The study was a three-arm, active-control, multi-centre, parallel group study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
620
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.
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.
Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.
Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364
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%.
Time frame: 12 months
Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment
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).
Time frame: 2 weeks
Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3
This outcome measure presents the testosterone levels 3 days after the initial dose of trial medication.
Time frame: 3 days
Frequency and Size of Testosterone Changes at Day 255 and/or Day 259 Compared to the Testosterone Level at Day 252
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.
Time frame: Day 252, Day 255, and Day 259
Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 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.
Time frame: Days 14 and 28
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Urology Centers of Alabama
Homewood, Alabama, United States
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States
Advanced Urology Medical Center
Anaheim, California, United States
Pacific Clinical Center
Beverly Hills, California, United States
Simi-San Faernando Valley Urology Associates
Granada Hills, California, United States
South Orange County Medical Research Center
Laguna Woods, California, United States
Western Clinical Research
Torrance, California, United States
Urology Associate PC
Denver, Colorado, United States
University of Colorado
Denver, Colorado, United States
South Florida Medical Research
Aventura, Florida, United States
...and 25 more locations
Participants Grouped by Time to Prostate-specific Antigen Failure
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.
Time frame: 12 months
Participants With Markedly Abnormal Change in Laboratory Variables (>=20 Percent of Patients)
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.
Time frame: Baseline to Day 364
The Mean Value of QTc Interval as Measured by Electrocardiogram
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.
Time frame: 12 months
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
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.
Time frame: 12 months