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NCT02677896 · BASELINE

Baseline characteristics

A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) · Source last updated 2025-10-24

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

denoms
  1. counts
    1. group Id
      BG000
      value
      574
    2. group Id
      BG001
      value
      576
    3. group Id
      BG002
      value
      1150
    units
    Participants
groups
  1. description
    Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
    id
    BG000
    title
    Enzalutamide + Androgen Deprivation Therapy (ADT)
  2. description
    Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
    id
    BG001
    title
    Placebo + Androgen Deprivation Therapy (ADT)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.0
          value
          69.5
        2. group Id
          BG001
          spread
          8.4
          value
          69.5
        3. group Id
          BG002
          spread
          8.2
          value
          69.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    year
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          574
        2. group Id
          BG001
          value
          576
        3. group Id
          BG002
          value
          1150
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          83
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          504
        2. group Id
          BG001
          value
          514
        3. group Id
          BG002
          value
          1018
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          49
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          155
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          466
        2. group Id
          BG001
          value
          460
        3. group Id
          BG002
          value
          926
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          53
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          220
        2. group Id
          BG001
          value
          203
        3. group Id
          BG002
          value
          423
        title
        Low
      2. measurements
        1. group Id
          BG000
          value
          354
        2. group Id
          BG001
          value
          373
        3. group Id
          BG002
          value
          727
        title
        High
    description
    High volume of disease was defined as metastases involving the viscera or, in the absence of visceral lesions, 4 or more bone lesions, at least 1 of which was in a bony structure beyond the vertebral column and pelvic bone. Low volume was anything that wasn't considered high volume by definition provided.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Intent-to-Treat (ITT)
    title
    Volume of Disease
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          471
        2. group Id
          BG001
          value
          474
        3. group Id
          BG002
          value
          945
        title
        None
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          25
        title
        1 to 5 cycles
      3. measurements
        1. group Id
          BG000
          value
          89
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          180
        title
        6 cycles
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    ITT
    title
    Prior Docetaxel Therapy Use
    unit Of Measure
    Participants
population Description
All Randomized Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      574
    2. group Id
      BG001
      value
      576
    3. group Id
      BG002
      value
      1150
    units
    Participants
groups
  1. description
    Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
    id
    BG000
    title
    Enzalutamide + Androgen Deprivation Therapy (ADT)
  2. description
    Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
    id
    BG001
    title
    Placebo + Androgen Deprivation Therapy (ADT)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.0
          value
          69.5
        2. group Id
          BG001
          spread
          8.4
          value
          69.5
        3. group Id
          BG002
          spread
          8.2
          value
          69.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    year
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          574
        2. group Id
          BG001
          value
          576
        3. group Id
          BG002
          value
          1150
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          83
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          504
        2. group Id
          BG001
          value
          514
        3. group Id
          BG002
          value
          1018
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          49
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          155
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          466
        2. group Id
          BG001
          value
          460
        3. group Id
          BG002
          value
          926
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          53
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          220
        2. group Id
          BG001
          value
          203
        3. group Id
          BG002
          value
          423
        title
        Low
      2. measurements
        1. group Id
          BG000
          value
          354
        2. group Id
          BG001
          value
          373
        3. group Id
          BG002
          value
          727
        title
        High
    description
    High volume of disease was defined as metastases involving the viscera or, in the absence of visceral lesions, 4 or more bone lesions, at least 1 of which was in a bony structure beyond the vertebral column and pelvic bone. Low volume was anything that wasn't considered high volume by definition provided.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Intent-to-Treat (ITT)
    title
    Volume of Disease
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          471
        2. group Id
          BG001
          value
          474
        3. group Id
          BG002
          value
          945
        title
        None
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          25
        title
        1 to 5 cycles
      3. measurements
        1. group Id
          BG000
          value
          89
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          180
        title
        6 cycles
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    ITT
    title
    Prior Docetaxel Therapy Use
    unit Of Measure
    Participants
population Description
All Randomized Participants

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

Preserved source evidence · Not medical advice