Clinical trial · Interventional
A Trial of Degarelix in Patients With Prostate Cancer
An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen With Goserelin Acetate in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
NCT00946920CI-TRIAL-00014758completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Degarelix 240 mg/480 mg
- interventionNames
- Drug: Degarelix
- type
- ACTIVE_COMPARATOR
- label
- Goserelin acetate
- interventionNames
- Drug: Goserelin acetate
Primary outcomes (2)
- measure
- Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix
- timeFrame
- From Day 28 to Day 364
- description
- This co-primary outcome measure was used to demonstrate that degarelix is effective with respect to achieving and maintaining testosterone suppression to castrate levels, evaluated as the proportion of patients with testosterone suppression ≤0.5 ng/mL from Day 28 to Day 364.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older. * Has a histological confirmed prostate cancer Gleason graded). * Has a screening testosterone above 2.2 ng/mL. * Rising prostate-specific antigen (PSA). * Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2. * Has a life expectancy of at least one year. Exclusion Criteria: * Current or previous hormone therapy. * Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening. * Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema. * Has a heart insufficiency. * Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years. * Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator. * Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial. * Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
References
Publications (1)
- DERIVEDZengerling 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 34350976