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← Jevtana: metastatic Prostate Cancer

NCT02799602 · STUDY IN CONTEXT

Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Source null

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secondary · POSTED

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.

The number of patients who started treatment is presented based on the randomized treatment assignment. One patient was randomized to the placebo+docetaxel arm but received at least one dose of darolutamide. This patient was included in the darolutamide+docetaxel arm in the analysis of all safety variables.

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secondary · POSTED

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.

Source null

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secondary · POSTED

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

Source null

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secondary · POSTED

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.

Source null

→

secondary · POSTED

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

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Time to Worsening of Disease-Related Physical Symptoms - Number of Events

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT02799602
qol key
qol-0012
source section id
NCT02799602-om-0012
source outcome index
12
instrument
FACT
instrument basis
matched 'fact-fpsi' in the study's own wording
scale title
Time to Worsening of Disease-Related Physical Symptoms - Number of Events
measure definition
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 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
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Time to Worsening of Disease-Related Physical Symptoms - Month

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT02799602
qol key
qol-0013
source section id
NCT02799602-om-0013
source outcome index
13
instrument
FACT
instrument basis
matched 'fact-fpsi' in the study's own wording
scale title
Time to Worsening of Disease-Related Physical Symptoms - Month
measure definition
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 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
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer-jevtana-f72c24a3
nct id
NCT02799602
trial label
Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0000
    source section id
    NCT02799602-om-0000
    source outcome index
    0
    endpoint
    OS From Date of Randomization Until Death From Any Cause - Number of Events
    endpoint definition
    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 origin
    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)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0001
    source section id
    NCT02799602-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With TEAEs
    endpoint definition
    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.
    time origin
    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)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The number of patients who started treatment is presented based on the randomized treatment assignment. One patient was randomized to the placebo+docetaxel arm but received at least one dose of darolutamide. This patient was included in the darolutamide+docetaxel arm in the analysis of all safety variables.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0002
    source section id
    NCT02799602-om-0002
    source outcome index
    2
    endpoint
    Time to Castration-Resistant Prostate Cancer (CRPC) - Number of Events
    endpoint definition
    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.
    time origin
    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
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0003
    source section id
    NCT02799602-om-0003
    source outcome index
    3
    endpoint
    Time to Castration-Resistant Prostate Cancer (CRPC) - Month
    endpoint definition
    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 origin
    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
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0004
    source section id
    NCT02799602-om-0004
    source outcome index
    4
    endpoint
    Time to Pain Progression - Number of Events
    endpoint definition
    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 origin
    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
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0005
    source section id
    NCT02799602-om-0005
    source outcome index
    5
    endpoint
    Time to Pain Progression - Month
    endpoint definition
    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 origin
    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
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Darolutamide (BAY1841788) + Docetaxel
    regimen
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    analyzed count
    651
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02799602-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo + Docetaxel
    regimen
    Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    analyzed count
    654
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02799602-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Darolutamide (BAY1841788) + Docetaxel
    regimen
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    analyzed count
    652
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02799602-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo + Docetaxel
    regimen
    Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    analyzed count
    650
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02799602-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Darolutamide (BAY1841788) + Docetaxel
    regimen
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    analyzed count
    651
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02799602-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo + Docetaxel
    regimen
    Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    analyzed count
    654
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02799602-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Darolutamide (BAY1841788) + Docetaxel
    regimen
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    analyzed count
    651
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02799602-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo + Docetaxel
    regimen
    Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    analyzed count
    654
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02799602-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Darolutamide (BAY1841788) + Docetaxel
    regimen
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    analyzed count
    651
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02799602-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo + Docetaxel
    regimen
    Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    analyzed count
    654
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02799602-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Darolutamide (BAY1841788) + Docetaxel
    regimen
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    analyzed count
    651
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02799602-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo + Docetaxel
    regimen
    Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.
    analyzed count
    654
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02799602-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    harm key
    EG000
    source section id
    NCT02799602-ae
    event group key
    EG000
    event group label
    Darolutamide (BAY1841788) + Docetaxel
    serious affected
    306
    serious at risk
    652
    other affected
    636
    other at risk
    652
    frequency threshold
    5
    collection period
    From start of study drug administration until 30 days after the last administration, including adverse event of all-cause mortality at any time during the study, up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months)
    event definition
    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. Events causally related to treatment were considered as events causally related to either darolutamide / Docetaxel or Placebo / Docetaxel A total of 1305 patients were randomized for efficacy analysis, however 1302 patients only started treatment and were included to safety analyses.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    harm key
    EG001
    source section id
    NCT02799602-ae
    event group key
    EG001
    event group label
    Placebo + Docetaxel
    serious affected
    276
    serious at risk
    650
    other affected
    634
    other at risk
    650
    frequency threshold
    5
    collection period
    From start of study drug administration until 30 days after the last administration, including adverse event of all-cause mortality at any time during the study, up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months)
    event definition
    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. Events causally related to treatment were considered as events causally related to either darolutamide / Docetaxel or Placebo / Docetaxel A total of 1305 patients were randomized for efficacy analysis, however 1302 patients only started treatment and were included to safety analyses.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    qol key
    qol-0012
    source section id
    NCT02799602-om-0012
    source outcome index
    12
    instrument
    FACT
    instrument basis
    matched 'fact-fpsi' in the study's own wording
    scale title
    Time to Worsening of Disease-Related Physical Symptoms - Number of Events
    measure definition
    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 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
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-jevtana-f72c24a3
    nct id
    NCT02799602
    qol key
    qol-0013
    source section id
    NCT02799602-om-0013
    source outcome index
    13
    instrument
    FACT
    instrument basis
    matched 'fact-fpsi' in the study's own wording
    scale title
    Time to Worsening of Disease-Related Physical Symptoms - Month
    measure definition
    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 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
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice