TriangleNCT00451958 · CITED IN SOURCE DOCUMENTS
A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2013-03-21
Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Percentage of Participants With no Prostate-specific Antigen (PSA) Progression
Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards
Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56
Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56
Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56
Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion/Exclusion Criteria: * Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated. * Signed informed consent * The patients must have completed the FE 200486 CS21 Study.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- MALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- 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 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.
- intervention Names
- Drug: Degarelix 80 mg / Degarelix 80 mg
- label
- Degarelix 80 mg / Degarelix 80 mg
- type
- EXPERIMENTAL
- 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 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.
- intervention Names
- Drug: Degarelix 160 mg / Degarelix 160 mg
- label
- Degarelix 160 mg / Degarelix 160 mg
- type
- EXPERIMENTAL
- description
- 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.
- intervention Names
- Drug: Leuprolide 7.5 mg / Degarelix 80 mg
- label
- Leuprolide 7.5 mg / Degarelix 80 mg
- type
- EXPERIMENTAL
- description
- 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.
- intervention Names
- Drug: Leuprolide 7.5 mg / Degarelix 160 mg
- label
- Leuprolide 7.5 mg / Degarelix 160 mg
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Degarelix 80 mg / Degarelix 80 mg
- name
- Degarelix 80 mg / Degarelix 80 mg
- other Names
- Firmagon
- type
- DRUG
- arm Group Labels
- Degarelix 160 mg / Degarelix 160 mg
- name
- Degarelix 160 mg / Degarelix 160 mg
- other Names
- Firmagon
- type
- DRUG
- arm Group Labels
- Leuprolide 7.5 mg / Degarelix 80 mg
- name
- Leuprolide 7.5 mg / Degarelix 80 mg
- other Names
- Firmagon
- Lupron
- type
- DRUG
- arm Group Labels
- Leuprolide 7.5 mg / Degarelix 160 mg
- name
- Leuprolide 7.5 mg / Degarelix 160 mg
- other Names
- Firmagon
- Lupron
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 386
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
- time Frame
- Up to 4 years of treatment
- description
- 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.
- measure
- Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
- time Frame
- Up to 4 years of treatment
- secondary Outcomes
- description
- 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).
- measure
- Percentage of Participants With no Prostate-specific Antigen (PSA) Progression
- time Frame
- Until all participants have received at least 5 years of treatment and at a frequency of every 3 months
- description
- 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.
- measure
- Percentage of Participants With Testosterone Level Maintained at <=0.5 ng/mL From Day 28 in CS21 and Onwards
- time Frame
- Until all participants have received at least 5 years of treatment and at a frequency of every 6 months
- measure
- Serum Levels of Testosterone From the Time of Switch From Leuprolide to Degarelix up to Day 56
- time Frame
- From time of switch to Day 56
- measure
- Serum Levels of PSA From the Time of Switch From Leuprolide to Degarelix to Day 56
- time Frame
- From time of switch to Day 56
- measure
- Serum Levels of Luteinizing Hormone (LH) From the Time of Switch From Leuprolide to Degarelix to Day 56
- time Frame
- From time of switch to Day 56
- measure
- Serum Levels of Follicle Stimulating Hormone (FSH) From the Time of Switch From Leuprolide to Degarelix to Day 56
- time Frame
- From time of switch to Day 56
Full study description
- brief Summary
- Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.
Source references
- references
- citation
- Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
- pmid
- 34350976
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- urred in less than 1% of patients. FIRMAGON Extension Study The safety of FIRMAGON administered once every 28 days was evaluated further in an extension study (NCT00451958) in 385 patients who completed the above active-controlled trial. Of the 385 patients, 251 patients continued treatment with FIRMAGON and 135 patients crossed
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Preserved source evidence · Not medical advice