The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00295750|
Recruitment Status : Completed
First Posted : February 24, 2006
Results First Posted : April 16, 2009
Last Update Posted : December 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Degarelix Drug: Leuprolide 7.5 mg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||620 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multi-Centre, Randomized, Parallel-group Study, Investigating the Efficacy and Safety of Degarelix One Month Dosing Regimens; 160 mg (40 mg/ml) and 80 mg (20mg/ml), in Comparison to LUPRON DEPOT® 7.5 mg in Patients With Prostate Cancer Requiring Androgen Ablation Therapy|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
Experimental: degarelix 240/160 mg
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.
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.
Other Name: FE200486
Experimental: degarelix 240/80 mg
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.
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.
Other Name: FE 200486
Active Comparator: Leuprolide 7.5 mg
Leuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0.
Drug: Leuprolide 7.5 mg
Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.
Other Name: Lupron
- Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364 [ Time Frame: 12 months ]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%.
- Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment [ Time Frame: 2 weeks ]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).
- Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3 [ Time Frame: 3 days ]This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.
- 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 ]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.
- Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28 [ Time Frame: Days 14 and 28 ]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.
- Participants Grouped by Time to Prostate-specific Antigen Failure [ Time Frame: 12 months ]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.
- Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients) [ Time Frame: Baseline to Day 364 ]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.
- The Mean Value of QTc Interval as Measured by Electrocardiogram [ Time Frame: 12 months ]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.
- Participants With Markedly Abnormal Change in Vital Signs and Body Weight [ Time Frame: 12 months ]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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295750
|Study Director:||Clinical Development Support||Ferring Pharmaceuticals|