first subject to the time approximatively 254 death events were observed (approximately 56 months)

  6. 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.

    Measured: From randomization until last study treatment (assessed every 4 months) (approximately 48 months)

  7. 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).

    Measured: From randomization until initiation of first cytotoxic chemotherapy treatment (approximately 59 months)

  8. 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).

    Measured: From randomization until occurrence of first SSE event (approximately 59 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2014 (estimated)
  2. Study start12 Sep 2014
  3. Primary completion3 Sep 2018
  4. Study completion14 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,509 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02200614
Sponsor's protocol ID
17712
Other IDs
2013-003820-36
Acronym
ARAMIS
Status last verified
Jun 2022
First submitted
22 Jul 2014
Last updated
28 Jun 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 41450200

  • Ni 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.

    PubMed 40132221

  • Shore 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.

    PubMed 38394384

  • Fizazi 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.

    PubMed 37660438

  • Carles 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.

    PubMed 37222151

  • Shore 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.

    PubMed 36087070

  • 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.

    PubMed 34797506

  • 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.

    PubMed 33554636

  • 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.

    PubMed 32905676

  • 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.

    PubMed 31571095

  • 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.

    PubMed 30763142

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Darolutamide (Nubeqa, BAY1841788) in people with Prostate Cancer Non-Metastatic and Castration-Resistant, run by Bayer at 404 sites in 36 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 404 sites in United States, Japan, France, Spain, Germany and 31 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metastasis-Free Survival (time frame: From randomization to the time approximately 385 MFS events were observed (approximately 48 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02200614, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.

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