Trial Condition(s):
Prostate Cancer Non-Metastatic
Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer (ARAMIS)
Bayer Identifier:
17712
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
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Locations Investigative Site Tampere, Finland, 33521 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Investigative Site Manacor, Spain, 07500 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Elche, Spain, 03203 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Terrassa, Spain, 8221 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Barcelona, Spain, 08023 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Sabadell, Spain, 08208 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Sevilla, Spain, 41013 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Alcorcón, Spain, 28922 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Granada, Spain, 18012 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Sevilla, Spain, 41009 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Madrid, Spain, 28007 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Salamanca, Spain, 37007 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Valencia, Spain, 46009 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Cádiz, Spain, 11009 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Barcelona, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Bilbao, Spain, 48013 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Scunthorpe, United Kingdom, DN15 7BH | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Dudley, United Kingdom, DY1 2HQ | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Martin, Slovakia, 036 59 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site St Leonards, Australia, 2065 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Stockholm, Sweden, 171 76 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Örebro, Sweden, 701 85 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Göteborg, Sweden, 413 45 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Uppsala, Sweden, 751 85 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Randwick, Australia, 2031 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Douglas, Australia, 4814 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site South Brisbane, Australia, 4101 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Kurralta Park, Australia, 5037 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Porto, Portugal, 4200-319 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Almada, Portugal, 2801-951 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Guimaraes, Braga, Portugal, 4835-044 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Lisboa, Portugal, 1400-038 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Lisboa, Portugal, 1099-023 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Matosinhos, Portugal, 4464-513 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Lisboa, Portugal, 1150-199 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Braga, Portugal, 4710-243 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Lisboa, Portugal, 1500-650 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Bratislava, Slovakia, 851 01 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Trencin, Slovakia, 91101 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Bratislava, Slovakia, 851 05 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Bucuresti, Romania, 22328 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Bucuresti, Romania, 75000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Targu-Mures, Romania, 540103 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Bucuresti, Romania, 50659 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Bucuresti, Romania, 41345 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Oradea, Romania, 410159 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Pretoria, South Africa, 0083 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site George, South Africa, 6530 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Pretoria, South Africa, 0002 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Paarl, South Africa, 7646 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Minsk, Belarus, 220013 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Lesnoy, Belarus, 223040 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Rondebosch, South Africa, 7700 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Cape Town, South Africa, 7925 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Cape Town, South Africa, 7505 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Port Elizabeth, South Africa, 6045 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Sofia, Bulgaria, 1680 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Varna, Bulgaria, 9000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Praha 6, Czech Republic, 160 00 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Olomouc, Czech Republic, 779 00 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Praha 2, Czech Republic, 128 08 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Jablonec nad Nisou, Czech Republic, 46601 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Opava, Czech Republic, 746 01 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Kolin, Czech Republic, 280 00 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Praha 2, Czech Republic, 120 00 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Praha 8, Czech Republic, 180 81 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Madrid, Spain, 28041 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Berlin, Germany, 12203 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Holzminden, Germany, 37603 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Emmendingen, Germany, 79312 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Nürtingen, Germany, 72622 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Mühlheim, Germany, 45468 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Magdeburg, Germany, 39120 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Marburg, Germany, 35039 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Hamburg, Germany, 20246 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Hagenow, Germany, 19230 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Münster, Germany, 48149 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Hamburg, Germany, 22081 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Köln, Germany, 50937 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Reutlingen, Germany, 72764 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Düsseldorf, Germany, 40225 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Kirchheim unter Teck, Germany, 73230 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Zirndorf, Germany, 90513 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Muehlacker, Germany, 75417 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Wuppertal, Germany, 42103 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Omaha, United States, 68130 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Boca Raton, United States, 33486 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Porto, Portugal, 4200-072 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Buenos Aires, Argentina, C1120AAT | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site BESANCON, France, 25030 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Toronto, Canada, M5G 2M9 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Torino, Italy, 10043 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Lugo, Spain, 27003 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Madrid, Spain, 28046 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Valencia, Spain, 46015 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Charlotte, United States, 28277 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Royal Oak, United States, 48073 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Montería, Colombia, 230002 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Medellín, Colombia, 050034 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Floridablanca, Colombia, 681004 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Torino, Italy, 10060 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Palermo, Italy, 90127 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Burlington, Canada, L7N 3V2 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Vilnius, Lithuania, LT-08661 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Klaipeda, Lithuania, LT-92288 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Vilnius, Lithuania, LT-08660 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Kaunas, Lithuania, LT-50009 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Kaunas, Lithuania, LT-45434 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Kryvyi Rih, Ukraine, 50048 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Belo Horizonte, Brazil, 30150-320 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Palma de Mallorca, Spain, 07120 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Córdoba, Spain, 14004 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Arezzo, Italy, 52100 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Roma, Italy, 00189 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Sapporo, Japan, 060-8543 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Sendai, Japan, 981-8563 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Maebashi, Japan, 371-8511 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Utsunomiya, Japan, 321-0974 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Chiba, Japan, 260-8717 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Sagamihara, Japan, 252-0375 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Yokosuka, Japan, 238-8558 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Yokohama, Japan, 232-0024 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Mitaka, Japan, 181-8611 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Itabashi-ku, Japan, 173-0015 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Nakano-ku, Japan, 164-8541 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Shinjuku-ku, Japan, 160-8582 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Sumida-ku, Japan, 130-8587 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Bunkyo-ku, Japan, 113-8603 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Bunkyo-ku, Japan, 113-8431 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Minato-ku, Japan, 105-8471 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Toyama, Japan, 930-0194 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Kanazawa, Japan, 920-8530 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Fukui, Japan, 910-8526 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Ueda, Japan, 386-8610 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Hamamatsu, Japan, 431-3192 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Nagoya, Japan, 466-8560 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Kyoto, Japan, 602-8566 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Osaka, Japan, 541-8567 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Osaka, Japan, 558-8558 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Osaka, Japan, 545-8586 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Kobe, Japan, 650-0047 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Kashihara, Japan, 634-8522 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Okayama, Japan, 700-8558 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Hiroshima, Japan, 730-8518 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Otake, Japan, 739-0696 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Ube, Japan, 755-8505 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Kurume, Japan, 839-0863 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Nagasaki, Japan, 852-8511 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Yufu, Japan, 879-5593 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Kashiwa, Japan, 277-8577 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Koriyama, Japan, 963-8563 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Wako, Japan, 351-0102 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Higashiibaraki, Japan, 311-3193 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Osakasayama, Japan, 589-8511 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Nagasaki, Japan, 852-8501 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Craiova, Romania, 200385 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Cluj-Napoca, Romania, 400015 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Craiova, Romania, 200542 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Ploiesti, Romania, 100337 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site St. Petersburg, Russia, 194017 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site St. Petersburg, Russia, 191014 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Orenburg, Russia, 460021 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Incheon, South Korea, 21565 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Daegu, South Korea, 41404 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Dartford, United Kingdom, DA2 8DA | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Barretos/SP, Brazil, 14784-400 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Taoyuan, Taiwan, China, 33305 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Bath, United Kingdom, BA1 3NG | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Wichita, United States, 67226 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Omaha, United States, 68114 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site DIJON, France, 21000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site LIMOGES CEDEX, France, 87042 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site MONTPELLIER CEDEX, France, 34295 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Tallinn, Estonia, 13419 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Orlando, United States, 32803 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Los Angeles, United States, 90073-1003 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Frankfurt, Germany, 60590 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Lebanon, United States, 03756 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Fairfax, United States, 22031 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site St. Petersburg, Russia, 194354 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site CERGY PONTOISE, France, 95303 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Recife, Brazil, 50070-550 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Salvador, Brazil, 40050-410 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Uberlandia, Brazil, 38408-150 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Sorocaba, Brazil, 18035-300 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Laguna Hills, United States, 92653 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Richmond, United States, 23235 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Gahanna, United States, 43230 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site STRASBOURG, France, 67000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site SAINT MANDE, France, 94160 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Herzberg Am Harz, Germany, 37412 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Syracuse, United States, 13210 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Malaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Jerez de la Frontera, Spain, 11407 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site CAEN cedex 05, France, 14076 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Calgary, Canada, T2V 1P9 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Tucson, United States, 85704 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Boston, United States, 02114 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site West Des Moines, United States, 50266 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Voorhees, United States, 08043 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Glasgow, United Kingdom, G12 0YN | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Moscow, Russia, 117997 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Daegu, South Korea, 42601 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site BORDEAUX CEDEX, France, 33076 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Daugavpils, Latvia, LV5401 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Investigative Site Middleburg Heights, United States, 44130 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Locations Investigative Site Baltimore, United States, 21204 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Metastasis-Free SurvivalMetastasis-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)Timeframe: From randomization to the time approximately 385 MFS events were observed (approximately 48 months)
Secondary Outcome
- Overall Survival - Primary analysisOverall Survival (OS) was defined as the time from randomization to death due to any cause.Timeframe: From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 months)
- Time to pain progression - Primary analysisTime 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.Timeframe: From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
- Time to initiation of first cytotoxic chemotherapy for prostate cancer - Primary analysisThe time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle.Timeframe: From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
- Time to first symptomatic skeletal event (SSE) - Primary analysisThe time to the first SSE was defined as the time from randomization to the occurrence of the first SSE.Timeframe: From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
- Overall Survival - Final analysisOverall 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).Timeframe: From randomization of the first subject to the time approximatively 254 death events were observed (approximately 56 months)
- Time to pain progression - Final analysisFor 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.Timeframe: From randomization until last study treatment (assessed every 4 months) (approximately 48 months)
- Time to initiation of first cytotoxic chemotherapy for prostate cancer - Final analysisThe 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).Timeframe: From randomization until initiation of first cytotoxic chemotherapy treatment (approximately 59 months)
- Time to first symptomatic skeletal event (SSE) - Final analysisThe 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).Timeframe: From randomization until occurrence of first SSE event (approximately 59 months)
Additional Information
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