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NCT03511664 · BASELINE

Baseline characteristics

Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer · Source last updated 2025-01-13

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
      551
    2. group Id
      BG001
      value
      280
    3. group Id
      BG002
      value
      30
    4. group Id
      BG003
      value
      861
    units
    Participants
groups
  1. description
    Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used
    id
    BG000
    title
    Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
  2. description
    Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
    id
    BG001
    title
    Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
  3. description
    non-randomized cohort (AAA617+ BS/BSOC) at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Patients were treated and followed up similarly to the AAA617+BSC/BSOC (investigational arm) patients in the main study
    id
    BG002
    title
    Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          145
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          217
        title
        < 65 years
      2. measurements
        1. group Id
          BG000
          value
          398
        2. group Id
          BG001
          value
          214
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          630
        title
        ≥ 65-84 years
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          14
        title
        ≥ 85 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          551
        2. group Id
          BG001
          value
          280
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          861
        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
          486
        2. group Id
          BG001
          value
          235
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          751
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          55
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          20
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      Other
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          33
      title
      Missing
    description
    Race 'Other' included Native Hawaiian or Other Pacific Islander, American Indian or Alaska Native and more than one race reported.
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      551
    2. group Id
      BG001
      value
      280
    3. group Id
      BG002
      value
      30
    4. group Id
      BG003
      value
      861
    units
    Participants
groups
  1. description
    Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used
    id
    BG000
    title
    Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
  2. description
    Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator
    id
    BG001
    title
    Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone
  3. description
    non-randomized cohort (AAA617+ BS/BSOC) at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Patients were treated and followed up similarly to the AAA617+BSC/BSOC (investigational arm) patients in the main study
    id
    BG002
    title
    Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          145
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          217
        title
        < 65 years
      2. measurements
        1. group Id
          BG000
          value
          398
        2. group Id
          BG001
          value
          214
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          630
        title
        ≥ 65-84 years
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          14
        title
        ≥ 85 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          551
        2. group Id
          BG001
          value
          280
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          861
        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
          486
        2. group Id
          BG001
          value
          235
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          751
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          55
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          20
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
      title
      Other
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          33
      title
      Missing
    description
    Race 'Other' included Native Hawaiian or Other Pacific Islander, American Indian or Alaska Native and more than one race reported.
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice