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NCT02975934 · FLOW

Participant flow

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.

groups
  1. description
    Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily.
    id
    FG000
    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
    FG001
    title
    Abiraterone Acetate or Enzalutamide or Docetaxel
  3. description
    Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily. Participants from the Abiraterone Acetate/Enzalutamide/Docetaxel arm who completed the Treatment Phase and radiographically progressed by independent radiology review (IRR) may receive rucaparib treatment during the Cross-Over Phase. After analysis of the primary endpoint, investigator-assessed radiographic disease progression will be used for cross-over eligibility evaluation.
    id
    FG002
    title
    Rucaparib (Cross-Over Phase)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      type
      Never initiated study drug
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        270
      2. group Id
        FG001
        num Subjects
        135
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        270
      2. group Id
        FG001
        num Subjects
        130
      3. group Id
        FG002
        num Subjects
        0
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        270
      2. group Id
        FG001
        num Subjects
        130
      3. group Id
        FG002
        num Subjects
        0
      type
      Safety Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        270
      2. group Id
        FG001
        num Subjects
        130
      3. group Id
        FG002
        num Subjects
        0
      comment
      Treatment period completion was defined as discontinuation when criteria for treatment discontinuation were met.
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Treatment Phase
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        70
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        70
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        70
      type
      Safety Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        70
      comment
      Crossover period completion was defined as discontinuation when criteria for treatment discontinuation were met, or study closure.
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Cross-Over Phase
Complete source fields
groups
  1. description
    Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily.
    id
    FG000
    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
    FG001
    title
    Abiraterone Acetate or Enzalutamide or Docetaxel
  3. description
    Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily. Participants from the Abiraterone Acetate/Enzalutamide/Docetaxel arm who completed the Treatment Phase and radiographically progressed by independent radiology review (IRR) may receive rucaparib treatment during the Cross-Over Phase. After analysis of the primary endpoint, investigator-assessed radiographic disease progression will be used for cross-over eligibility evaluation.
    id
    FG002
    title
    Rucaparib (Cross-Over Phase)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      type
      Never initiated study drug
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        270
      2. group Id
        FG001
        num Subjects
        135
      3. group Id
        FG002
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        270
      2. group Id
        FG001
        num Subjects
        130
      3. group Id
        FG002
        num Subjects
        0
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        270
      2. group Id
        FG001
        num Subjects
        130
      3. group Id
        FG002
        num Subjects
        0
      type
      Safety Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        270
      2. group Id
        FG001
        num Subjects
        130
      3. group Id
        FG002
        num Subjects
        0
      comment
      Treatment period completion was defined as discontinuation when criteria for treatment discontinuation were met.
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Treatment Phase
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        70
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        70
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        70
      type
      Safety Population
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        70
      comment
      Crossover period completion was defined as discontinuation when criteria for treatment discontinuation were met, or study closure.
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Cross-Over Phase

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Preserved source evidence · Not medical advice