Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients with Prostate Cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Urology Centers of Alabama
Homewood, Alabama, United States
South Orange County Urology Research
Laguna Hills, California, United States
San Bernadino Urological Association
Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax)
Time frame: Day 0-28 and at Day 112-140
Trough plasma levels (blood sample analysis)
Actual levels prior to dosing
Time frame: Day 28, 56, 84, 112, 140, 168 and 196
Proportion of patients with testosterone ≤0.5 ng/mL
Time frame: From baseline to Day 196
Serum levels of testosterone and PSA
Time frame: From baseline to Day 196
Percentage change in PSA levels
Time frame: From baseline to Day 196
Changes in patient-reported injection site pain (VAS scores over time)
Will compare starting dose to maintenance doses
Time frame: At 5 minutes and at 60 minutes after each injection
Proportion of patients without clinically significant pain (VAS score of ≤10 mm)
Time frame: 60 minutes after each dosing injection
Incidence and severity of investigator-evaluated injection site reactions
Time frame: From baseline to Day 196
Cumulative probabilities of suppressing testosterone to castrate level (≤0.5 ng/mL) by visit
Time frame: From Day 28 onwards (up to Day 196)
Predictive one-year suppression rate and 95% CI: The cumulative probability of suppressing testosterone to castrate levels (≤0.5 ng/mL)
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San Bernadino, California, United States
South Florida Medical Research
Aventura, Florida, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
Carolina Clinical Trials
Concord, North Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Clinic of North Texas
Dallas, Texas, United States
Urology San Antonio Research, Pa
San Antonio, Texas, United States
Pacific Urologic Research
Victoria, British Columbia, Canada
...and 5 more locations
Time frame: From Day 28 to Day 364
Incidence of adverse events (AEs) examined by frequency, severity, seriousness and discontinuation from study due to AEs
Time frame: From baseline to Day 196
Clinically significant changes in laboratory values
Time frame: From baseline to Day 196
Clinically significant changes in ECGs, vital signs, physical examinations, and body weight
Time frame: From baseline to Day 196