Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02003924 · FLOW

Participant flow

Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer · Source last updated 2026-01-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
    id
    FG000
    title
    Enzalutamide 160 mg
  2. description
    Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    id
    FG001
    title
    Placebo
  3. description
    Participants who received placebo in double-blind phase and who agreed to proceed to open-label phase, received 4 capsules of Enzalutamide 40 mg each (total dose of 160 mg per day), orally once daily (up to a maximum of 18.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    id
    FG002
    title
    Placebo Participants Crossover to Enzalutamide 160 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    3. reasons
      1. group Id
        FG000
        num Subjects
        71
      2. group Id
        FG001
        num Subjects
        47
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal Consent to Continue Treatment
    4. reasons
      1. group Id
        FG000
        num Subjects
        229
      2. group Id
        FG001
        num Subjects
        247
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        120
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Randomized But not Treated
    7. reasons
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        50
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        933
      2. group Id
        FG001
        num Subjects
        468
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        930
      2. group Id
        FG001
        num Subjects
        465
      3. group Id
        FG002
        num Subjects
        0
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        478
      2. group Id
        FG001
        num Subjects
        87
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        455
      2. group Id
        FG001
        num Subjects
        381
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Double-blind Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal Consent to Continue Treatment
    3. reasons
      1. group Id
        FG000
        num Subjects
        59
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Disease Progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        10
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        478
      2. comment
        Participants were offered to switch from double blind placebo to open label Enzalutamide.
        group Id
        FG001
        num Subjects
        0
      3. comment
        Participants previously treated with placebo, switched to receive open label Enzalutamide.
        group Id
        FG002
        num Subjects
        87
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        478
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        87
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        378
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        70
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        17
      type
      NOT COMPLETED
    title
    Open-label Phase
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        288
      2. group Id
        FG001
        num Subjects
        174
      3. group Id
        FG002
        num Subjects
        4
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        55
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrew Consent to Be Followed
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. comment
        Participants followed up after discontinuing study drug in either double blind or open label phase.
        group Id
        FG000
        num Subjects
        933
      2. comment
        Participants were followed up after study drug discontinuation in double blind phase.
        group Id
        FG001
        num Subjects
        381
      3. comment
        Participants were followed up after study drug discontinuation in open label phase.
        group Id
        FG002
        num Subjects
        87
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        566
      2. group Id
        FG001
        num Subjects
        144
      3. group Id
        FG002
        num Subjects
        80
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        367
      2. group Id
        FG001
        num Subjects
        237
      3. group Id
        FG002
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Long-term Follow-up Phase
pre Assignment Details
A protocol amendment was implemented to unblind all participants and those who were previously treated with placebo had an opportunity to receive open-label access to enzalutamide at the discretion of the investigator.
recruitment Details
The study was conducted at 254 sites in 32 countries.
Complete source fields
groups
  1. description
    Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
    id
    FG000
    title
    Enzalutamide 160 mg
  2. description
    Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    id
    FG001
    title
    Placebo
  3. description
    Participants who received placebo in double-blind phase and who agreed to proceed to open-label phase, received 4 capsules of Enzalutamide 40 mg each (total dose of 160 mg per day), orally once daily (up to a maximum of 18.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    id
    FG002
    title
    Placebo Participants Crossover to Enzalutamide 160 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Violation
    3. reasons
      1. group Id
        FG000
        num Subjects
        71
      2. group Id
        FG001
        num Subjects
        47
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal Consent to Continue Treatment
    4. reasons
      1. group Id
        FG000
        num Subjects
        229
      2. group Id
        FG001
        num Subjects
        247
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease Progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        120
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      type
      Randomized But not Treated
    7. reasons
      1. group Id
        FG000
        num Subjects
        29
      2. group Id
        FG001
        num Subjects
        50
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        933
      2. group Id
        FG001
        num Subjects
        468
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        930
      2. group Id
        FG001
        num Subjects
        465
      3. group Id
        FG002
        num Subjects
        0
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        478
      2. group Id
        FG001
        num Subjects
        87
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        455
      2. group Id
        FG001
        num Subjects
        381
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Double-blind Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal Consent to Continue Treatment
    3. reasons
      1. group Id
        FG000
        num Subjects
        59
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Disease Progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        10
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        478
      2. comment
        Participants were offered to switch from double blind placebo to open label Enzalutamide.
        group Id
        FG001
        num Subjects
        0
      3. comment
        Participants previously treated with placebo, switched to receive open label Enzalutamide.
        group Id
        FG002
        num Subjects
        87
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        478
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        87
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        378
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        70
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        17
      type
      NOT COMPLETED
    title
    Open-label Phase
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        288
      2. group Id
        FG001
        num Subjects
        174
      3. group Id
        FG002
        num Subjects
        4
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        55
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrew Consent to Be Followed
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. comment
        Participants followed up after discontinuing study drug in either double blind or open label phase.
        group Id
        FG000
        num Subjects
        933
      2. comment
        Participants were followed up after study drug discontinuation in double blind phase.
        group Id
        FG001
        num Subjects
        381
      3. comment
        Participants were followed up after study drug discontinuation in open label phase.
        group Id
        FG002
        num Subjects
        87
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        566
      2. group Id
        FG001
        num Subjects
        144
      3. group Id
        FG002
        num Subjects
        80
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        367
      2. group Id
        FG001
        num Subjects
        237
      3. group Id
        FG002
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Long-term Follow-up Phase
pre Assignment Details
A protocol amendment was implemented to unblind all participants and those who were previously treated with placebo had an opportunity to receive open-label access to enzalutamide at the discretion of the investigator.
recruitment Details
The study was conducted at 254 sites in 32 countries.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice