Clinical trial · Interventional
Open-Label, Randomised Parallel-Group Study
The Rationale of the Study is to Demonstrate That Degarelix Given at Three-month Dosing Intervals Will Produce and Maintain Androgen Deprivation in Prostate Cancer Patients Through Immediate and Prolonged Testosterone Suppression, and to Provide Confirmatory Evidence of the Safety of Degarelix.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to awaiting data from Phase II study.
Summary
Brief summary (as posted)
An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Ablation Therapy.
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
- 1
- description
- * Starting dose of 240 mg (40 mg/mL) will be given on Day 0. * Maintenance doses of 360 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months
- interventionNames
- Drug: Degarelix
- type
- EXPERIMENTAL
- label
- 2
- description
- * Starting dose of 240 mg (40 mg/mL) will be given on Day 0. * Maintenance doses of 480 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months.
- interventionNames
- Drug: Degarelix
Primary outcomes (1)
- measure
- To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients, aged 18 years or older, with a 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. * Screening PSA level of =2 ng/mL. ECOG score of =2. * Life expectancy of at least one year. CRITERIA FOR EVALUATION: Primary endpoint: * Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day 364. Secondary endpoints: * Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day 364. * Serum levels of testosterone, LH, FSH, and PSA over time. * Time to PSA failure - defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir. * Plasma levels of degarelix over time. * Frequency and severity of adverse events. * Clinically significant changes in laboratory safety parameters. * Clinically significant changes in physical examinations, ECGs, vital signs, and body weight.
References
Publications (0)
Data not yet available