Clinical trial · Interventional
Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
An Open-Label, Multi-Centre, Randomised Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy
- 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)
The study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of treatment.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Degarelix | Drug | Degarelix | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
- interventionNames
- Drug: Degarelix
- type
- EXPERIMENTAL
- label
- B
- description
- Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
- interventionNames
- Drug: Degarelix
Primary outcomes (1)
- measure
- Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion / Exclusion Criteria: * Patients, aged 18 years or older, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated. * Screening testosterone level above the lower limit of normal range, globally defined as \>2.2 ng/mL. * Eastern Cooperative Oncology Group (ECOG) score of ≤2. * Screening prostate-specific antigen (PSA) level ≥ ng/mL.
References
Publications (0)
Data not yet available