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

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Fizazi , K , Massard , C , Bono , P , Kataja , V , James , N , Tammela , T L , Joensuu , H , Aspegren , J & Mustonen , M 2017 , ' 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 ' , European Urology Focus , vol. 3 , no. 6 , pp. 606-614 .

Title: 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
Author: Fizazi, Karim; Massard, Christophe; Bono, P.; Kataja, Vesa; James, Nicholas; Tammela, T.L.; Joensuu, H.; Aspegren, John; Mustonen, M.
Contributor organization: Translational Cancer Biology (TCB) Research Programme
Department of Oncology
Heikki Joensuu / Principal Investigator
University Management
Research Programs Unit
The National Library of Finland, Research Library
HUS Comprehensive Cancer Center
Date: 2017
Language: eng
Number of pages: 9
Belongs to series: European Urology Focus
ISSN: 2405-4569
Abstract: 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 reports extended follow-up in CYP17 inhibitor (CYP17i)-naïve patients. Intervention: Patients (n = 77) received oral ODM-201 twice daily at daily doses of 200–1800 mg. Outcome measurements and statistical analysis: Safety, measured as the occurrence of adverse events (AEs), prostate-specific antigen (PSA), and radiographic progression. Results and limitations: The safety profile of extended ODM-201 treatment (median treatment duration 8.2 mo, 95% confidence interval [CI] 5.6–11.0) was consistent with that reported at the time of the original data cutoff in the main ARADES trial, with no unexpected safety concerns over time. The majority of AEs (61.1%) were mild (grade 1); the most common AE was fatigue/asthenia (35.1% of patients), with no clear relationship to ODM-201. Median time to PSA progression was 25.2 mo (95% CI 11.3–25.2) for chemotherapy-naïve men and not reached (NR; 95% CI 5.5–NR) for chemotherapy-pretreated patients; a trend for improved antitumour response was observed for chemotherapy-naïve patients. The median time to radiographic progression was longer for chemotherapy-naïve (14.0 mo, 95% CI 8.1–33.3) than for chemotherapy-pretreated (7.2 mo, 95% CI 2.7–11.0) patients. Conclusions: Prolonged exposure to ODM-201 was well tolerated, with no additional safety concerns; disease suppression was sustained, especially in chemotherapy-naïve patients. These data support further development of ODM-201 in men with CYP17i-naïve CRPC. Patient summary: Extended ODM-201 therapy was well tolerated, with beneficial antitumour activity in men with advanced prostate cancer, indicating that ODM-201 may represent a new active treatment for men with CRPC. This extension trial is registered at ( under identification number NCT01429064. Extended ODM-201 therapy showed encouraging antitumour activity in both chemotherapy-naïve and chemotherapy-treated men with metastatic castration-resistant prostate cancer (CRPC). Continued treatment with ODM-201 was well tolerated, with no unexpected safety concerns, and may represent a new, effective treatment option for men with CRPC. © 2017 European Association of Urology
Subject: cytochrome P450 family 17
prostate specific antigen
pyrazole derivative
steroid 17alpha monooxygenase, adult
advanced cancer
antineoplastic activity
cancer chemotherapy
castration resistant prostate cancer
clinical study
cohort analysis
confidence interval
controlled study
decreased appetite
disease course
drug dose escalation
drug safety
drug tolerability
drug withdrawal
follow up
hot flush
major clinical study
multicenter study
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
Middle Aged
Prostatic Neoplasms, Castration-Resistant
Steroid 17-alpha-Hydroxylase
Treatment Outcome
3122 Cancers
Peer reviewed: Yes
Rights: cc_by_nc_nd
Usage restriction: openAccess
Self-archived version: publishedVersion

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