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NCT00451958 · STUDY IN CONTEXT

A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.

The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.

→

primary · POSTED

This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.

The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.

→

secondary · POSTED

PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).

CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail study (CS21).

→

secondary · POSTED

The results below present the percentage of participants of having testosterone \<=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study. In all treatment groups approximately 3% per year of the participants had at least one testosterone \>0.5 ng/mL during the study.

CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail CS21 study (NCT00295750).

→

secondary · POSTED

Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56

All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.

→

secondary · POSTED

Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56

All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-prostate-cancer
nct id
NCT00451958
trial label
A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
4
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0000
    source section id
    NCT00451958-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
    endpoint definition
    This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline (from main CS21 study, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A.
    time origin
    Up to 4 years of treatment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0001
    source section id
    NCT00451958-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
    endpoint definition
    This outcome measure included incidence of markedly abnormal changes in safety laboratory values. The table presents the number of participants with normal baseline (from main CS21 trial, NCT00295750) and at least one post-baseline markedly abnormal value during CS21A. Only the laboratory variables that had at least five percentages of participants in either group with abnormal value are presented, more variables were included in the study. ULN=Upper limit of normal.
    time origin
    Up to 4 years of treatment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population comprised all participants who were enrolled in the CS21A study and who received at least one dose of degarelix during the study period.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0002
    source section id
    NCT00451958-om-0002
    source outcome index
    2
    endpoint
    Percentage of Participants With no Prostate-specific Antigen (PSA) Progression
    endpoint definition
    PSA progression was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either CS21, NCT00295750, or CS21A). The figures below present the percentage of participants with no PSA progression at each of the selected time points (there were more time points in the study) along with corresponding 95% confidence intervals (CI).
    time origin
    Until all participants have received at least 5 years of treatment and at a frequency of every 3 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail study (CS21).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0003
    source section id
    NCT00451958-om-0003
    source outcome index
    3
    endpoint
    Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards
    endpoint definition
    The results below present the percentage of participants of having testosterone \<=0.5 ng/mL at each of the selected time points (there were more time points in the study) from Day 28 in CS21 (NCT00295750) until the end of the CS21A study. In all treatment groups approximately 3% per year of the participants had at least one testosterone \>0.5 ng/mL during the study.
    time origin
    Until all participants have received at least 5 years of treatment and at a frequency of every 6 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    CS21 ITT analysis set i.e. all participants who received at least one dose of degarelix or leuprolide during the mail CS21 study (NCT00295750).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0004
    source section id
    NCT00451958-om-0004
    source outcome index
    4
    endpoint
    Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56
    endpoint definition
    Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56
    time origin
    From time of switch to Day 56
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0005
    source section id
    NCT00451958-om-0005
    source outcome index
    5
    endpoint
    Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56
    endpoint definition
    Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56
    time origin
    From time of switch to Day 56
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants who received leuprolide in the main CS21 study (NCT00295750) and were switched over to degarelix in the CS21A extension study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Degarelix 80 mg / Degarelix 80 mg
    regimen
    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 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 study.
    analyzed count
    125
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00451958-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Degarelix 160 mg / Degarelix 160 mg
    regimen
    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 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. 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.
    analyzed count
    126
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00451958-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Leuprolide 7.5 mg / Degarelix 80 mg
    regimen
    During the main CS21 study, 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.
    analyzed count
    69
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00451958-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Leuprolide 7.5 mg / Degarelix 160 mg
    regimen
    During the main CS21 study, 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.
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00451958-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Degarelix 80 mg / Degarelix 80 mg
    regimen
    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 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 study.
    analyzed count
    125
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00451958-om-0001#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Degarelix 160 mg / Degarelix 160 mg
    regimen
    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 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. 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.
    analyzed count
    126
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00451958-om-0001#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Leuprolide 7.5 mg / Degarelix 80 mg
    regimen
    During the main CS21 study, 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.
    analyzed count
    69
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00451958-om-0001#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0001
    arm key
    OG003
    arm label
    Leuprolide 7.5 mg / Degarelix 160 mg
    regimen
    During the main CS21 study, 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.
    analyzed count
    65
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00451958-om-0001#groups/OG003
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Degarelix 80 mg / Degarelix 80 mg
    regimen
    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 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 study.
    analyzed count
    207
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00451958-om-0002#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Degarelix 160 mg / Degarelix 160 mg
    regimen
    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 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. 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.
    analyzed count
    202
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00451958-om-0002#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Leuprolide 7.5 mg / Degarelix 80 mg
    regimen
    During the main CS21 study, 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.
    analyzed count
    69
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00451958-om-0002#groups/OG002
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    outcome key
    om-0002
    arm key
    OG003
    arm label
    Leuprolide 7.5 mg / Degarelix 160 mg
    regimen
    During the main CS21 study, 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.
    analyzed count
    132
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00451958-om-0002#groups/OG003
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    harm key
    EG000
    source section id
    NCT00451958-ae
    event group key
    EG000
    event group label
    Degarelix 80 mg / Degarelix 80 mg
    serious affected
    43
    serious at risk
    207
    other affected
    181
    other at risk
    207
    frequency threshold
    5
    collection period
    From start of CS21A and up to 4.5 years.
    event definition
    The population comprised all participants who were enrolled into CS21A and who received at least one dose of degarelix during the study.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    harm key
    EG001
    source section id
    NCT00451958-ae
    event group key
    EG001
    event group label
    Degarelix 160 mg / Degarelix 160 mg
    serious affected
    60
    serious at risk
    202
    other affected
    177
    other at risk
    202
    frequency threshold
    5
    collection period
    From start of CS21A and up to 4.5 years.
    event definition
    The population comprised all participants who were enrolled into CS21A and who received at least one dose of degarelix during the study.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    harm key
    EG002
    source section id
    NCT00451958-ae
    event group key
    EG002
    event group label
    Leuprolide 7.5 mg / Degarelix 80 mg
    serious affected
    23
    serious at risk
    69
    other affected
    63
    other at risk
    69
    frequency threshold
    5
    collection period
    From start of CS21A and up to 4.5 years.
    event definition
    The population comprised all participants who were enrolled into CS21A and who received at least one dose of degarelix during the study.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-prostate-cancer
    nct id
    NCT00451958
    harm key
    EG003
    source section id
    NCT00451958-ae
    event group key
    EG003
    event group label
    Leuprolide 7.5 mg / Degarelix 160 mg
    serious affected
    22
    serious at risk
    66
    other affected
    58
    other at risk
    66
    frequency threshold
    5
    collection period
    From start of CS21A and up to 4.5 years.
    event definition
    The population comprised all participants who were enrolled into CS21A and who received at least one dose of degarelix during the study.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice