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T1  - Safety and Antitumour Activity of ODM-201(BAY-1841788) in Castration-resistant, CYP17 Inhibitor-naïve Prostate Cancer: Results from Extended Follow-up of the ARADES Trial 
SN  -  /  
UR  - http://hdl.handle.net/10138/299332 
T3  -  
A1  - Fizazi, Karim; Massard, Christophe; Bono, P.; Kataja, Vesa; James, Nicholas; Tammela, T.L.; Joensuu, H.; Aspegren, John; Mustonen, M. 
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Y1  - 2017 
LA  - eng 
AB  - Background: Patients with castration-resistant prostate cancer (CRPC) had extended responses to the androgen receptor antagonist ODM-201, in phase 1/2 studies. Objective: To evaluate the safety and antitumour activity of prolonged ODM-201 treatment in patients with CRPC. Design, setting, and participants: The ARADES trial was a multicentre phase 1 (dose escalation) and phase 2 (dose expansion) trial; 134 patients with CRPC were stratified by previous chemotherapy to receive ODM-201. This paper r... 
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KW  - cytochrome P450 family 17; darolutamide; prostate specific antigen; antiandrogen; pyrazole derivative; steroid 17alpha monooxygenase, adult; advanced cancer; aged; anemia; antineoplastic activity; arthralgia; Article; asthenia; backache; cancer chemotherapy; castration resistant prostate cancer; clinical study; cohort analysis; confidence interval; constipation; controlled study; decreased appetite; diarrhea; disease course; drug dose escalation; drug safety; drug tolerability; drug withdrawal; fatigue; flatulence; follow up; gynecomastia; headache; hot flush; human; lymphedema; major clinical study; male; multicenter study; myalgia; nausea; phase 1 clinical trial; phase 2 clinical trial; randomized controlled trial; Staphylococcus infection; treatment duration; treatment response; very elderly; antagonists and inhibitors; clinical trial; disease exacerbation; dose response; drug administration; middle aged; treatment outcome, Aged; Aged, 80 and over; Androgen Antagonists; Disease Progression; Dose-Response Relationship, Drug; Drug Administration Schedule; Humans; Male; Middle Aged; Prostatic Neoplasms, Castration-Resistant; Pyrazoles; Steroid 17-alpha-Hydroxylase; Treatment Outcome; 3122 Cancers 
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