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NCT00309985 · FLOW

Participant flow

Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer · Source last updated 2025-12-11

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

groups
  1. description
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Androgen-Deprivation Therapy and Docetaxel
  2. description
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
    id
    FG001
    title
    Androgen-Deprivation Therapy Alone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        0
      type
      Never started treatment
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Complicating disease
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Non-compliance
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Chemotherapy discontinued only
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        397
      2. group Id
        FG001
        num Subjects
        393
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        390
      2. group Id
        FG001
        num Subjects
        392
      type
      Toxicity Analysis
    3. achievements
      1. group Id
        FG000
        num Subjects
        334
      2. group Id
        FG001
        num Subjects
        299
      type
      Both Baseline and 3-month FACT-P Evals
    4. achievements
      1. group Id
        FG000
        num Subjects
        335
      2. comment
        Arm B tx info was not collected so only 1 patient w/o follow-up data was considered "not completed".
        group Id
        FG001
        num Subjects
        392
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        62
      2. group Id
        FG001
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This study was activated on July 28, 2006, accrued its first patient on September 26, 2006, and closed to accrual on November 21, 2012, after accrual of 790 patients.
Complete source fields
groups
  1. description
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Androgen-Deprivation Therapy and Docetaxel
  2. description
    Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration).
    id
    FG001
    title
    Androgen-Deprivation Therapy Alone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        0
      type
      Never started treatment
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Complicating disease
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Non-compliance
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Chemotherapy discontinued only
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        397
      2. group Id
        FG001
        num Subjects
        393
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        390
      2. group Id
        FG001
        num Subjects
        392
      type
      Toxicity Analysis
    3. achievements
      1. group Id
        FG000
        num Subjects
        334
      2. group Id
        FG001
        num Subjects
        299
      type
      Both Baseline and 3-month FACT-P Evals
    4. achievements
      1. group Id
        FG000
        num Subjects
        335
      2. comment
        Arm B tx info was not collected so only 1 patient w/o follow-up data was considered "not completed".
        group Id
        FG001
        num Subjects
        392
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        62
      2. group Id
        FG001
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This study was activated on July 28, 2006, accrued its first patient on September 26, 2006, and closed to accrual on November 21, 2012, after accrual of 790 patients.

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Preserved source evidence · Not medical advice