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NCT01715285 · FLOW

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A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC) · Source last updated 2025-02-04

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

groups
  1. description
    Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
    id
    FG000
    title
    Abiraterone Acetate+Prednisone+ADT
  2. description
    Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
    id
    FG001
    title
    Placebo + ADT
  3. description
    Participants who were originally randomized to the Placebo group were permitted to crossover to Abiraterone Acetate plus Prednisone treatment in open-label extension phase to receive abiraterone acetate tablet at a total dose of 1000 mg plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
    id
    FG002
    title
    DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        53
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        47
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        254
      2. group Id
        FG001
        num Subjects
        388
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive Disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Noncompliance With Study Drug
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        72
      3. group Id
        FG002
        num Subjects
        0
      type
      Placebo Cross-Over
    9. reasons
      1. group Id
        FG000
        num Subjects
        167
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        597
      2. group Id
        FG001
        num Subjects
        602
      3. group Id
        FG002
        num Subjects
        0
      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
        597
      2. group Id
        FG001
        num Subjects
        602
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Double Blind Period (Up to 23 Months)
  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
        4
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        60
      type
      Other
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. comment
        Post unblinding, participants crossed over to OLE Phase.
        group Id
        FG002
        num Subjects
        72
      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
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        72
      type
      NOT COMPLETED
    title
    OLE Phase (Up to 15.6 Months)
pre Assignment Details
1209 participants were enrolled and 1199 were randomized to treatment groups.10 participants from Russian site were excluded from the analysis due to noncompliance with International Conference on Harmonization Good Clinical Practice guidelines at site. The remaining 1199 randomized participants comprised the intent-to-treat population.
Complete source fields
groups
  1. description
    Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
    id
    FG000
    title
    Abiraterone Acetate+Prednisone+ADT
  2. description
    Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
    id
    FG001
    title
    Placebo + ADT
  3. description
    Participants who were originally randomized to the Placebo group were permitted to crossover to Abiraterone Acetate plus Prednisone treatment in open-label extension phase to receive abiraterone acetate tablet at a total dose of 1000 mg plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
    id
    FG002
    title
    DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        53
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        52
      2. group Id
        FG001
        num Subjects
        47
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        254
      2. group Id
        FG001
        num Subjects
        388
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive Disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Noncompliance With Study Drug
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        72
      3. group Id
        FG002
        num Subjects
        0
      type
      Placebo Cross-Over
    9. reasons
      1. group Id
        FG000
        num Subjects
        167
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        597
      2. group Id
        FG001
        num Subjects
        602
      3. group Id
        FG002
        num Subjects
        0
      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
        597
      2. group Id
        FG001
        num Subjects
        602
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Double Blind Period (Up to 23 Months)
  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
        4
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        60
      type
      Other
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. comment
        Post unblinding, participants crossed over to OLE Phase.
        group Id
        FG002
        num Subjects
        72
      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
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        72
      type
      NOT COMPLETED
    title
    OLE Phase (Up to 15.6 Months)
pre Assignment Details
1209 participants were enrolled and 1199 were randomized to treatment groups.10 participants from Russian site were excluded from the analysis due to noncompliance with International Conference on Harmonization Good Clinical Practice guidelines at site. The remaining 1199 randomized participants comprised the intent-to-treat population.

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Preserved source evidence · Not medical advice