check_circleStudy Completed

Metastatic hormone-sensitive prostate cancer

Bayer Identifier:

17777

ClinicalTrials.gov Identifier:

NCT02799602

EudraCT Number:

2015-002590-38

EU CT Number:

Not Available
Darolutamide in addition to standard androgen deprivation therapy and docetaxel in metastatic hormone–sensitive prostate cancer

Trial purpose

The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - Histologically or cytologically confirmed adenocarcinoma of prostate.
    - Metastatic disease
    - Candidates for ADT and docetaxel.
    - Started ADT with or without first generation anti androgen, but no longer than 12 weeks before randomization
    - An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    - Adequate bone marrow, liver and renal function

  • - Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), other investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer; chemotherapy or immunotherapy for prostate cancer prior to randomization.
    - Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.
    - Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)
    - Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed 5 years before randomization and from which the subject has been disease–free
    - Gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment.
    - Inability to swallow oral medications

Trial summary

Enrollment Goal
1306
Trial Dates
November 2016 - April 2023
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Darolutamide+ADT+docetaxel (BAY1841788)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Roma, 00152, Italy
Completed
Torino, 10043, Italy
Completed
Tel Aviv, 6423906, Israel
Completed
Zrifin, 7030000, Israel
Completed
Barcelona, 08023, Spain
Completed
BRUXELLES - BRUSSEL, 1200, Belgium
Completed
GENT, 9000, Belgium
Completed
Barcelona, 8036, Spain
Withdrawn
Madrid, 28046, Spain
Completed
Córdoba, 14004, Spain
Completed
Sabadell, 08208, Spain
Completed
Brussels, 1070, Belgium
Completed
Berlin, 12203, Germany
Completed
Tübingen, 72076, Germany
Completed
Münster, 48149, Germany
Withdrawn
Köln, 50931, Germany
Completed
Jena, 07747, Germany
Completed
Padova, 35128, Italy
Withdrawn
Arezzo, 52100, Italy
Completed
Milano, 20141, Italy
Completed
Valencia, 46009, Spain
Withdrawn
Dresden, 01307, Germany
Completed
Nürtingen, 72622, Germany
Completed
Rostock, 18107, Germany
Completed
Duarte, 91010, United States
Withdrawn
Syracuse, 13210, United States
Withdrawn
Nashville, 37209, United States
Completed
Boca Raton, 33486, United States
Withdrawn
Philadelphia, 19111-2497, United States
Withdrawn
Denver, 80211, United States
Completed
VILLEJUIF CEDEX, 94805, France
Completed
POITIERS, 86021, France
Completed
Saint Herblain Cedex, 44805, France
Completed
ANGERS CEDEX, 49055, France
Withdrawn
Bydgoszcz, 85-165, Poland
Withdrawn
Wroclaw, 50 - 556, Poland
Completed
Siedlce, 08-110, Poland
Completed
Edmonton, T6G 1Z2, Canada
Completed
Toronto, M4N 3M5, Canada
Completed
Montreal, H2L 4M1, Canada
Completed
Praha 5, 150 06, Czechia
Withdrawn
Hradec Kralove, 500 05, Czechia
Completed
Praha 2, 128 08, Czechia
Completed
Brno, 602 00, Czechia
Completed
Praha 2, 120 00, Czechia
Completed
Haifa, 3109601, Israel
Completed
Petach Tikva, 4941492, Israel
Completed
Holon, 5822012, Israel
Completed
Beer Sheva, 8410101, Israel
Withdrawn
Jerusalem, 9103102, Israel
Completed
Zefat, 1311001, Israel
Completed
Moscow, 125284, Russian Federation
Completed
Omsk, 644013, Russian Federation
Completed
Moscow, 115478, Russian Federation
Completed
St. Petersburg, 197136, Russian Federation
Completed
Barnaul, 656045, Russian Federation
Completed
Novosibirsk, 630099, Russian Federation
Completed
New Orleans, 70112, United States
Completed
Columbus, 43214-2416, United States
Withdrawn
Ephrata, 17522-1761, United States
Withdrawn
Seattle, 98101-2756, United States
Withdrawn
New Hyde Park, 11042, United States
Withdrawn
Gilbert, 85234, United States
Completed
Baltimore, 21231, United States
Completed
Omaha, 68130-5606, United States
Withdrawn
New York, United States
Completed
Columbus, 43210, United States
Completed
Oklahoma City, 73104, United States
Withdrawn
Nashville, 37232-0021, United States
Completed
Towson, 21204, United States
Completed
Greenville, 29607, United States
Completed
Boston, 02111, United States
Withdrawn
Aurora, 80045, United States
Completed
Dallas, 75231, United States
Withdrawn
Concord, 28025, United States
Completed
Tucson, 85724, United States
Completed
PIERRE BENITE, 69495, France
Withdrawn
CAEN CEDEX 5, 14076, France
Withdrawn
PARIS cedex 5, 75248, France
Completed
CERGY PONTOISE, 95303, France
Completed
Varna, 9010, Bulgaria
Completed
Vratsa, 3000, Bulgaria
Completed
Seoul, 6351, Korea, Republic Of
Completed
Seoul, 6273, Korea, Republic Of
Completed
Seoul, 138-736, Korea, Republic Of
Completed
Seoul, 3080, Korea, Republic Of
Completed
Lublin, 20-362, Poland
Completed
Boston, 02114-2696, United States
Withdrawn
Moscow, 119435, Russian Federation
Completed
Taipei, 100, Taiwan
Completed
Taoyuan, 33305, Taiwan
Completed
Taipei, 11217, Taiwan
Completed
Taichung, 40447, Taiwan
Completed
Kaohsiung City, 807377, Taiwan
Completed
Kurralta Park, 5037, Australia
Completed
Helsinki, 00290, Finland
Completed
Kuopio, 70210, Finland
Completed
Oulu, 90220, Finland
Withdrawn
Richmond, 3122, Australia
Completed
London, NW1 2BU, United Kingdom
Completed
Colchester, CO45JR, United Kingdom
Completed
Middlesborough, TS43BW, United Kingdom
Completed
London, SW3 6JJ, United Kingdom
Withdrawn
Oxford, OX3 7LJ, United Kingdom
Completed
Romford, RM7 0AG, United Kingdom
Completed
Seoul, 06591, Korea, Republic Of
Completed
Gwangju, 61469, Korea, Republic Of
Completed
Barcelona, 08003, Spain
Completed
Malaga, 29010, Spain
Completed
Madrid, 28041, Spain
Completed
Daegu, 700721, Korea, Republic Of
Completed
Belfast, BT9 7AB, United Kingdom
Completed
Toronto, M5G 2M9, Canada
Completed
Shanghai, 200000, China
Completed
Nanjing, 210008, China
Completed
Nanjing, 210000, China
Withdrawn
Nedlands, 6009, Australia
Completed
Sofia, 1784, Bulgaria
Completed
Sofia, 1303, Bulgaria
Completed
Pleven, 5809, Bulgaria
Completed
Busan, 47392, Korea, Republic Of
Withdrawn
Englewood, 80113-2766, United States
Completed
Washington, 20007-2113, United States
Completed
Winston-Salem, 27157, United States
Completed
Brno, 656 91, Czechia
Completed
Randwick, 2031, Australia
Withdrawn
Kaohsiung, 833, Taiwan
Completed
Pittsburgh, 15212, United States
Completed
Xi'an, 710061, China
Completed
Tianjin, 300000, China
Completed
Shenyang, 110001, China
Completed
Magdeburg, 39120, Germany
Withdrawn
Homburg, 66421, Germany
Completed
Freiburg, 79106, Germany
Completed
Bologna, 40138, Italy
Withdrawn
St. Petersburg, 197022, Russian Federation
Completed
Reims, 51726, France
Completed
Lodz, 90-302, Poland
Withdrawn
Beijing, 100730, China
Completed
Nanchang, 330006, China
Completed
Myrtle Beach, 29572, United States
Completed
Detroit, 48202, United States
Completed
Charlottesville, 22908, United States
Completed
New York, 10032, United States
Completed
Louisville, 40202, United States
Withdrawn
Seattle, 98109-1023, United States
Withdrawn
Scottsdale, 85259-5452, United States
Withdrawn
Providence, 02906, United States
Completed
Gainesville, 32610-0316, United States
Completed
STRASBOURG, 67033, France
Completed
Changsha, 410013, China
Completed
Beijing, 100730, China
Completed
Guangzhou, 510120, China
Completed
Wuhan, 430079, China
Completed
Shanghai, 200072, China
Completed
Jinan, 250021, China
Completed
HILVERSUM, 1213 XZ, Netherlands
Completed
Los Angeles, 90073-1003, United States
Completed
BRUXELLES - BRUSSEL, 1000, Belgium
Completed
Everett, 98201, United States
Completed
Minato-ku, 105-8471, Japan
Completed
Bunkyo-ku, 113-8431, Japan
Completed
Shinjuku-ku, 162-8543, Japan
Completed
Yokohama, 232-0024, Japan
Completed
Chiba, 260-8677, Japan
Completed
Kashiwa, 277-8577, Japan
Completed
Osaka, 541-8567, Japan
Completed
Osakasayama, 589-8511, Japan
Completed
Kita, 761-0793, Japan
Completed
Sendai, 980-8574, Japan
Completed
Umea, 901 85, Sweden
Completed
Göteborg, 413 45, Sweden
Completed
Uppsala, 751 85, Sweden
Completed
Chelyabinsk, 454048, Russian Federation
Completed
Seoul, 03722, Korea, Republic Of
Completed
Lebanon, 03756, United States
Completed
Rochester, 14642, United States
Completed
Tampa, 33612-9416, United States
Completed
Fairfax, 22031, United States
Completed
Buffalo, 14203, United States
Completed
Seongnam-si, 13620, Korea, Republic Of
Completed
Rybnik, 44-200, Poland
Completed
Hefei City, Anhui Province, 230031, China
Completed
Shanghai, 200092, China
Completed
Shanghai, 200040, China
Completed
Tampere, 33521, Finland
Withdrawn
Poznan, 60-569, Poland
Completed
Hackensack, 07601, United States
Completed
London, W6 8RF, United Kingdom
Completed
CHARLEROI, 6000, Belgium
Completed
Shijiazhuang, 050000, China
Completed
Hangzhou, 310014, China
Completed
Shengyang, 110042, China
Completed
Xiamen, 361003, China
Completed
seoul, 02841, Korea, Republic Of
Completed
Temple, 76508, United States
Withdrawn
Hershey, 17033, United States
Completed
MARSEILLE, 13273, France
Completed
NANCY, 54100, France
Completed
Trento, 38100, Italy
Completed
Lund, 221 85, Sweden
Completed
Jyväskylä, 40620, Finland
Withdrawn
Düsseldorf, 40225, Germany
Withdrawn
Newnan, 30265, United States
Completed
Adelaide, 5000, Australia
Completed
GELEEN, 6162 BG, Netherlands
Withdrawn
NIJMEGEN, 6525 GA, Netherlands
Completed
Den Haag, 2545 AA, Netherlands
Withdrawn
Miami Beach, 33140, United States
Completed
Milwaukee, 53226, United States
Withdrawn
Burlington, 01805, United States
Completed
Billings, 59102, United States
Completed
Atlanta, 30322, United States
Withdrawn
Bari, 70124, Italy
Completed
Wilrijk, 2610, Belgium
Completed
Camp Hill, 17011, United States
Completed
North Charleston, 29406, United States
Withdrawn
México, 14080, Mexico
Completed
Monterrey, 64460, Mexico
Completed
Cuernavaca, 62290, Mexico
Completed
Ciudad de Mexico, 06760, Mexico
Completed
México, D. F., 06760, Mexico
Completed
Stockholm, 17176, Sweden
Withdrawn
Plovdiv, 4004, Bulgaria
Completed
Sofia, 1431, Bulgaria
Completed
Porto Alegre, 90050 170, Brazil
Completed
Curitiba, 81520-060, Brazil
Withdrawn
Sao Paulo, 01308-050, Brazil
Withdrawn
Belo Horizonte, 30150-320, Brazil
Withdrawn
Sao Paulo, 05651-901, Brazil
Completed
Cachoeiro de Itapemirim, 29308-020, Brazil
Completed
São Paulo, 04014-002, Brazil
Completed
Santo André, 09060-650, Brazil
Completed
Salvador, 41253-190, Brazil
Withdrawn
São Paulo, 01246-000, Brazil
Withdrawn
Belo Horizonte, 30130-100, Brazil
Completed
Rio de Janeiro, 22793-080, Brazil
Completed
Rio de Janeiro, 20231-050, Brazil
Completed
Poughkeepsie, 12601, United States
Withdrawn
New Haven, 06520, United States
Completed
Camden, 08143, United States
Completed
Bala Cynwyd, 19004, United States
Completed
Matsuyama, 791-0280, Japan
Completed
Sapporo, 003-0804, Japan
Completed
Kobe, 650-0017, Japan
Completed
Osaka, 545-8586, Japan
Completed
Shanghai, 200080, China
Completed
Wenzhou, 325000, China
Completed
Beijing, 100142, China
Completed
Gyeonggi-do, 11923, Korea, Republic Of
Completed
CLERMONT-FERRAND, 63011, France
Completed
Richmond, 23298-5054, United States
Completed
Stanford, 94305-5820, United States
Completed
Cleveland, 44106, United States
Withdrawn
Houston, 77030, United States
Completed
Chicago, 60611, United States
Completed
Peoria, 61615-7828, United States
Completed
Sakura, 285-8741, Japan
Completed
Hamamatsu, 431-3192, Japan
Completed
Bunkyo-ku, 113-8655, Japan
Completed
Calgary, T2N 4N2, Canada
Completed
Yonago, 683-8504, Japan
Completed
Utsunomiya, 321-0974, Japan
Completed
Kanazawa, 920-8641, Japan
Completed
Chiba, 260-8717, Japan
Withdrawn
Roma, 00161, Italy
Completed
Nagoya, 466-8560, Japan
Completed
Suita, 565-0871, Japan
Completed
Mitaka, 181-8611, Japan
Completed
Koto-ku, 135-8550, Japan
Completed
Bunkyo-ku, 113-8603, Japan
Withdrawn
Mexico, D.F., 14050, Mexico
Completed
Tsu, 514-8507, Japan
Completed
Mikkeli, FIN-50100, Finland
Completed
Warszawa, 02-781, Poland
Completed
Fukuoka, 811-1395, Japan
Completed
Ube, 755-8505, Japan
Completed
Kashihara, 634-8522, Japan
Completed
Miyazaki, 889-1692, Japan
Completed
Shimotsuke, 329-0498, Japan
Completed
Kumamoto, 860-0008, Japan
Completed
Kanazawa, 920-8530, Japan
Completed
Okayama, 700-8558, Japan
Completed
Nakano-ku, 164-8541, Japan
Completed
Shinjuku-ku, 160-8582, Japan
Withdrawn
Changsha, 410011, China
Completed
Waliszew, 05-135, Poland
Completed
Yokohama, 241-8515, Japan
Completed
Hirosaki, 036-8563, Japan
Withdrawn
Durango, 34000, Mexico
Withdrawn
Cuautitlan Izcalli, 54769, Mexico
Completed
Mazatlán, 82110, Mexico
Completed
Jerusalem, 9112001, Israel
Completed
Fitzroy, 3065, Australia
Completed
Parma, 43126, Italy
Completed
Beijing, 100050, China
Completed
Wakayama, 641-8510, Japan
Completed
Nagasaki, 852-8501, Japan
Completed
Tokushima, 770-8503, Japan
Completed
Asahi, 289-2511, Japan
Completed
Santiago de Querétaro, 76000, Mexico
Completed
MONTPELLIER CEDEX, 34298, France
Completed
CRETEIL, 94010, France
Completed
Meguro-ku, 152-8902, Japan
Completed
BESANCON, 25030, France
Completed
Gifu, 500-8717, Japan
Completed
Praha 8, 180 81, Czechia
Completed
Turku, 20520, Finland
Completed
Praha 10, 10034, Czechia
Completed
Glasgow, G12 0YN, United Kingdom
Completed
Gabrovo, 5300, Bulgaria
Completed
Sydney, 2010, Australia
Completed
Hoofddorp, 2134 TM, Netherlands
Completed
AMSTERDAM, 1066 CX, Netherlands
Completed
AMSTERDAM, 1081 HV, Netherlands
Completed
DORDRECHT, 3318 AT, Netherlands
Completed
Charleston, 29414, United States
Completed
Englewood, 07361, United States
Completed
Chandler, 85224, United States
Completed
Braunschweig, 38126, Germany
Completed
Ulm, 89075, Germany
Completed
Barcelona, 08041, Spain
Completed
Palma De Mallorca, 7120, Spain
Completed
Lugo, 27003, Spain
Completed
Cáceres, 10003, Spain
Completed
Erlangen, 91054, Germany
Completed
Tilburg, 5042 AD, Netherlands
Completed
Natal, 59062-000, Brazil
Completed
Verona, 37134, Italy
Withdrawn
Madrid, 28007, Spain
Completed
Beijing, 100034, China
Completed
Yantai, 264000, China
Completed
Wuhan, 430030, China
Completed
Tianjin, 300052, China
Completed
Shanghai, 200032, China
Completed
Zhengzhou, 450000, China
Completed
Chongqing, 400030, China
Withdrawn
Antwerp, 2020, Belgium
Withdrawn
Stockholm, 118 83, Sweden
Completed
Changchun City, 130061, China
Completed
Salt Lake City, 84112, United States
Completed
Bronx, 10467-2490, United States
Completed
Boston, 02215, United States
Completed
Chelyabinsk, 454087, Russian Federation
Completed
Novara, 28100, Italy
Completed
SAINT-GREGOIRE, 35760, France
Withdrawn
PARIS, 75674, France
Completed
Bordeaux Cedex, 33076, France
Completed
St. Petersburg, 188663, Russian Federation
Completed
St. Petersburg, 194017, Russian Federation
Completed
Beijing, 100142, China
Completed
NAMUR, 5000, Belgium
Completed
Beverly Hills, 90211-1850, United States
Completed
Jinan, 250012, China
Completed
Charleston, 29401-5799, United States
Completed
BREST, 29200, France
Withdrawn
DIJON, 21000, France
Withdrawn
SAINT MANDE, 94160, France
Completed
Albuquerque, 87109, United States
Completed
Beijing, 100083, China
Completed
Hangzhou, 310009, China
Completed
Madrid, 28034, Spain
Completed
Kettering, 45409-1328, United States

Primary Outcome

  • OS from date of randomization until death from any cause
    Overall survival (OS) was defined as the time from the date of randomization until death from any cause. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. Long-term (Survival) follow-up period: After Active follow-up, patients continued to be contacted approximately every 12 weeks by phone. The end of the Survival follow-up period was defined as when the patient died, was lost to follow-up, withdrew consent, or at the end-of-study.
    date_rangeTime Frame:
    From randomization of the first subject until death from any cause up to the time 533 OS events were reached (approximately 59 months)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with TEAEs
    TEAEs = Treatment-emergent adverse events Treatment-emergent AEs (TEAEs) were defined as any event(s) arising or worsening after the first dose of darolutamide or placebo, until 30 days after the last dose of darolutamide or placebo administration.
    date_rangeTime Frame:
    From the first dose of darolutamide or placebo until cut-off date for the final analysis planned as 30 JUN 2023 (approximately 79 months)
  • Time to castration–resistant prostate cancer (CRPC)
    Time to castration-resistant prostate cancer was defined as the time from randomization to the first occurrence of one of the following events: PSA progression, Radiological progression by bone lesions, or Radiological progression by soft tissue and visceral lesions. Treatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. NA = Value cannot be estimated due to censored data
    date_rangeTime Frame:
    From randomization of the first subject to the first occurrence of an CRPC event up to approximately 59 months
  • Time to pain progression
    Time to pain progression was defined as the time from randomization to the first date a patient experienced pain progression. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.
    date_rangeTime Frame:
    From randomization of the first subject to the first occurrence of an pain progression event up to approximately 59 months
  • Symptomatic skeletal event free survival (SSE–FS)
    Symptomatic skeletal event-free survival (SSE-FS) was defined as the time from randomization to the first occurrence of an SSE or death from any cause, whichever occurred first. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. NA = Value cannot be estimated due to censored data
    date_rangeTime Frame:
    From randomization of the first subject to the first occurrence of an SSE event or death from any cause, whichever occurred first up to approximately 59 months
  • Time to first symptomatic skeletal event (SSE)
    Time to the first SSE was defined as the time from randomization to the first occurrence of an SSE. Identical to the definition used for SSE-FS. Death was not considered as an event in this endpoint. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.
    date_rangeTime Frame:
    From randomization of the first subject to the first occurrence of an SSE event up to approximately 59 months
  • Time to initiation of subsequent antineoplastic therapy
    Time to initiation of subsequent systemic antineoplastic therapy was defined as the time from randomization to the initiation of first subsequent systemic antineoplastic therapy. Treatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. NA = Value cannot be estimated due to censored data
    date_rangeTime Frame:
    From randomization of the first subject to the initiation of first subsequent systemic antineoplastic therapy up to approximately 59 months
  • Time to worsening of disease–related physical symptoms
    Time to worsening of disease-related physical symptoms was defined as the time from randomization to the first date a patient experienced an increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.
    date_rangeTime Frame:
    From randomization of the first subject to the first increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire up to approximately 59 months
  • Time to initiation of opioid use for ≥7 consecutive days
    Time to the initiation of opioid use for ≥7 consecutive days was defined as the time fromrandomization to the date of the first opioid use for ≥7 consecutive days. Data of opioid use related to cancer pain was included in the analysis, and opioid use for non-malignant causes was excluded. Treatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.
    date_rangeTime Frame:
    From randomization of the first subject to the first opioid use for ≥7 consecutive days up to approximately 59 months

Trial design

A randomized, double-blind, placebo controlled Phase III study of darolutamide (ODM-201) versus placebo in addition to standard androgen deprivation therapy and docetaxel in patients with metastatic hormone sensitive prostate cancer
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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