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A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy · Source last updated 2013-03-21

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

groups
  1. description
    The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study.
    id
    FG000
    title
    Degarelix 80 mg / Degarelix 80 mg
  2. description
    The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    id
    FG001
    title
    Degarelix 160 mg / Degarelix 160 mg
  3. description
    During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    id
    FG002
    title
    Leuprolide 7.5 mg / Degarelix 80 mg
  4. description
    During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    id
    FG003
    title
    Leuprolide 7.5 mg / Degarelix 160 mg
  5. description
    During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. When the main CS21 study was completed these patients were switched to treatment with degarelix 80 mg or 160 mg in the CS21A study.
    id
    FG004
    title
    Leuprolide 7.5 mg
periods
  1. milestones
    1. achievements
      1. comment
        CS21 intention-to-treat (ITT) population.
        group Id
        FG000
        num Subjects
        210
      2. comment
        CS21 ITT population.
        group Id
        FG001
        num Subjects
        206
      3. comment
        Participants were switched from the leuprolide 7.5 mg group when CS21 was completed.
        group Id
        FG002
        num Subjects
        0
      4. comment
        Participants were switched from the leuprolide 7.5 mg group when CS21 was completed.
        group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        204
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        169
      2. group Id
        FG001
        num Subjects
        163
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        172
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        43
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        32
      type
      NOT COMPLETED
    title
    CS21 (NCT00295750)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        17
      5. group Id
        FG004
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        14
      5. group Id
        FG004
        num Subjects
        0
      type
      Miscellaneous reasons
    milestones
    1. achievements
      1. comment
        CS21A intention-to-treat (ITT) population.
        group Id
        FG000
        num Subjects
        125
      2. comment
        CS21A ITT population.
        group Id
        FG001
        num Subjects
        126
      3. comment
        CS21A ITT population.
        group Id
        FG002
        num Subjects
        69
      4. comment
        One of the enrolled participants never received any treatment, i.e. the CS21A ITT population=65.
        group Id
        FG003
        num Subjects
        66
      5. comment
        Participants were switched to the degarelix groups when CS21 was completed.
        group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        60
      2. group Id
        FG001
        num Subjects
        49
      3. group Id
        FG002
        num Subjects
        27
      4. group Id
        FG003
        num Subjects
        27
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        65
      2. group Id
        FG001
        num Subjects
        77
      3. group Id
        FG002
        num Subjects
        42
      4. group Id
        FG003
        num Subjects
        39
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    CS21A (NCT00451958)
pre Assignment Details
Initially, participants treated with degarelix during CS21 continued to treatment and patients who received treatment with leuprolide during CS21 were re-randomised to one of the two degarelix treatment regimens. Following a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg for the rest of the study.
recruitment Details
All participants who completed the CS21 study (NCT00295750) were eligible to enrol into the CS21A extension study. Since the number of participants who completed this long-term study was low, no firm conclusions can be drawn from the results.
Complete source fields
groups
  1. description
    The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study.
    id
    FG000
    title
    Degarelix 80 mg / Degarelix 80 mg
  2. description
    The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    id
    FG001
    title
    Degarelix 160 mg / Degarelix 160 mg
  3. description
    During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    id
    FG002
    title
    Leuprolide 7.5 mg / Degarelix 80 mg
  4. description
    During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study. Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
    id
    FG003
    title
    Leuprolide 7.5 mg / Degarelix 160 mg
  5. description
    During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year. When the main CS21 study was completed these patients were switched to treatment with degarelix 80 mg or 160 mg in the CS21A study.
    id
    FG004
    title
    Leuprolide 7.5 mg
periods
  1. milestones
    1. achievements
      1. comment
        CS21 intention-to-treat (ITT) population.
        group Id
        FG000
        num Subjects
        210
      2. comment
        CS21 ITT population.
        group Id
        FG001
        num Subjects
        206
      3. comment
        Participants were switched from the leuprolide 7.5 mg group when CS21 was completed.
        group Id
        FG002
        num Subjects
        0
      4. comment
        Participants were switched from the leuprolide 7.5 mg group when CS21 was completed.
        group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        204
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        169
      2. group Id
        FG001
        num Subjects
        163
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        172
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        43
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        32
      type
      NOT COMPLETED
    title
    CS21 (NCT00295750)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        17
      5. group Id
        FG004
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        28
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        17
      4. group Id
        FG003
        num Subjects
        14
      5. group Id
        FG004
        num Subjects
        0
      type
      Miscellaneous reasons
    milestones
    1. achievements
      1. comment
        CS21A intention-to-treat (ITT) population.
        group Id
        FG000
        num Subjects
        125
      2. comment
        CS21A ITT population.
        group Id
        FG001
        num Subjects
        126
      3. comment
        CS21A ITT population.
        group Id
        FG002
        num Subjects
        69
      4. comment
        One of the enrolled participants never received any treatment, i.e. the CS21A ITT population=65.
        group Id
        FG003
        num Subjects
        66
      5. comment
        Participants were switched to the degarelix groups when CS21 was completed.
        group Id
        FG004
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        60
      2. group Id
        FG001
        num Subjects
        49
      3. group Id
        FG002
        num Subjects
        27
      4. group Id
        FG003
        num Subjects
        27
      5. group Id
        FG004
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        65
      2. group Id
        FG001
        num Subjects
        77
      3. group Id
        FG002
        num Subjects
        42
      4. group Id
        FG003
        num Subjects
        39
      5. group Id
        FG004
        num Subjects
        0
      type
      NOT COMPLETED
    title
    CS21A (NCT00451958)
pre Assignment Details
Initially, participants treated with degarelix during CS21 continued to treatment and patients who received treatment with leuprolide during CS21 were re-randomised to one of the two degarelix treatment regimens. Following a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg for the rest of the study.
recruitment Details
All participants who completed the CS21 study (NCT00295750) were eligible to enrol into the CS21A extension study. Since the number of participants who completed this long-term study was low, no firm conclusions can be drawn from the results.

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Preserved source evidence · Not medical advice