The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer
- Registration Number
- NCT00295750
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
The study was a three-arm, active-control, multi-centre, parallel group study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 620
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Leuprolide 7.5 mg Leuprolide 7.5 mg Leuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0. degarelix 240/80 mg Degarelix 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. degarelix 240/160 mg Degarelix 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.
- Primary Outcome Measures
Name Time Method Percentage of Patients With Testosterone <=0.5ng/mL From Day 28 Through Day 364 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%.
- Secondary Outcome Measures
Name Time Method Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment 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 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 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 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 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) 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 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 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.
Trial Locations
- Locations (35)
Office of Jeffrey Frankel
🇺🇸Seattle, Washington, United States
Western Clinical Research
🇺🇸Torrance, California, United States
Regional Urology
🇺🇸Shreveport, Louisiana, United States
State College Urologic Association
🇺🇸State College, Pennsylvania, United States
Urology Associate PC
🇺🇸Denver, Colorado, United States
University of Colorado
🇺🇸Denver, Colorado, United States
Urologische Klinik, Universitatsklinikum Mannheim, Theodor-Kutzer-Ufer 1-3
🇩🇪Mannheim, Germany
San Juan VA Medical Center
🇵🇷San Juan, Puerto Rico
Grand Strand Urology
🇺🇸Myrtle Beach, South Carolina, United States
Bruce W. Palmer Urology Inc, 125-70 Exhibition Street
🇨🇦Kentville, Nova Scotia, Canada
Hospital General "Dr Santiago Ramon y Cajal", ISSSTE
🇲🇽Predio Canoas S/N, Durango, DGO, Mexico
Kiev City Clinical Hospital #3, Petr Ivaschenko 26, Petra Zaporogtsa str.
🇺🇦Kiev, Ukraine
Nemocnice Jindrichuv Hradec a.s., U Nemocnice 380/III
🇨🇿Jindrichuv Hradec, Czech Republic
Alaska Clinical Research Center, LLC
🇺🇸Anchorage, Alaska, United States
Szeged M.J.V.O. Korhaza, Urologiai Osztaly, Kalvaria sugarut 57
ðŸ‡ðŸ‡ºSzeged, Hungary
Cristo Redentor Hospital
🇵🇷La Hacienda, Puerto Rico
Provita Center, 2 Primaverii Street
🇷🇴Constanta, Romania
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Derriford Hospital, Derriford Road
🇬🇧Plymouth, United Kingdom
Simi-San Faernando Valley Urology Associates
🇺🇸Granada Hills, California, United States
Advanced Urology Medical Center
🇺🇸Anaheim, California, United States
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
Pacific Clinical Center
🇺🇸Beverly Hills, California, United States
South Orange County Medical Research Center
🇺🇸Laguna Woods,, California, United States
Florida Foundation for Healthcare Research
🇺🇸Ocala, Florida, United States
Lawrenceville Urology
🇺🇸Lawrenceville, New Jersey, United States
Northeast Urology Research
🇺🇸Concord, North Carolina, United States
Jay A. Motola, MD, FACS
🇺🇸Carmel, New York, United States
Univeristy Urological Research Institute
🇺🇸Providence, Rhode Island, United States
The Urology Center
🇺🇸Greensboro, North Carolina, United States
University Urological Research Institute
🇺🇸Providence, Rhode Island, United States
Urology San Antonio Research
🇺🇸San Antonio, Texas, United States
Urology of Virginia Research
🇺🇸Norfolk, Virginia, United States
Atrium MC, Henri Dunantstraat 5
🇳🇱Heerlen, Netherlands
Andros Urology Clinic, Ulitsa Lenina 36A
🇷🇺St Petersburg, Russian Federation