DRUG
Degarelix
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.
Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer
Status
Completed
Phase
Phase 2 / Phase 3
Enrollment
57
Locations
22
Results
Posted
Publications
0
Study summary
What the protocol is testing.
This was an extension study for the study FE200486 CS14 (NCT00116779). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained. The study was terminated when all ongoing participants had been treated for at least 5 years.
Full detailed description
Participants who completed the main FE200486 CS14 study initially continued with the same dose in the FE200486 CS14A extension study. A protocol amendment changed the dosage to 160 mg (40 mg/mL) for all study participants. The data include data from the participants who participated in both the main study (FE200486 CS14; NCT00116779) and the extension study FE200486 CS14A.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jul 6, 2005
Study start
Mar 2005
Primary completion
Sep 2009
Study completion
Nov 2009
Results posted
Oct 21, 2010
Registry updated
Dec 18, 2025
Outcomes
What the study measures.
Primary outcomes
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Time frame · 5 years
This outcome measure included incidence of markedly abnormal changes 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 participants in each group with normal baseline and markedly abnormal value post-baseline.
Liver Function Tests
Time frame · 5 years
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- MALE
- Healthy volunteers
- No
Inclusion Criteria: * Has given written consent prior to any study-related activity being performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient. * Has completed study FE200486 CS14 through visit 22. Exclusion Criterion: * Has been withdrawn from the FE200486 CS14 study.
Study locations
22 registered sites.
Canada · United States. Showing up to 24 locations stored in the fast local snapshot.
Urology Centers of Alabama
Homewood, Alabama, United States
Advanced Urology Medical Center
Anaheim, California, United States
West Coast Clinical Research
Tarzana, California, United States
Western Clinical Research
Torrance, California, United States
Urology Associate PC'
Denver, Colorado, United States
South Florida Medical Research
Aventura, Florida, United States
SW Florida Urological Associates
Fort Myers, Florida, United States
Northeast Indiana Research, LLC
Fort Wayne, Indiana, United States
Regional Urology
Shreveport, Louisiana, United States
Lawrenceville Urology
Lawrenceville, New Jersey, United States
The Urology Center
Greensboro, North Carolina, United States
State College Urologic Association
State College, Pennsylvania, United States
University Urological Research Institute
Providence, Rhode Island, United States
Urology San Antonio Research
San Antonio, Texas, United States
University of Vermont, Dept of Surgery
South Burlington, Vermont, United States
Virginia Urology Center
Richmond, Virginia, United States
Investigational site
Seattle, Washington, United States
Can-Med Clinical Research, Inc.
Victoria, British Columbia, Canada
The Male and Female Health and Research Centers
Barrie, Ontario, Canada
Brantford Urology Research
Brantford, Ontario, Canada
Burlington Professional Care
Burlington, Ontario, Canada
The Female/Male Health Centres
Oakville, Ontario, Canada
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Degarelix.
NCT IDStudyPhase / statusEnrollmentUpdated
Androgen Deprivation Therapy Prior to Prostatectomy for Patients With Intermediate and High Risk Prostate Cancer
Memorial Sloan Kettering Cancer Center · Prostate Cancer · Prostatic Adenocarcinoma
Not applicable
Completed
41
2026-07
NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
Novartis · Metastatic Neuroendocrine Prostate Cancer
Phase 1
Active, not recruiting
31
2026-07
Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial
Mayo Clinic · Recurrent Castration-Sensitive Prostate Carcinoma · Recurrent Prostate Cancer
Phase 2
Recruiting
532
2026-07
NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial
M.D. Anderson Cancer Center · Prostate Cancer
Phase 1 / Phase 2
Recruiting
6
2026-07
Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)
NYU Langone Health · Intraprostatic Prostate Cancer
Not applicable
Recruiting
28
2026-07
Combining Ipilimumab, Degarelix, and Radical Prostatectomy in Men With Newly Diagnosed Metastatic Castration Sensitive Prostate Cancer or Ipilimumab and Degarelix in Men With Biochemically Recurrent Castration Sensitive Prostate Cancer After Radical Prostatectomy
Memorial Sloan Kettering Cancer Center · Metastatic Castration Sensitive Prostate Cancer
Phase 2
Completed
16
2026-07
High-Dose Brachytherapy in Treating Patients With Prostate Cancer
Stanford University · Prostate Adenocarcinoma · Stage I Prostate Cancer
Not applicable
Completed
146
2026-07
Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer
University of Wisconsin, Madison · Prostate Cancer
Phase 1 / Phase 2
Active, not recruiting
57
2026-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.