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NCT02319837 · FLOW

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Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) · Source last updated 2026-07-09

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

groups
  1. description
    Participants were randomized to receive enzalutamide capsules 160 milligrams (mg)/day, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory prostate-specific antigen (PSA) evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
    id
    FG000
    title
    Enzalutamide + Leuprolide
  2. description
    Participants were randomized to receive placebo capsules once daily, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
    id
    FG001
    title
    Placebo + Leuprolide
  3. description
    Participants were randomized to receive enzalutamide capsules 160 mg/day from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
    id
    FG002
    title
    Enzalutamide Monotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        66
      3. group Id
        FG002
        num Subjects
        37
      type
      Centrally confirmed radiographic progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        5
      type
      PSA progression notification from sponsor
    3. reasons
      1. group Id
        FG000
        num Subjects
        73
      2. group Id
        FG001
        num Subjects
        36
      3. group Id
        FG002
        num Subjects
        63
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Development of castration resistance
    5. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        32
      3. group Id
        FG002
        num Subjects
        25
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    8. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        41
      3. group Id
        FG002
        num Subjects
        26
      type
      PI decision/disease progression by local conventional scan/PSA, and other miscellaneous reasons
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    10. reasons
      1. group Id
        FG000
        num Subjects
        207
      2. group Id
        FG001
        num Subjects
        153
      3. group Id
        FG002
        num Subjects
        197
      type
      Ongoing; still in treatment phase as of primary completion date (PCD) cutoff date 31 Jan 2023
    11. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      type
      Participants did not receive treatment.
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        355
      2. group Id
        FG001
        num Subjects
        358
      3. group Id
        FG002
        num Subjects
        355
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        353
      2. group Id
        FG001
        num Subjects
        354
      3. group Id
        FG002
        num Subjects
        354
      type
      Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        355
      2. group Id
        FG001
        num Subjects
        358
      3. group Id
        FG002
        num Subjects
        355
      type
      NOT COMPLETED
    title
    Study Treatment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        104
      3. group Id
        FG002
        num Subjects
        62
      type
      Ongoing; participants still in long-time follow-up phase as of the PCD cutoff date (31 January 2023)
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        12
      type
      PI decision, site closure and other miscellaneous reasons
    3. reasons
      1. group Id
        FG000
        num Subjects
        40
      2. group Id
        FG001
        num Subjects
        36
      3. group Id
        FG002
        num Subjects
        38
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        54
      3. group Id
        FG002
        num Subjects
        42
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        148
      2. group Id
        FG001
        num Subjects
        205
      3. group Id
        FG002
        num Subjects
        158
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        148
      2. group Id
        FG001
        num Subjects
        205
      3. group Id
        FG002
        num Subjects
        158
      type
      NOT COMPLETED
    title
    Long-Term Follow-Up Phase
pre Assignment Details
A total of 1068 participants were enrolled and randomized to the 3 treatment groups. There were 2 participants in the enzalutamide plus leuprolide group, 4 participants in the placebo plus leuprolide group, and 1 participant in the enzalutamide monotherapy group who did not receive any study intervention.
Complete source fields
groups
  1. description
    Participants were randomized to receive enzalutamide capsules 160 milligrams (mg)/day, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory prostate-specific antigen (PSA) evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
    id
    FG000
    title
    Enzalutamide + Leuprolide
  2. description
    Participants were randomized to receive placebo capsules once daily, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
    id
    FG001
    title
    Placebo + Leuprolide
  3. description
    Participants were randomized to receive enzalutamide capsules 160 mg/day from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
    id
    FG002
    title
    Enzalutamide Monotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        66
      3. group Id
        FG002
        num Subjects
        37
      type
      Centrally confirmed radiographic progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        20
      3. group Id
        FG002
        num Subjects
        5
      type
      PSA progression notification from sponsor
    3. reasons
      1. group Id
        FG000
        num Subjects
        73
      2. group Id
        FG001
        num Subjects
        36
      3. group Id
        FG002
        num Subjects
        63
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Development of castration resistance
    5. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        32
      3. group Id
        FG002
        num Subjects
        25
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    8. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        41
      3. group Id
        FG002
        num Subjects
        26
      type
      PI decision/disease progression by local conventional scan/PSA, and other miscellaneous reasons
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    10. reasons
      1. group Id
        FG000
        num Subjects
        207
      2. group Id
        FG001
        num Subjects
        153
      3. group Id
        FG002
        num Subjects
        197
      type
      Ongoing; still in treatment phase as of primary completion date (PCD) cutoff date 31 Jan 2023
    11. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        1
      type
      Participants did not receive treatment.
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        355
      2. group Id
        FG001
        num Subjects
        358
      3. group Id
        FG002
        num Subjects
        355
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        353
      2. group Id
        FG001
        num Subjects
        354
      3. group Id
        FG002
        num Subjects
        354
      type
      Received Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        355
      2. group Id
        FG001
        num Subjects
        358
      3. group Id
        FG002
        num Subjects
        355
      type
      NOT COMPLETED
    title
    Study Treatment Phase
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        67
      2. group Id
        FG001
        num Subjects
        104
      3. group Id
        FG002
        num Subjects
        62
      type
      Ongoing; participants still in long-time follow-up phase as of the PCD cutoff date (31 January 2023)
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        12
      type
      PI decision, site closure and other miscellaneous reasons
    3. reasons
      1. group Id
        FG000
        num Subjects
        40
      2. group Id
        FG001
        num Subjects
        36
      3. group Id
        FG002
        num Subjects
        38
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        54
      3. group Id
        FG002
        num Subjects
        42
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        148
      2. group Id
        FG001
        num Subjects
        205
      3. group Id
        FG002
        num Subjects
        158
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        148
      2. group Id
        FG001
        num Subjects
        205
      3. group Id
        FG002
        num Subjects
        158
      type
      NOT COMPLETED
    title
    Long-Term Follow-Up Phase
pre Assignment Details
A total of 1068 participants were enrolled and randomized to the 3 treatment groups. There were 2 participants in the enzalutamide plus leuprolide group, 4 participants in the placebo plus leuprolide group, and 1 participant in the enzalutamide monotherapy group who did not receive any study intervention.

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Preserved source evidence · Not medical advice