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NCT04689828 · BASELINE

Baseline characteristics

177Lu-PSMA-617 vs. Androgen Receptor-Directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer · Source last updated 2026-08-26

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
      234
    2. group Id
      BG001
      value
      234
    3. group Id
      BG002
      value
      468
    units
    Participants
groups
  1. description
    Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.
    id
    BG000
    title
    177Lu-PSMA-617 (AAA617)
  2. description
    For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.
    id
    BG001
    title
    Androgen Receptor-directed Therapy (ARDT)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.70
          value
          71.0
        2. group Id
          BG001
          spread
          7.65
          value
          71.9
        3. group Id
          BG002
          spread
          8.19
          value
          71.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  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
          234
        2. group Id
          BG001
          value
          234
        3. group Id
          BG002
          value
          468
        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
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          212
        2. group Id
          BG001
          value
          214
        3. group Id
          BG002
          value
          426
      title
      White
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          27
      title
      Unknown
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Full Analysis Set (FAS) comprised all participants to whom study treatment was assigned by randomization.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      234
    2. group Id
      BG001
      value
      234
    3. group Id
      BG002
      value
      468
    units
    Participants
groups
  1. description
    Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.
    id
    BG000
    title
    177Lu-PSMA-617 (AAA617)
  2. description
    For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.
    id
    BG001
    title
    Androgen Receptor-directed Therapy (ARDT)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.70
          value
          71.0
        2. group Id
          BG001
          spread
          7.65
          value
          71.9
        3. group Id
          BG002
          spread
          8.19
          value
          71.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  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
          234
        2. group Id
          BG001
          value
          234
        3. group Id
          BG002
          value
          468
        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
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          212
        2. group Id
          BG001
          value
          214
        3. group Id
          BG002
          value
          426
      title
      White
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          27
      title
      Unknown
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Full Analysis Set (FAS) comprised all participants to whom study treatment was assigned by randomization.

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Preserved source evidence · Not medical advice