check_circleStudy Completed
Metastatic hormone-sensitive prostate cancer
Bayer Identifier:
17777
ClinicalTrials.gov Identifier:
EudraCT Number:
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
MaleAge
18 - N/ATrial summary
Enrollment Goal
1306Trial Dates
November 2016 - April 2023Phase
Phase 3Could I Receive a placebo
YesProducts
Darolutamide+ADT+docetaxel (BAY1841788)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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Withdrawn | Madrid, 28046, Spain | |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Withdrawn | Köln, 50931, Germany | |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Withdrawn | Arezzo, 52100, Italy | |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Withdrawn | Dresden, 01307, Germany | |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Withdrawn | Syracuse, 13210, United States | |
Withdrawn | Nashville, 37209, United States | |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Withdrawn | Philadelphia, 19111-2497, United States | |
Withdrawn | Denver, 80211, United States | |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Withdrawn | Bydgoszcz, 85-165, Poland | |
Withdrawn | Wroclaw, 50 - 556, Poland | |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 causeOverall 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_encryptionNoSafety Issue:
Secondary Outcome
- Number of participants with TEAEsTEAEs = 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 datadate_rangeTime Frame:From randomization of the first subject to the first occurrence of an CRPC event up to approximately 59 months
- Time to pain progressionTime 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 datadate_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 therapyTime 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 datadate_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 symptomsTime 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 daysTime 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
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2