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NCT02975934 · BASELINE

Baseline characteristics

A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency · Source last updated 2025-07-25

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
      270
    2. group Id
      BG001
      value
      135
    3. group Id
      BG002
      value
      405
    units
    Participants
groups
  1. description
    Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily.
    id
    BG000
    title
    Rucaparib
  2. description
    Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
    id
    BG001
    title
    Abiraterone Acetate or Enzalutamide or Docetaxel
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          116
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          289
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          45
          upper Limit
          90
          value
          70
        2. group Id
          BG001
          lower Limit
          47
          upper Limit
          92
          value
          71
        3. group Id
          BG002
          lower Limit
          45
          upper Limit
          92
          value
          70
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. 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
          270
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          405
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          216
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          319
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          79
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        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
          10
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          14
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          199
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          302
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          80
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          111
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          167
      title
      North America
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          141
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          214
      title
      Europe
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          13
      title
      Australia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          11
      title
      Israel
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          200
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          205
        title
        1
    description
    Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance Status Scale. ECOG 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work or office work)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status (at stratification)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          44
        title
        BRCA1
      2. measurements
        1. group Id
          BG000
          value
          172
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          258
        title
        BRCA2
      3. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          103
        title
        ATM
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gene Alteration (at stratification)
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.1
          upper Limit
          1247
          value
          26.9
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          1039
          value
          28.8
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          1247
          value
          27.8
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Baseline prostate specific antigen (PSA)
    unit Of Measure
    ng/ml
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          173
        2. group Id
          BG001
          value
          96
        3. group Id
          BG002
          value
          269
    description
    The scale for the Gleason score ranges from 2 to 10, with higher scores indicating a worse prognosis
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gleason score ≥8 at diagnosis
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          106
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          161
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Measurable Disease per Independent Radiological Review (IRR)
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          235
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          349
      title
      Bone
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          178
      title
      Nodal
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          120
      title
      Visceral
    description
    Participants may be counted in more than one category
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Metastases site(s) by IRR
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) Population included all randomized participants (participants with breast cancer gene \[BRCA\] mutated metastatic castration-resistant prostate cancer \[mCRPC\] and participants with ataxia- telangiectasia mutated serine/threonine kinase \[ATM\] mutated mCRPC).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      270
    2. group Id
      BG001
      value
      135
    3. group Id
      BG002
      value
      405
    units
    Participants
groups
  1. description
    Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily.
    id
    BG000
    title
    Rucaparib
  2. description
    Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
    id
    BG001
    title
    Abiraterone Acetate or Enzalutamide or Docetaxel
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          116
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          186
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          289
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          45
          upper Limit
          90
          value
          70
        2. group Id
          BG001
          lower Limit
          47
          upper Limit
          92
          value
          71
        3. group Id
          BG002
          lower Limit
          45
          upper Limit
          92
          value
          70
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. 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
          270
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          405
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          216
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          319
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          79
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        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
          10
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          14
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          199
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          302
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          80
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          111
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          167
      title
      North America
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          141
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          214
      title
      Europe
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          13
      title
      Australia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          11
      title
      Israel
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          200
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          205
        title
        1
    description
    Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance Status Scale. ECOG 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work or office work)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status (at stratification)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          44
        title
        BRCA1
      2. measurements
        1. group Id
          BG000
          value
          172
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          258
        title
        BRCA2
      3. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          103
        title
        ATM
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gene Alteration (at stratification)
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.1
          upper Limit
          1247
          value
          26.9
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          1039
          value
          28.8
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          1247
          value
          27.8
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Baseline prostate specific antigen (PSA)
    unit Of Measure
    ng/ml
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          173
        2. group Id
          BG001
          value
          96
        3. group Id
          BG002
          value
          269
    description
    The scale for the Gleason score ranges from 2 to 10, with higher scores indicating a worse prognosis
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gleason score ≥8 at diagnosis
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          106
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          161
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Measurable Disease per Independent Radiological Review (IRR)
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          235
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          349
      title
      Bone
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          178
      title
      Nodal
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          120
      title
      Visceral
    description
    Participants may be counted in more than one category
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Metastases site(s) by IRR
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) Population included all randomized participants (participants with breast cancer gene \[BRCA\] mutated metastatic castration-resistant prostate cancer \[mCRPC\] and participants with ataxia- telangiectasia mutated serine/threonine kinase \[ATM\] mutated mCRPC).

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