The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer
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
1 other identifier
interventional
620
12 countries
35
Brief Summary
The study was a three-arm, active-control, multi-centre, parallel group study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 prostate-cancer
Started Feb 2006
Shorter than P25 for phase_3 prostate-cancer
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 22, 2006
CompletedFirst Posted
Study publicly available on registry
February 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedResults Posted
Study results publicly available
April 16, 2009
CompletedDecember 19, 2012
December 1, 2012
1.7 years
February 22, 2006
January 5, 2009
December 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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%.
12 months
Secondary Outcomes (8)
Percentage of Patients With Testosterone Surge During the First Two Weeks of Treatment
2 weeks
Percentage of Patients With Testosterone Level <=0.5 ng/mL at Day 3
3 days
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
Percentage Change in Prostate-specific Antigen From Baseline to Day 14 and Day 28
Days 14 and 28
Participants Grouped by Time to Prostate-specific Antigen Failure
12 months
- +3 more secondary outcomes
Study Arms (3)
degarelix 240/160 mg
EXPERIMENTALInitial 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.
degarelix 240/80 mg
EXPERIMENTALInitial 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.
Leuprolide 7.5 mg
ACTIVE COMPARATORLeuprolide (Lupron Depot) 7.5 mg IM (in the muscle) every 28 days starting at day 0.
Interventions
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.
Leuprolide (Lupron Depot) 7.5mg IM (in the muscle every 28 days starting at day 0.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
Alaska Clinical Research Center, LLC
Anchorage, Alaska, 99508, United States
Advanced Urology Medical Center
Anaheim, California, 92801, United States
Pacific Clinical Center
Beverly Hills, California, 90210, United States
Simi-San Faernando Valley Urology Associates
Granada Hills, California, 91344, United States
South Orange County Medical Research Center
Laguna Woods, California, 92653, United States
Western Clinical Research
Torrance, California, 90505, United States
Urology Associate PC
Denver, Colorado, 80210, United States
University of Colorado
Denver, Colorado, 80262, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Florida Foundation for Healthcare Research
Ocala, Florida, 34474, United States
Regional Urology
Shreveport, Louisiana, 71106, United States
Lawrenceville Urology
Lawrenceville, New Jersey, 08648, United States
Jay A. Motola, MD, FACS
Carmel, New York, 10512, United States
Northeast Urology Research
Concord, North Carolina, 28025, United States
The Urology Center
Greensboro, North Carolina, 27401, United States
State College Urologic Association
State College, Pennsylvania, 16801, United States
Univeristy Urological Research Institute
Providence, Rhode Island, 02904, United States
University Urological Research Institute
Providence, Rhode Island, 02904, United States
Grand Strand Urology
Myrtle Beach, South Carolina, 29572, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
Urology of Virginia Research
Norfolk, Virginia, 23502, United States
Office of Jeffrey Frankel
Seattle, Washington, 98166, United States
Bruce W. Palmer Urology Inc, 125-70 Exhibition Street
Kentville, Nova Scotia, B4N 4KB, Canada
Nemocnice Jindrichuv Hradec a.s., U Nemocnice 380/III
Jindřichův Hradec, 37738, Czechia
Urologische Klinik, Universitatsklinikum Mannheim, Theodor-Kutzer-Ufer 1-3
Mannheim, 68167, Germany
Szeged M.J.V.O. Korhaza, Urologiai Osztaly, Kalvaria sugarut 57
Szeged, H-6725, Hungary
Hospital General "Dr Santiago Ramon y Cajal", ISSSTE
Predio Canoas S/N, Durango, DGO, 34079, Mexico
Atrium MC, Henri Dunantstraat 5
Heerlen, 6419 PC, Netherlands
Cristo Redentor Hospital
La Hacienda, 00784, Puerto Rico
San Juan VA Medical Center
San Juan, 00921, Puerto Rico
Provita Center, 2 Primaverii Street
Constanța, 900635, Romania
Andros Urology Clinic, Ulitsa Lenina 36A
Saint Petersburg, 197136, Russia
Kiev City Clinical Hospital #3, Petr Ivaschenko 26, Petra Zaporogtsa str.
Kiev, 2125, Ukraine
Derriford Hospital, Derriford Road
Plymouth, PL6 8DH, United Kingdom
Related Publications (2)
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: 19035858RESULTZengerling 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: 34350976DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ferring Pharmaceuticals
- Organization
- Clinical Development Support
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2006
First Posted
February 24, 2006
Study Start
February 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
December 19, 2012
Results First Posted
April 16, 2009
Record last verified: 2012-12