Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02294461 · FLOW

Participant flow

An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants · Source last updated 2025-10-24

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

groups
  1. description
    Participants received 160 milligrams (mg) of enzalutamide orally once a day during double blind period until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months).
    id
    FG000
    title
    Enzalutamide
  2. description
    Participants received enzalutamide matching placebo orally once a day during double-blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 18.6 months).
    id
    FG001
    title
    Placebo
  3. description
    Eligible participants who received enzalutamide matching placebo during Double Blind period and who provided consent to take part in Open label period, received 160 mg of enzalutamide orally once a day during open-label period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 53.8 months).
    id
    FG002
    title
    Placebo Patients Crossover to Enzalutamide 160 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        66
      3. group Id
        FG002
        num Subjects
        0
      type
      Miscellaneous
    3. reasons
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        54
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Deviation
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        51
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive Disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        202
      2. group Id
        FG001
        num Subjects
        193
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        202
      2. group Id
        FG001
        num Subjects
        193
      3. group Id
        FG002
        num Subjects
        0
      type
      Treated/Received Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        84
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        118
      2. group Id
        FG001
        num Subjects
        192
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Double-blind Period (up to 29.4 Months)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        16
      type
      Miscellaneous
    2. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        10
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Deviation
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        12
      type
      Progressive Disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      type
      Adverse Event
    milestones
    1. achievements
      1. comment
        Eligible participants who provided consent took part in open-label period.
        group Id
        FG000
        num Subjects
        85
      2. comment
        Eligible participants who provided consent took part in open-label period.
        group Id
        FG001
        num Subjects
        0
      3. comment
        Eligible participants who provided consent took part in open-label period.
        group Id
        FG002
        num Subjects
        51
      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
        85
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        51
      type
      NOT COMPLETED
    title
    Open-label Period (up to 54.3 Months)
pre Assignment Details
Participants who met inclusion criteria and none of the exclusion criteria were enrolled in the study.
recruitment Details
The study population consisted of men with asymptomatic or mildly symptomatic progressive metastatic prostate cancer, who had failed androgen deprivation therapy, and have not been treated with cytotoxic chemotherapy. Participants from 46 study sites in 4 countries (China, Korea, Taiwan and Hong Kong) were randomized for the study.
Complete source fields
groups
  1. description
    Participants received 160 milligrams (mg) of enzalutamide orally once a day during double blind period until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months).
    id
    FG000
    title
    Enzalutamide
  2. description
    Participants received enzalutamide matching placebo orally once a day during double-blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 18.6 months).
    id
    FG001
    title
    Placebo
  3. description
    Eligible participants who received enzalutamide matching placebo during Double Blind period and who provided consent to take part in Open label period, received 160 mg of enzalutamide orally once a day during open-label period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 53.8 months).
    id
    FG002
    title
    Placebo Patients Crossover to Enzalutamide 160 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        66
      3. group Id
        FG002
        num Subjects
        0
      type
      Miscellaneous
    3. reasons
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        54
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Deviation
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        38
      2. group Id
        FG001
        num Subjects
        51
      3. group Id
        FG002
        num Subjects
        0
      type
      Progressive Disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        15
      3. group Id
        FG002
        num Subjects
        0
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        202
      2. group Id
        FG001
        num Subjects
        193
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        202
      2. group Id
        FG001
        num Subjects
        193
      3. group Id
        FG002
        num Subjects
        0
      type
      Treated/Received Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        84
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        118
      2. group Id
        FG001
        num Subjects
        192
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Double-blind Period (up to 29.4 Months)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        16
      type
      Miscellaneous
    2. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        10
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol Deviation
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        12
      type
      Progressive Disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      type
      Adverse Event
    milestones
    1. achievements
      1. comment
        Eligible participants who provided consent took part in open-label period.
        group Id
        FG000
        num Subjects
        85
      2. comment
        Eligible participants who provided consent took part in open-label period.
        group Id
        FG001
        num Subjects
        0
      3. comment
        Eligible participants who provided consent took part in open-label period.
        group Id
        FG002
        num Subjects
        51
      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
        85
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        51
      type
      NOT COMPLETED
    title
    Open-label Period (up to 54.3 Months)
pre Assignment Details
Participants who met inclusion criteria and none of the exclusion criteria were enrolled in the study.
recruitment Details
The study population consisted of men with asymptomatic or mildly symptomatic progressive metastatic prostate cancer, who had failed androgen deprivation therapy, and have not been treated with cytotoxic chemotherapy. Participants from 46 study sites in 4 countries (China, Korea, Taiwan and Hong Kong) were randomized for the study.

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

Preserved source evidence · Not medical advice