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← Xtandi: metastatic Prostate Cancer

NCT02200614 · STUDY IN CONTEXT

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant 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

Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first (cut-off date 15 Nov 2019)

Source null

→

secondary · POSTED

Overall Survival (OS) was defined as the time from randomization to death due to any cause.

Source null

→

secondary · POSTED

Time to pain progression (PP) is defined as time from randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline in question 3 of the Brief Pain Inventory-Short Form questionnaire (BPI-SF) related to the worst pain in the last 24 hours taken as a 7-day average for post-baseline scores, or initiation of short or long-acting opioids for pain, whichever comes first. Initiation or change in the use of other non-opioid analgesics is not used in the analysis of pain progression.

Source null

→

secondary · POSTED

The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle.

Source null

→

secondary · POSTED

The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE.

Source null

→

secondary · POSTED

Overall Survival (OS) was defined as the time from randomization to death due to any cause. The final analysis was done at the time of the data cut-off (15 NOV 2019).

Source null

→

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

Brief Pain Inventory · Time to Pain Progression - Primary Analysis

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-xtandi-532fb7f0
nct id
NCT02200614
qol key
qol-0002
source section id
NCT02200614-om-0002
source outcome index
2
instrument
Brief Pain Inventory
instrument basis
matched 'brief pain inventory' in the study's own wording
scale title
Time to Pain Progression - Primary Analysis
measure definition
Time to pain progression (PP) is defined as time from randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline in question 3 of the Brief Pain Inventory-Short Form questionnaire (BPI-SF) related to the worst pain in the last 24 hours taken as a 7-day average for post-baseline scores, or initiation of short or long-acting opioids for pain, whichever comes first. Initiation or change in the use of other non-opioid analgesics is not used in the analysis of pain progression.
time frame
From randomization until last study treatment (assessed every 4 months) (approximately 48 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-xtandi-532fb7f0
nct id
NCT02200614
trial label
Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant 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
4
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0000
    source section id
    NCT02200614-om-0000
    source outcome index
    0
    endpoint
    Metastasis-Free Survival
    endpoint definition
    Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first (cut-off date 15 Nov 2019)
    time origin
    From randomization to the time approximately 385 MFS events were observed (approximately 48 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-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0001
    source section id
    NCT02200614-om-0001
    source outcome index
    1
    endpoint
    Overall Survival - Primary Analysis
    endpoint definition
    Overall Survival (OS) was defined as the time from randomization to death due to any cause.
    time origin
    From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0002
    source section id
    NCT02200614-om-0002
    source outcome index
    2
    endpoint
    Time to Pain Progression - Primary Analysis
    endpoint definition
    Time to pain progression (PP) is defined as time from randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline in question 3 of the Brief Pain Inventory-Short Form questionnaire (BPI-SF) related to the worst pain in the last 24 hours taken as a 7-day average for post-baseline scores, or initiation of short or long-acting opioids for pain, whichever comes first. Initiation or change in the use of other non-opioid analgesics is not used in the analysis of pain progression.
    time origin
    From randomization until last study treatment (assessed every 4 months) (approximately 48 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-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0003
    source section id
    NCT02200614-om-0003
    source outcome index
    3
    endpoint
    Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer - Primary Analysis
    endpoint definition
    The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle.
    time origin
    From randomization until last study treatment (assessed every 4 months) (approximately 48 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-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0004
    source section id
    NCT02200614-om-0004
    source outcome index
    4
    endpoint
    Time to First Symptomatic Skeletal Event (SSE) - Primary Analysis
    endpoint definition
    The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE.
    time origin
    From randomization until last study treatment (assessed every 4 months) (approximately 48 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-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0005
    source section id
    NCT02200614-om-0005
    source outcome index
    5
    endpoint
    Overall Survival - Final Analysis
    endpoint definition
    Overall Survival (OS) was defined as the time from randomization to death due to any cause. The final analysis was done at the time of the data cut-off (15 NOV 2019).
    time origin
    From randomization of the first subject to the time approximatively 254 death events were observed (approximately 56 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-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Darolutamide (BAY1841788)
    regimen
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
    analyzed count
    955
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02200614-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo
    regimen
    Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
    analyzed count
    554
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02200614-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Darolutamide (BAY1841788)
    regimen
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
    analyzed count
    955
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02200614-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo
    regimen
    Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
    analyzed count
    554
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02200614-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Darolutamide (BAY1841788)
    regimen
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
    analyzed count
    955
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02200614-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo
    regimen
    Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
    analyzed count
    554
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02200614-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Darolutamide (BAY1841788)
    regimen
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
    analyzed count
    955
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02200614-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo
    regimen
    Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
    analyzed count
    554
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02200614-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Darolutamide (BAY1841788)
    regimen
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
    analyzed count
    955
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02200614-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo
    regimen
    Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
    analyzed count
    554
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02200614-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Darolutamide (BAY1841788)
    regimen
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
    analyzed count
    955
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02200614-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02200614
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo
    regimen
    Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
    analyzed count
    554
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02200614-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer-xtandi-532fb7f0
    nct id
    NCT02200614
    harm key
    EG000
    source section id
    NCT02200614-ae
    event group key
    EG000
    event group label
    Darolutamide (DB)
    serious affected
    251
    serious at risk
    954
    other affected
    673
    other at risk
    954
    frequency threshold
    2
    collection period
    From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
    event definition
    Source null
    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-xtandi-532fb7f0
    nct id
    NCT02200614
    harm key
    EG001
    source section id
    NCT02200614-ae
    event group key
    EG001
    event group label
    Darolutamide (DB+OL)
    serious affected
    367
    serious at risk
    954
    other affected
    742
    other at risk
    954
    frequency threshold
    2
    collection period
    From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
    event definition
    Source null
    undenominated note
    Source null
    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-xtandi-532fb7f0
    nct id
    NCT02200614
    harm key
    EG002
    source section id
    NCT02200614-ae
    event group key
    EG002
    event group label
    Placebo (DB)
    serious affected
    121
    serious at risk
    554
    other affected
    354
    other at risk
    554
    frequency threshold
    2
    collection period
    From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
    event definition
    Source null
    undenominated 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-xtandi-532fb7f0
    nct id
    NCT02200614
    harm key
    EG003
    source section id
    NCT02200614-ae
    event group key
    EG003
    event group label
    Placebo+Darolutamide (CO)
    serious affected
    43
    serious at risk
    170
    other affected
    110
    other at risk
    170
    frequency threshold
    2
    collection period
    From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
    event definition
    Source null
    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-xtandi-532fb7f0
    nct id
    NCT02200614
    qol key
    qol-0002
    source section id
    NCT02200614-om-0002
    source outcome index
    2
    instrument
    Brief Pain Inventory
    instrument basis
    matched 'brief pain inventory' in the study's own wording
    scale title
    Time to Pain Progression - Primary Analysis
    measure definition
    Time to pain progression (PP) is defined as time from randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline in question 3 of the Brief Pain Inventory-Short Form questionnaire (BPI-SF) related to the worst pain in the last 24 hours taken as a 7-day average for post-baseline scores, or initiation of short or long-acting opioids for pain, whichever comes first. Initiation or change in the use of other non-opioid analgesics is not used in the analysis of pain progression.
    time frame
    From randomization until last study treatment (assessed every 4 months) (approximately 48 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