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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02799602
Registration number
NCT02799602
Ethics application status
Date submitted
6/06/2016
Date registered
15/06/2016
Date last updated
16/04/2024
Titles & IDs
Public title
Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
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Scientific title
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
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Secondary ID [1]
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2015-002590-38
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Secondary ID [2]
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17777
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Universal Trial Number (UTN)
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Trial acronym
ARASENS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Hormone-sensitive Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Inflammatory and Immune System
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BAY1841788 / darolutamide (ODM-201)
Treatment: Drugs - Standard ADT (androgen deprivation therapy)
Treatment: Drugs - Docetaxel
Treatment: Drugs - Placebo
Experimental: BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel - Co-administration of BAY 1841788 / darolutamide (ODM-201), standard ADT and docetaxel
Placebo Comparator: Placebo + standard ADT + Docetaxel - Co-administration of Placebo matching BAY 1841788 / darolutamide (ODM-201) tablets, standard ADT and docetaxel
Treatment: Drugs: BAY1841788 / darolutamide (ODM-201)
600mg (2 tablets of 300 mg) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a total a daily dose of 1200 mg in addition to standard ADT (luteinizing hormone releasing hormone (LHRH) agonist/antagonist or orchiectomy) and 6 cycles of docetaxel
Treatment: Drugs: Standard ADT (androgen deprivation therapy)
As prescribed by the treating physician.
Treatment: Drugs: Docetaxel
As prescribed by the treating physician.
Treatment: Drugs: Placebo
Placebo matching darolutamide (ODM-201) tablets in appearance, bid orally with food, in addition to standard ADT (luteinizing hormone releasing hormone [LHRH] agonist/antagonist or orchiectomy) and 6 cycles of docetaxel.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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OS From Date of Randomization Until Death From Any Cause - Number of Events
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Assessment method [1]
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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.
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Timepoint [1]
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From randomization of the first participant until death from any cause up to 25 OCT 2021 cut-off date 533 OS events were reached (approximate 59 months)
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Primary outcome [2]
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OS From Date of Randomization Until Death From Any Cause - Month
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Assessment method [2]
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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.
Median, percentile and other 95% CIs were computed using Kaplan-Meier estimates.
NA = Value cannot be estimated due to censored data
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Timepoint [2]
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From randomization of the first participant until death from any cause up to 25 OCT 2021 cut-off date 533 OS events were reached (approximate 59 months)
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Secondary outcome [1]
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Number of Participants With TEAEs
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Assessment method [1]
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TEAEs = Treatment-emergent adverse events, 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.
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Timepoint [1]
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From the first dose of darolutamide or placebo until 30 days after the last dose of darolutamide or placebo administration up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months)
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Secondary outcome [2]
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Time to Castration-Resistant Prostate Cancer (CRPC) - Number of Events
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Assessment method [2]
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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.
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Timepoint [2]
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From randomization of the first participant to the first occurrence of an CRPC event up to 25 OCT 2021 cut-off date approximately 59 months
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Secondary outcome [3]
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Time to Castration-Resistant Prostate Cancer (CRPC) - Month
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Assessment method [3]
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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
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Timepoint [3]
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From randomization of the first participant to the first occurrence of an CRPC event up to 25 OCT 2021 cut-off date approximately 59 months
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Secondary outcome [4]
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Time to Pain Progression - Number of Events
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Assessment method [4]
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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.
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Timepoint [4]
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From randomization of the first participant to the first occurrence of a pain progression event up to 25 OCT 2021 cut-off date approximately 59 months
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Secondary outcome [5]
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Time to Pain Progression - Month
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Assessment method [5]
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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.
NA = Value cannot be estimated due to censored data
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Timepoint [5]
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From randomization of the first participant to the first occurrence of a pain progression event up to 25 OCT 2021 cut-off date approximately 59 months
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Secondary outcome [6]
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Symptomatic Skeletal Event Free Survival (SSE-FS) - Number of Events
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Assessment method [6]
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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.
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Timepoint [6]
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From randomization of the first participant to the first occurrence of an SSE event or death from any cause, whichever occurred first up to 25 OCT 2021 cut-off date approximately 59 months
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Secondary outcome [7]
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Symptomatic Skeletal Event Free Survival (SSE-FS) - Month
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Assessment method [7]
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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: 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
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Timepoint [7]
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From randomization of the first participant to the first occurrence of an SSE event or death from any cause, whichever occurred first up to 25 OCT 2021 cut-off date approximately 59 months
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Secondary outcome [8]
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Time to First Symptomatic Skeletal Event (SSE) - Number of Events
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Assessment method [8]
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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.
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Timepoint [8]
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From randomization of the first participant to the first occurrence of an SSE event up to 25 OCT 2021 cut-off date approximately 59 months
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Secondary outcome [9]
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Time to First Symptomatic Skeletal Event (SSE) - Month
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Assessment method [9]
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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.
NA = Value cannot be estimated due to censored data
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Timepoint [9]
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From randomization of the first participant to the first occurrence of an SSE event up to 25 OCT 2021 cut-off date approximately 59 months
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Secondary outcome [10]
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Time to Initiation of Subsequent Antineoplastic Therapy - Number of Events
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Assessment method [10]
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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.
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Timepoint [10]
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From randomization of the first participant to the initiation of first subsequent systemic antineoplastic therapy up to 25 OCT 2021 cut-off date approximately 59 months
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Secondary outcome [11]
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Time to Initiation of Subsequent Antineoplastic Therapy - Month
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Assessment method [11]
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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
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Timepoint [11]
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From randomization of the first participant to the initiation of first subsequent systemic antineoplastic therapy up to 25 OCT 2021 cut-off date approximately 59 months
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Secondary outcome [12]
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Time to Worsening of Disease-Related Physical Symptoms - Number of Events
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Assessment method [12]
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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.
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Timepoint [12]
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From randomization of the first participant to the first increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire up to 25 OCT 2021 cut-off date approximately 59 months
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Secondary outcome [13]
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Time to Worsening of Disease-Related Physical Symptoms - Month
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Assessment method [13]
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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.
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Timepoint [13]
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From randomization of the first participant to the first increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire up to 25 OCT 2021 cut-off date approximately 59 months
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Secondary outcome [14]
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Time to Initiation of Opioid Use for =7 Consecutive Days - Number of Events
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Assessment method [14]
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Time to the initiation of opioid use for =7 consecutive days was defined as the time from randomization 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.
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Timepoint [14]
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From randomization of the first participant to the first opioid use for =7 consecutive days up to 25 OCT 2021 cut-off date approximately 59 months
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Secondary outcome [15]
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Time to Initiation of Opioid Use for =7 Consecutive Days - Month
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Assessment method [15]
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Time to the initiation of opioid use for =7 consecutive days was defined as the time from randomization 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.
NA = Value cannot be estimated due to censored data
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Timepoint [15]
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From randomization of the first participant to the first opioid use for =7 consecutive days up to 25 OCT 2021 cut-off date approximately 59 months
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Eligibility
Key inclusion criteria
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/11/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/04/2023
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Sample size
Target
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Accrual to date
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Final
1306
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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- Randwick
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Recruitment hospital [2]
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- Sydney
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Recruitment hospital [3]
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- Adelaide
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Recruitment hospital [4]
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- Kurralta Park
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Recruitment hospital [5]
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- Fitzroy
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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2010 - Sydney
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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5037 - Kurralta Park
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Recruitment postcode(s) [5]
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3065 - Fitzroy
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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0
0
United States of America
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State/province [2]
0
0
California
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0
0
United States of America
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State/province [3]
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0
District of Columbia
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0
0
United States of America
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State/province [4]
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0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
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0
Georgia
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Country [6]
0
0
United States of America
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State/province [6]
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0
Illinois
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Country [7]
0
0
United States of America
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State/province [7]
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0
Kentucky
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Louisiana
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Maryland
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Country [10]
0
0
United States of America
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State/province [10]
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0
Massachusetts
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Country [11]
0
0
United States of America
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State/province [11]
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Michigan
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Montana
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Nebraska
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Country [14]
0
0
United States of America
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State/province [14]
0
0
New Hampshire
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Country [15]
0
0
United States of America
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State/province [15]
0
0
New Jersey
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Country [16]
0
0
United States of America
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State/province [16]
0
0
New Mexico
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Country [17]
0
0
United States of America
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State/province [17]
0
0
New York
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Country [18]
0
0
United States of America
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State/province [18]
0
0
North Carolina
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Ohio
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Oklahoma
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Country [21]
0
0
United States of America
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State/province [21]
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Pennsylvania
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0
0
United States of America
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State/province [22]
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South Carolina
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0
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United States of America
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State/province [23]
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Texas
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0
0
United States of America
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State/province [24]
0
0
Utah
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0
0
United States of America
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State/province [25]
0
0
Virginia
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0
0
United States of America
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State/province [26]
0
0
Washington
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0
0
United States of America
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State/province [27]
0
0
Wisconsin
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0
0
Belgium
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State/province [28]
0
0
Antwerpen
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Country [29]
0
0
Belgium
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State/province [29]
0
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Brussels
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Country [30]
0
0
Belgium
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State/province [30]
0
0
Bruxelles - Brussel
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Country [31]
0
0
Belgium
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State/province [31]
0
0
Charleroi
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Country [32]
0
0
Belgium
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State/province [32]
0
0
Gent
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Country [33]
0
0
Belgium
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State/province [33]
0
0
Namur
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Country [34]
0
0
Brazil
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State/province [34]
0
0
Bahia
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0
0
Brazil
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State/province [35]
0
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Espírito Santo
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Country [36]
0
0
Brazil
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State/province [36]
0
0
Parana
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Country [37]
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Brazil
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Rio Grande Do Norte
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Brazil
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Brazil
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Sao Paulo
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Brazil
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Rio de Janeiro
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Bulgaria
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Gabrovo
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Bulgaria
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Vratsa
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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China
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Anhui
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Country [50]
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China
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Fujian
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China
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Guangdong
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China
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Hebei
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China
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Henan
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Jiangxi
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China
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Jilin
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China
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Liaoning
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China
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Shaanxi
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China
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Shandong
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China
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Zhejiang
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China
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Beijing
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China
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Chongqing
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China
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Shanghai
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China
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Tianjin
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Country [67]
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Czechia
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Brno
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Country [68]
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Czechia
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Praha 10
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Czechia
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Praha 2
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Czechia
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Praha 5
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Czechia
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Praha 8
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Finland
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Helsinki
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Finland
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Jyväskylä
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Finland
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Kuopio
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Finland
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Mikkeli
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Finland
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Oulu
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Finland
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Tampere
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Finland
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Turku
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Angers Cedex
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France
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Besancon
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France
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France
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Brest
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France
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Cergy Pontoise
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France
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France
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Creteil
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France
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Marseille
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France
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Montpellier Cedex
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France
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Nancy
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France
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Pierre Benite
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France
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Poitiers
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France
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Reims
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France
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Saint Herblain Cedex
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France
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Saint-gregoire
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France
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Strasbourg
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France
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Villejuif Cedex
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Germany
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Baden-Württemberg
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Germany
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Bayern
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Germany
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Mecklenburg-Vorpommern
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Germany
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Niedersachsen
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Germany
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Germany
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Sachsen-Anhalt
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Germany
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Thüringen
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Germany
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Berlin
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Holon
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Israel
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Jerusalem
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0
Israel
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Petach Tikva
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Israel
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Tel Aviv
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Country [110]
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0
Israel
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Zefat
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Country [111]
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Israel
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Zrifin
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Italy
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Emilia-Romagna
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Italy
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Lazio
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0
Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Trentino-Alto Adige
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Italy
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Veneto
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Japan
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Aichi
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Japan
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Aomori
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Kagawa
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Japan
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Kanagawa
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Japan
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Mie
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Country [128]
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Japan
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Miyagi
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Country [129]
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Japan
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Nara
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Japan
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Osaka
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Japan
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Shizuoka
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Japan
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Tochigi
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Japan
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Tokyo
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Japan
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Tottori
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Japan
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Yamaguchi
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Japan
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Fukuoka
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Japan
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Gifu
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Japan
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Kumamoto
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Japan
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Miyazaki
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Japan
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Nagasaki
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0
Japan
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Okayama
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Japan
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Tokushima
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Japan
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Wakayama
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Korea, Republic of
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Gwangju Gwang''yeogsi
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Mexico
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Morelos
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Mexico
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Nuevo Leon
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Mexico
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Querétaro
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Mexico
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Sinaloa
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Netherlands
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Amsterdam
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Netherlands
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Den Haag
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Netherlands
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Dordrecht
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Netherlands
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Geleen
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Netherlands
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Hilversum
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Netherlands
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Hoofddorp
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Netherlands
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Tilburg
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Country [163]
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Rybnik
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Country [166]
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Poland
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State/province [166]
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Siedlce
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Poland
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Waliszew
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Poland
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Warszawa
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Country [169]
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0
Russian Federation
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Barnaul
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Country [170]
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Russian Federation
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Chelyabinsk
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Country [171]
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Russian Federation
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Moscow
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Country [172]
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0
Russian Federation
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Novosibirsk
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0
Russian Federation
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Omsk
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Country [174]
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0
Russian Federation
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St. Petersburg
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Country [175]
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0
Spain
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Barcelona
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Spain
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Illes Baleares
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Country [177]
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Spain
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Málaga
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Country [178]
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Spain
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Cáceres
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Spain
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Córdoba
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Spain
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Lugo
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Country [181]
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Spain
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0
Madrid
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Country [182]
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0
Spain
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Valencia
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Country [183]
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0
Sweden
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0
Göteborg
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Country [184]
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0
Sweden
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Lund
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0
Sweden
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Stockholm
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Country [186]
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Sweden
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Umea
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Sweden
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Uppsala
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Country [190]
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Taiwan
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Taipei
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Country [191]
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0
Taiwan
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State/province [191]
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Taoyuan
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Country [192]
0
0
United Kingdom
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Essex
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Country [193]
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0
United Kingdom
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North Yorkshire
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Country [194]
0
0
United Kingdom
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Belfast
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Country [195]
0
0
United Kingdom
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0
Glasgow
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Country [196]
0
0
United Kingdom
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State/province [196]
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0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bayer
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Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Orion Corporation, Orion Pharma
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Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02799602
Query!
Trial related presentations / publications
Query!
Public notes
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Contacts
Principal investigator
Name
0
0
Bayer Study Director
Query!
Address
0
0
Bayer
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
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Country
0
0
Query!
Phone
0
0
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Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02799602
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