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ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (ARASENS)

Primary Purpose

Metastatic Hormone-sensitive Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BAY1841788 / darolutamide (ODM-201)
Standard ADT (androgen deprivation therapy)
Docetaxel
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Hormone-sensitive Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel

Placebo + standard ADT + Docetaxel

Arm Description

Co-administration of BAY 1841788 / darolutamide (ODM-201), standard ADT and docetaxel

Co-administration of Placebo matching BAY 1841788 / darolutamide (ODM-201) tablets, standard ADT and docetaxel

Outcomes

Primary Outcome Measures

OS From Date of Randomization Until Death From Any Cause - Number of Events
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.
OS From Date of Randomization Until Death From Any Cause - Months
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

Secondary Outcome Measures

Number of Participants With TEAEs
TEAEs = Treatment-emergent adverse events Treatment-emergent AEs (TEAEs) were defined as any event(s) arising or worsening after the first dose of darolutamide or placebo, until 30 days after the last dose of darolutamide or placebo administration.
Time to Castration-Resistant Prostate Cancer (CRPC) - Number of Events
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
Time to Castration-Resistant Prostate Cancer (CRPC) - Month
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
Time to Pain Progression - Number of Events
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.
Time to Pain Progression - Month
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
Symptomatic Skeletal Event Free Survival (SSE-FS) - Number of Events
Symptomatic skeletal event-free survival (SSE-FS) was defined as the time from randomization to the first occurrence of an SSE or death from any cause, whichever occurred first. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. NA = Value cannot be estimated due to censored data
Symptomatic Skeletal Event Free Survival (SSE-FS) - Month
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
Time to First Symptomatic Skeletal Event (SSE) - Number of Events
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.
Time to First Symptomatic Skeletal Event (SSE) - Month
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
Time to Initiation of Subsequent Antineoplastic Therapy - Number of Events
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
Time to Initiation of Subsequent Antineoplastic Therapy - Month
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
Time to Worsening of Disease-Related Physical Symptoms - Number of Events
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.
Time to Worsening of Disease-Related Physical Symptoms - Month
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.
Time to Initiation of Opioid Use for ≥7 Consecutive Days - Number of Events
Time to the initiation of opioid use for ≥7 consecutive days was defined as the time fromrandomization to the date of the first opioid use for ≥7 consecutive days. Data of opioid use related to cancer pain was included in the analysis, and opioid use for non-malignant causes was excluded. Treatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.
Time to Initiation of Opioid Use for ≥7 Consecutive Days - Month
Time to the initiation of opioid use for ≥7 consecutive days was defined as the time fromrandomization to the date of the first opioid use for ≥7 consecutive days. Data of opioid use related to cancer pain was included in the analysis, and opioid use for non-malignant causes was excluded. Treatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. NA = Value cannot be estimated due to censored data

Full Information

First Posted
June 6, 2016
Last Updated
May 8, 2023
Sponsor
Bayer
Collaborators
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02799602
Brief Title
ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer
Acronym
ARASENS
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2016 (Actual)
Primary Completion Date
October 25, 2021 (Actual)
Study Completion Date
April 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Orion Corporation, Orion Pharma

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is a randomized, double-blind, placebo-controlled, multicenter phase III study. The study population will consist of approximately 1300 subjects with metastatic hormone sensitive prostate cancer (mHSPC), who will be randomized (1:1 ratio) to receive 600 mg (2 x 300 mg tablets) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a total daily dose of 1200 mg, in addition to standard androgen deprivation therapy (ADT) and docetaxel. Subjects will be stratified at randomization for the extent of disease and for Alkaline Phosphatase levels. All subjects will be treated with ADT as standard therapy. Six cycles of docetaxel will be administered after randomization. The subjects considered for inclusion in the study will have metastatic prostate cancer and will be candidates for ADT and docetaxel. Treatment with darolutamide (ODM-201)/placebo will be administered until symptomatic progressive disease, change of antineoplastic therapy, unacceptable toxicity, until subject withdraws consent, withdrawal from the study at the discretion of the investigator or his/her designated associate(s), death, non-compliance, or if sponsor terminates the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Hormone-sensitive Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel
Arm Type
Experimental
Arm Description
Co-administration of BAY 1841788 / darolutamide (ODM-201), standard ADT and docetaxel
Arm Title
Placebo + standard ADT + Docetaxel
Arm Type
Placebo Comparator
Arm Description
Co-administration of Placebo matching BAY 1841788 / darolutamide (ODM-201) tablets, standard ADT and docetaxel
Intervention Type
Drug
Intervention Name(s)
BAY1841788 / darolutamide (ODM-201)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Standard ADT (androgen deprivation therapy)
Intervention Description
As prescribed by the treating physician.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
As prescribed by the treating physician.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
OS From Date of Randomization Until Death From Any Cause - Number of Events
Description
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.
Time Frame
From randomization of the first subject until death from any cause up to the time 533 OS events were reached (approximately 59 months)
Title
OS From Date of Randomization Until Death From Any Cause - Months
Description
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
Time Frame
From randomization of the first subject until death from any cause up to the time 533 OS events were reached (approximately 59 months)
Secondary Outcome Measure Information:
Title
Number of Participants With TEAEs
Description
TEAEs = Treatment-emergent adverse events Treatment-emergent AEs (TEAEs) were defined as any event(s) arising or worsening after the first dose of darolutamide or placebo, until 30 days after the last dose of darolutamide or placebo administration.
Time Frame
From the first dose of darolutamide or placebo until cut-off date for the final analysis planned as 30 JUN 2023 (approximately 79 months)
Title
Time to Castration-Resistant Prostate Cancer (CRPC) - Number of Events
Description
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
Time Frame
From randomization of the first subject to the first occurrence of an CRPC event up to approximately 59 months
Title
Time to Castration-Resistant Prostate Cancer (CRPC) - Month
Description
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
Time Frame
From randomization of the first subject to the first occurrence of an CRPC event up to approximately 59 months
Title
Time to Pain Progression - Number of Events
Description
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.
Time Frame
From randomization of the first subject to the first occurrence of an pain progression event up to approximately 59 months
Title
Time to Pain Progression - Month
Description
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
Time Frame
From randomization of the first subject to the first occurrence of an pain progression event up to approximately 59 months
Title
Symptomatic Skeletal Event Free Survival (SSE-FS) - Number of Events
Description
Symptomatic skeletal event-free survival (SSE-FS) was defined as the time from randomization to the first occurrence of an SSE or death from any cause, whichever occurred first. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. NA = Value cannot be estimated due to censored data
Time Frame
From randomization of the first subject to the first occurrence of an SSE event or death from any cause, whichever occurred first up to approximately 59 months
Title
Symptomatic Skeletal Event Free Survival (SSE-FS) - Month
Description
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
Time Frame
From randomization of the first subject to the first occurrence of an SSE event or death from any cause, whichever occurred first up to approximately 59 months
Title
Time to First Symptomatic Skeletal Event (SSE) - Number of Events
Description
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.
Time Frame
From randomization of the first subject to the first occurrence of an SSE event up to approximately 59 months
Title
Time to First Symptomatic Skeletal Event (SSE) - Month
Description
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
Time Frame
From randomization of the first subject to the first occurrence of an SSE event up to approximately 59 months
Title
Time to Initiation of Subsequent Antineoplastic Therapy - Number of Events
Description
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
Time Frame
From randomization of the first subject to the initiation of first subsequent systemic antineoplastic therapy up to approximately 59 months
Title
Time to Initiation of Subsequent Antineoplastic Therapy - Month
Description
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
Time Frame
From randomization of the first subject to the initiation of first subsequent systemic antineoplastic therapy up to approximately 59 months
Title
Time to Worsening of Disease-Related Physical Symptoms - Number of Events
Description
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.
Time Frame
From randomization of the first subject to the first increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire up to approximately 59 months
Title
Time to Worsening of Disease-Related Physical Symptoms - Month
Description
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.
Time Frame
From randomization of the first subject to the first increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire up to approximately 59 months
Title
Time to Initiation of Opioid Use for ≥7 Consecutive Days - Number of Events
Description
Time to the initiation of opioid use for ≥7 consecutive days was defined as the time fromrandomization to the date of the first opioid use for ≥7 consecutive days. Data of opioid use related to cancer pain was included in the analysis, and opioid use for non-malignant causes was excluded. Treatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.
Time Frame
From randomization of the first subject to the first opioid use for ≥7 consecutive days up to approximately 59 months
Title
Time to Initiation of Opioid Use for ≥7 Consecutive Days - Month
Description
Time to the initiation of opioid use for ≥7 consecutive days was defined as the time fromrandomization to the date of the first opioid use for ≥7 consecutive days. Data of opioid use related to cancer pain was included in the analysis, and opioid use for non-malignant causes was excluded. Treatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. NA = Value cannot be estimated due to censored data
Time Frame
From randomization of the first subject to the first opioid use for ≥7 consecutive days up to approximately 59 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211-1850
Country
United States
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073-1003
Country
United States
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5820
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007-2113
Country
United States
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0316
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615-7828
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2696
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130-5606
Country
United States
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-1000
Country
United States
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08143
Country
United States
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07361
Country
United States
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2490
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-2416
Country
United States
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409-1328
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5799
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-5054
Country
United States
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
City
Wilrijk
State/Province
Antwerpen
ZIP/Postal Code
2610
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1000
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1070
Country
Belgium
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Namur
ZIP/Postal Code
5000
Country
Belgium
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41253-190
Country
Brazil
City
Cachoeiro de Itapemirim
State/Province
Espírito Santo
ZIP/Postal Code
29308-020
Country
Brazil
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520-060
Country
Brazil
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59040-000
Country
Brazil
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050 170
Country
Brazil
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09060-650
Country
Brazil
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04014-002
Country
Brazil
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
City
Pleven
ZIP/Postal Code
5809
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
City
Shengyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
City
Beijing
ZIP/Postal Code
100034
Country
China
City
Beijing
ZIP/Postal Code
100050
Country
China
City
Beijing
ZIP/Postal Code
100083
Country
China
City
Beijing
ZIP/Postal Code
100142
Country
China
City
Beijing
ZIP/Postal Code
100730
Country
China
City
Chongqing
ZIP/Postal Code
400030
Country
China
City
Shanghai
ZIP/Postal Code
200032
Country
China
City
Shanghai
ZIP/Postal Code
200040
Country
China
City
Shanghai
ZIP/Postal Code
200072
Country
China
City
Shanghai
ZIP/Postal Code
200080
Country
China
City
Shanghai
ZIP/Postal Code
200092
Country
China
City
Tianjin
ZIP/Postal Code
300052
Country
China
City
Tianjin
ZIP/Postal Code
300060
Country
China
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
City
Mikkeli
ZIP/Postal Code
FIN-50100
Country
Finland
City
Oulu
ZIP/Postal Code
90220
Country
Finland
City
Tampere
ZIP/Postal Code
33521
Country
Finland
City
Turku
ZIP/Postal Code
20520
Country
Finland
City
Angers Cedex
ZIP/Postal Code
49055
Country
France
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
City
Brest
ZIP/Postal Code
29200
Country
France
City
Cergy Pontoise
ZIP/Postal Code
95303
Country
France
City
Clermont-ferrand
ZIP/Postal Code
63011
Country
France
City
Creteil
ZIP/Postal Code
94010
Country
France
City
Marseille
ZIP/Postal Code
13273
Country
France
City
Montpellier Cedex
ZIP/Postal Code
34298
Country
France
City
Nancy
ZIP/Postal Code
54100
Country
France
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
City
Poitiers
ZIP/Postal Code
86021
Country
France
City
Reims
ZIP/Postal Code
51726
Country
France
City
Saint Herblain Cedex
ZIP/Postal Code
44805
Country
France
City
Saint-gregoire
ZIP/Postal Code
35760
Country
France
City
Strasbourg
ZIP/Postal Code
67033
Country
France
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
City
Nürtingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72622
Country
Germany
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89075
Country
Germany
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18107
Country
Germany
City
Braunschweig
State/Province
Niedersachsen
ZIP/Postal Code
38126
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07747
Country
Germany
City
Berlin
ZIP/Postal Code
12203
Country
Germany
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
City
Holon
ZIP/Postal Code
5822012
Country
Israel
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
City
Zefat
ZIP/Postal Code
1311001
Country
Israel
City
Zrifin
ZIP/Postal Code
7030000
Country
Israel
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43126
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
City
Novara
State/Province
Piemonte
ZIP/Postal Code
28100
Country
Italy
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
City
Trento
State/Province
Trentino-Alto Adige
ZIP/Postal Code
38100
Country
Italy
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
City
Verona
State/Province
Veneto
ZIP/Postal Code
37134
Country
Italy
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8563
Country
Japan
City
Asahi
State/Province
Chiba
ZIP/Postal Code
289-2511
Country
Japan
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
City
Sakura
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
City
Kita
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
City
Utsunomiya
State/Province
Tochigi
ZIP/Postal Code
321-0974
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
City
Nakano-ku
State/Province
Tokyo
ZIP/Postal Code
164-8541
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8543
Country
Japan
City
Yonago
State/Province
Tottori
ZIP/Postal Code
683-8504
Country
Japan
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
City
Gifu
ZIP/Postal Code
500-8717
Country
Japan
City
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
City
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
City
Gwangju
State/Province
Gwangju Gwang''yeogsi
ZIP/Postal Code
61469
Country
Korea, Republic of
City
Seongnam-si
State/Province
Gyeonggido
ZIP/Postal Code
13620
Country
Korea, Republic of
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03080
Country
Korea, Republic of
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06273
Country
Korea, Republic of
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
City
Gyeonggi-do
ZIP/Postal Code
11923
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
City
Ciudad de Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06760
Country
Mexico
City
México, D. F.
State/Province
Distrito Federal
ZIP/Postal Code
06760
Country
Mexico
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
City
Santiago de Querétaro
State/Province
Querétaro
ZIP/Postal Code
76000
Country
Mexico
City
Mazatlán
State/Province
Sinaloa
ZIP/Postal Code
82110
Country
Mexico
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
City
Den Haag
ZIP/Postal Code
2545 AA
Country
Netherlands
City
Dordrecht
ZIP/Postal Code
3318 AT
Country
Netherlands
City
Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
City
Hilversum
ZIP/Postal Code
1213 XZ
Country
Netherlands
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
City
Tilburg
ZIP/Postal Code
5042 AD
Country
Netherlands
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
City
Waliszew
ZIP/Postal Code
05-135
Country
Poland
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
188663
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
194017
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
197136
Country
Russian Federation
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
City
Palma De Mallorca
State/Province
Illes Baleares
ZIP/Postal Code
7120
Country
Spain
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
City
Lugo
ZIP/Postal Code
27003
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Málaga
ZIP/Postal Code
29010
Country
Spain
City
Valencia
ZIP/Postal Code
46009
Country
Spain
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
City
Solna
ZIP/Postal Code
171 64
Country
Sweden
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
City
Colchester
State/Province
Essex
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
City
Romford
State/Province
Essex
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
City
Middlesborough
State/Province
North Yorkshire
ZIP/Postal Code
TS43BW
Country
United Kingdom
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Citations:
PubMed Identifier
35656777
Citation
Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford D, Manarite J, Muslin D, Farrington T, Tombal B. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer: a patient and caregiver perspective and plain language summary of the ARASENS trial. Future Oncol. 2022 Jul;18(21):2585-2597. doi: 10.2217/fon-2022-0433. Epub 2022 Jun 3.
Results Reference
derived
PubMed Identifier
35179323
Citation
Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, Kopyltsov E, Park CH, Alekseev B, Montesa-Pino A, Ye D, Parnis F, Cruz F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Mendez-Vidal MJ, Maughan BL, Joensuu H, Thiele S, Li R, Kuss I, Tombal B; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142. doi: 10.1056/NEJMoa2119115. Epub 2022 Feb 17.
Results Reference
derived
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Learn more about this trial

ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer

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