TriangleNCT00295750 · CITED IN SOURCE DOCUMENTS
The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer
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
- 2012-12-19
The study was a three-arm, active-control, multi-centre, parallel group study.
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
Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364
Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment
Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3
Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252
Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28
Participants Grouped by Time to Prostate-specific Antigen Failure
Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)
The Mean Value of QTc Interval as Measured by Electrocardiogram
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Main Inclusion Criteria: * Patients, aged 18 years or over, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated. * Baseline testosterone \>1.5 ng/mL. * Life expectancy of at least 12 months.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- MALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
- intervention Names
- Drug: Degarelix
- label
- degarelix 240/160 mg
- type
- EXPERIMENTAL
- description
- Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
- intervention Names
- Drug: Degarelix
- label
- degarelix 240/80 mg
- type
- EXPERIMENTAL
- description
- Leuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0.
- intervention Names
- Drug: Leuprolide 7.5 mg
- label
- Leuprolide 7.5 mg
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- degarelix 240/160 mg
- description
- Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days for 364 days.
- name
- Degarelix
- other Names
- FE200486
- type
- DRUG
- arm Group Labels
- degarelix 240/80 mg
- description
- Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days for 364 days.
- name
- Degarelix
- other Names
- FE 200486
- type
- DRUG
- arm Group Labels
- Leuprolide 7.5 mg
- description
- Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.
- name
- Leuprolide 7.5 mg
- other Names
- Lupron
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 620
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Kaplan-Maier estimates of the cumulative probabilities of testosterone \<=0.5 ng/mL from Day 28 to Day 364. The degarelix response rate estimation determined whether the lower bound of the 95% confidence interval for the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364 was no lower than 90%.
- measure
- Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364
- time Frame
- 12 months
- secondary Outcomes
- description
- A patient was defined as having a testosterone surge if the testosterone level exceeded baseline by \>=15% on any two days during the first two weeks of treatment (i.e. two of Study Days 1, 3, 7 and 14).
- measure
- Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment
- time Frame
- 2 weeks
- description
- This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.
- measure
- Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3
- time Frame
- 3 days
- description
- Testosterone increases on Day 255 and/or on Day 259 (highest value of Day 255 and Day 259 was used) were compared with Day 252 values. Patients were categorised with shifts of \<=-0.25, \>-0.25-0, \>0-0.25, \>0.25-0.5 and \>0.5 ng/mL from mean testosterone levels on Day 252.
- measure
- Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252
- time Frame
- Day 252, Day 255, and Day 259
- description
- Percentage change from Baseline to Day 14 and Day 28 in prostate-specific antigen, which is a clinically important biological marker for treatment effect and prostate cancer progression.
- measure
- Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28
- time Frame
- Days 14 and 28
- description
- The time to prostate specific antigen failure was defined as the days from first dosing (scheduled dosing days) where an increase in serum prostate specific antigen of ≥50% from nadir and a least 5 ng/mL measured on two consecutive occasions at least two weeks apart was noted.
- measure
- Participants Grouped by Time to Prostate-specific Antigen Failure
- time Frame
- 12 months
- description
- Criteria for lab values changes from baseline to the end of the study considered markedly abnormal were set for each lab test. If 20% of patients reached that value, the results were reported.
- measure
- Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)
- time Frame
- Baseline to Day 364
- description
- The QTc interval results are calculated with Fridericia's correction. QTc intervals are a standard evaluation of an electrocardiogram and help measure the risk of developing ventricular arrhythmias.
- measure
- The Mean Value of QTc Interval as Measured by Electrocardiogram
- time Frame
- 12 months
- description
- Vital signs and body weight included incidence of markedly abnormal changes from baseline to the end of the study in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of patients in each group with normal baseline and markedly abnormal value post-baseline.
- measure
- Participants With Markedly Abnormal Change in Vital Signs and Body Weight
- time Frame
- 12 months
Full study description
- brief Summary
- The study was a three-arm, active-control, multi-centre, parallel group study.
Source references
- references
- citation
- Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schroder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. doi: 10.1111/j.1464-410X.2008.08183.x.
- pmid
- 19035858
- type
- RESULT
- 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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- occurrences
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- 14 CLINICAL STUDIES The safety and efficacy of FIRMAGON were evaluated in an open-label, multi-center, randomized, parallel-group study (NCT00295750) in patients with prostate cancer. A total of 620 patients were randomized to receive one of two FIRMAGON dosing regimens or leuprolide for one year: a. FIRMAG
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Preserved source evidence · Not medical advice