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

NCT ID: NCT02200614

Last Updated: 2022-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1509 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-12
• Study Completion Date: 2021-06-14

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.

Conditions

Prostate Cancer Non-Metastatic; Castration-Resistant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Darolutamide (Nubeqa, BAY1841788)

Intervention Type: DRUG

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

Placebo

Participants received matching placebo 2 tablets twice daily with food.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo 2 tablets twice daily with food.

Interventions

Darolutamide (Nubeqa, BAY1841788)

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

Intervention Type: DRUG

Placebo

Matching placebo 2 tablets twice daily with food.

Intervention Type: DRUG

Other Intervention Names

ODM-201

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Homewood, Alabama, United States

Anchorage, Alaska, United States

Tucson, Arizona, United States

Fountain Valley, California, United States

La Jolla, California, United States

Laguna Hills, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

San Diego, California, United States

Whittier, California, United States

Denver, Colorado, United States

Denver, Colorado, United States

Parker, Colorado, United States

Boca Raton, Florida, United States

Orlando, Florida, United States

Port Saint Lucie, Florida, United States

Coeur d'Alene, Idaho, United States

Chicago, Illinois, United States

Evanston, Illinois, United States

Springfield, Illinois, United States

Greenwood, Indiana, United States

Indianapolis, Indiana, United States

Jeffersonville, Indiana, United States

West Des Moines, Iowa, United States

Wichita, Kansas, United States

New Orleans, Louisiana, United States

Annapolis, Maryland, United States

Baltimore, Maryland, United States

Salisbury, Maryland, United States

Boston, Massachusetts, United States

Grand Rapids, Michigan, United States

Royal Oak, Michigan, United States

Omaha, Nebraska, United States

Omaha, Nebraska, United States

Lebanon, New Hampshire, United States

Voorhees Township, New Jersey, United States

Syracuse, New York, United States

The Bronx, New York, United States

The Bronx, New York, United States

Asheboro, North Carolina, United States

Charlotte, North Carolina, United States

Canton, Ohio, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Gahanna, Ohio, United States

Middleburg Heights, Ohio, United States

Oklahoma City, Oklahoma, United States

Bala-Cynwyd, Pennsylvania, United States

Myrtle Beach, South Carolina, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

Fairfax, Virginia, United States

Richmond, Virginia, United States

Virginia Beach, Virginia, United States

Wheeling, West Virginia, United States

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Santa Fé, Santa Fe Province, Argentina

San Miguel de Tucumán, Tucumán Province, Argentina

Córdoba, , Argentina

Córdoba, , Argentina

Córdoba, , Argentina

La Rioja, , Argentina

Randwick, New South Wales, Australia

St Leonards, New South Wales, Australia

Douglas, Queensland, Australia

South Brisbane, Queensland, Australia

Kurralta Park, South Australia, Australia

Fitzroy, Victoria, Australia

Vienna, , Austria

Vienna, , Austria

Lesnoy, , Belarus

Minsk, , Belarus

Bonheiden, , Belgium

Kortrijk, , Belgium

Libramont, , Belgium

Liège, , Belgium

Sint-Truiden, , Belgium

Fortaleza, Ceará, Brazil

Salvador, Estado de Bahia, Brazil

Goiânia, Goiás, Brazil

Belo Horizonte, Minas Gerais, Brazil

Juiz de Fora, Minas Gerais, Brazil

Uberlândia, Minas Gerais, Brazil

Curitiba, Paraná, Brazil

Recife, Pernambuco, Brazil

Passo Fundo, Rio Grande do Sul, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Itajaí, Santa Catarina, Brazil

Barretos, São Paulo, Brazil

Jaú, São Paulo, Brazil

Ribeirao Preto - SP, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

Sorocaba, São Paulo, Brazil

Sofia, , Bulgaria

Varna, , Bulgaria

Calgary, Alberta, Canada

Halifax, Nova Scotia, Canada

Burlington, Ontario, Canada

Hamilton, Ontario, Canada

Kingston, Ontario, Canada

London, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Granby, Quebec, Canada

Pointe-Claire, Quebec, Canada

Medellín, Antioquia, Colombia

Montería, Departamento de Córdoba, Colombia

Floridablanca, Santander Department, Colombia

Jablonec nad Nisou, , Czechia

Kolín, , Czechia

Olomouc, , Czechia

Opava, , Czechia

Prague, , Czechia

Prague, , Czechia

Prague, , Czechia

Prague, , Czechia

Tallinn, , Estonia

Helsinki, , Finland

Kuopio, , Finland

Seinäjoki, , Finland

Tampere, , Finland

Turku, , Finland

Angers, , France

Bayonne, , France

Besançon, , France

Bordeaux, , France

Caen, , France

Cergy-Pontoise, , France

Clermont-Ferrand, , France

Créteil, , France

Dijon, , France

La Roche-sur-Yon, , France

Limoges, , France

Montpellier, , France

Montpellier, , France

Nancy, , France

Nantes, , France

Paris, , France

Paris, , France

Pierre-Bénite, , France

Poitiers, , France

Reims, , France

Rennes, , France

Rouen, , France

Saint-Mandé, , France

Strasbourg, , France

Suresnes, , France

Tours, , France

Villejuif, , France

Emmendingen, Baden-Wurttemberg, Germany

Kirchheim unter Teck, Baden-Wurttemberg, Germany

Mühlacker, Baden-Wurttemberg, Germany

Nürtingen, Baden-Wurttemberg, Germany

Reutlingen, Baden-Wurttemberg, Germany

Tübingen, Baden-Wurttemberg, Germany

Zirndorf, Bavaria, Germany

Frankfurt am Main, Hesse, Germany

Marburg, Hesse, Germany

Herzberg am Harz, Lower Saxony, Germany

Holzminden, Lower Saxony, Germany

Hagenow, Mecklenburg-Vorpommern, Germany

Cologne, North Rhine-Westphalia, Germany

Düsseldorf, North Rhine-Westphalia, Germany

Mülheim, North Rhine-Westphalia, Germany

Münster, North Rhine-Westphalia, Germany

Wuppertal, North Rhine-Westphalia, Germany

Mainz, Rhineland-Palatinate, Germany

Dresden, Saxony, Germany

Magdeburg, Saxony-Anhalt, Germany

Berlin, , Germany

Hamburg, , Germany

Hamburg, , Germany

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Debrecen, , Hungary

Győr, , Hungary

Nyíregyháza, , Hungary

Szeged, , Hungary

Szekszárd, , Hungary

Szolnok, , Hungary

Zalaegerszeg, , Hungary

Haifa, , Israel

Chieti, Abruzzo, Italy

Lecce, Apulia, Italy

Catanzaro, Calabria, Italy

Napoli, Campania, Italy

Forlì Cesena, Emilia-Romagna, Italy

Modena, Emilia-Romagna, Italy

Parma, Emilia-Romagna, Italy

Rome, Lazio, Italy

Rome, Lazio, Italy

Turin, Piedmont, Italy

Turin, Piedmont, Italy

Messina, Sicily, Italy

Palermo, Sicily, Italy

Arezzo, Tuscany, Italy

Nagoya, Aichi-ken, Japan

Kashiwa, Chiba, Japan

Kurume, Fukuoka, Japan

Kōriyama, Fukushima, Japan

Maebashi, Gunma, Japan

Ōtake, Hiroshima, Japan

Sapporo, Hokkaido, Japan

Kobe, Hyōgo, Japan

Higashiibaraki, Ibaraki, Japan

Kanazawa, Ishikawa-ken, Japan

Sagamihara, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Yokosuka, Kanagawa, Japan

Sendai, Miyagi, Japan

Ueda, Nagano, Japan

Kashihara, Nara, Japan

Yufu, Oita Prefecture, Japan

Sayama, Osaka, Japan

Wako, Saitama, Japan

Hamamatsu, Shizuoka, Japan

Utsunomiya, Tochigi, Japan

Bunkyo-ku, Tokyo, Japan

Bunkyo-ku, Tokyo, Japan

Itabashi-ku, Tokyo, Japan

Minato-ku, Tokyo, Japan

Mitaka, Tokyo, Japan

Nakano-ku, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Sumida-ku, Tokyo, Japan

Ube, Yamaguchi, Japan

Chiba, , Japan

Fukui, , Japan

Hiroshima, , Japan

Kyoto, , Japan

Nagasaki, , Japan

Nagasaki, , Japan

Okayama, , Japan

Osaka, , Japan

Osaka, , Japan

Osaka, , Japan

Toyama, , Japan

Daugavpils, , Latvia

Jelgava, , Latvia

Leipaja, , Latvia

Riga, , Latvia

Riga, , Latvia

Riga, , Latvia

Kaunas, , Lithuania

Kaunas, , Lithuania

Klaipėda, , Lithuania

Vilnius, , Lithuania

Vilnius, , Lithuania

La Victoria, Arequipa, Peru

Lima, , Peru

Lima, , Peru

San Isidro, , Peru

Elblag, , Poland

Gdansk, , Poland

Lodz, , Poland

Lublin, , Poland

Otwock, , Poland

Rzeszów, , Poland

Siedlce, , Poland

Warsaw, , Poland

Warsaw, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Guimarães, Braga District, Portugal

Almada, Lisbon District, Portugal

Matosinhos Municipality, Porto District, Portugal

Braga, , Portugal

Lisbon, , Portugal

Lisbon, , Portugal

Lisbon, , Portugal

Lisbon, , Portugal

Porto, , Portugal

Porto, , Portugal

Bucharest, , Romania

Bucharest, , Romania

Bucharest, , Romania

Bucharest, , Romania

Cluj-Napoca, , Romania

Craiova, , Romania

Craiova, , Romania

Oradea, , Romania

Ploieşti, , Romania

Târgu Mureş, , Romania

Chelyabinsk, , Russia

Ivanovo, , Russia

Kazan', , Russia

Krasnoyarsk, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Nizhny Novgorod, , Russia

Novosibirsk, , Russia

Obninsk, , Russia

Omsk, , Russia

Orenburg, , Russia

Pyatigorsk, , Russia

Rostov-on-Don, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Saratov, , Russia

Tyumen, , Russia

Ufa, , Russia

Vladimir, , Russia

Belgrade, , Serbia

Belgrade, , Serbia

Niš, , Serbia

Bratislava, , Slovakia

Bratislava, , Slovakia

Martin, , Slovakia

Trenčín, , Slovakia

George, Eastern Cape, South Africa

Port Elizabeth, Eastern Cape, South Africa

Pretoria, Gauteng, South Africa

Pretoria, Gauteng, South Africa

Paarl, Western Cape, South Africa

Rondebosch, Western Cape, South Africa

Cape Town, , South Africa

Cape Town, , South Africa

Gwangju, Gwangju Gwang''yeogsi, South Korea

Cheongju-si, North Chungcheong, South Korea

Seoul, Seoul Teugbyeolsi, South Korea

Seoul, Seoul Teugbyeolsi, South Korea

Daegu, , South Korea

Daegu, , South Korea

Incheon, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Elche, Alicante, Spain

Cadiz, Andalusia, Spain

L'Hospitalet de Llobregat, Barcelona, Spain

Sabadell, Barcelona, Spain

Terrassa, Barcelona, Spain

Jerez de la Frontera, Cádiz, Spain

Manacor, Illes Baleares, Spain

Palma de Mallorca, Illes Baleares, Spain

Alcorcón, Madrid, Spain

Bilbao, Vizcaya, Spain

Barcelona, , Spain

Barcelona, , Spain

Córdoba, , Spain

Granada, , Spain

Lugo, , Spain

Madrid, , Spain

Madrid, , Spain

Madrid, , Spain

Madrid, , Spain

Málaga, , Spain

Salamanca, , Spain

Seville, , Spain

Seville, , Spain

Valencia, , Spain

Valencia, , Spain

Valencia, , Spain

Gothenburg, , Sweden

Örebro, , Sweden

Stockholm, , Sweden

Uppsala, , Sweden

Kaohsiung City, , Taiwan

Kaoshiung, , Taiwan

Taichung, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Ankara, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Izmir, , Turkey (Türkiye)

Izmir, , Turkey (Türkiye)

Manisa, , Turkey (Türkiye)

Sivas, , Turkey (Türkiye)

Chernivtsi, , Ukraine

Dnipro, , Ukraine

Kharkiv, , Ukraine

Kryvyi Rih, , Ukraine

Kyiv, , Ukraine

Kyiv, , Ukraine

Uzhhorod, , Ukraine

Zaporizhzhya, , Ukraine

Reading, Berkshire, United Kingdom

Llanelli, Carmarthenshire, United Kingdom

Romford, Essex, United Kingdom

Stevenage, Hertfordshire, United Kingdom

Dartford, Kent, United Kingdom

Maidstone, Kent, United Kingdom

Preston, Lancashire, United Kingdom

Bebington, Merseyside, United Kingdom

Scunthorpe, North East Lincolnshire, United Kingdom

Bath, Somerset, United Kingdom

Stoke-on-Trent, Staffordshire, United Kingdom

Dudley, West Midlands, United Kingdom

Huddersfield, West Yorkshire, United Kingdom

Wakefield, West Yorkshire, United Kingdom

Cardiff, , United Kingdom

Glasgow, , United Kingdom

London, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belarus; Belgium; Brazil; Bulgaria; Canada; Colombia; Czechia; Estonia; Finland; France; Germany; Hungary; Israel; Italy; Japan; Latvia; Lithuania; Peru; Poland; Portugal; Romania; Russia; Serbia; Slovakia; South Africa; South Korea; Spain; Sweden; Taiwan; Turkey (Türkiye); Ukraine; United Kingdom

References

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

2013-003820-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17712

Identifier Type: -

Identifier Source: org_study_id