Clinical trial · Interventional
A Study of Degarelix in Taiwanese Patients With Prostate Cancer
An Open-label, Multi-centre Registration Trial, Investigating Efficacy and Safety of Degarelix One-month Dosing Regimen in Taiwanese Patients With Prostate Cancer Requiring Androgen Ablation Therapy
NCT01220869CI-TRIAL-00088510completedPhase 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 III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Degarelix | Drug | Degarelix | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Degarelix
- interventionNames
- Drug: Degarelix
Primary outcomes (1)
- measure
- Cumulative Probability of Participants With Testosterone at Castrate Level <= 0.5 ng/mL From Day 28 to Day 168
- timeFrame
- From Day 28 to Day 168
- description
- Kaplan-Meier estimates of the cumulative probability of testosterone levels below castrate level (\<= 0.5 ng/mL) from Day 28 to Day 168 and the associated two-sided 95% confidence interval (CI) was based on log-log transformation, Greenwood's formula, and asymptotic maximum likelihood theory. The primary objective was met if the lower limit of this two-sided 95% CI was ≥90%. The definition of the primary endpoint was the Day 28 to Day 168 cumulative probability of testosterone levels below castrate levels (≤0.5 ng/mL). Only patients with a testosterone value on Day 28 and after were included in this analysis. Patients who did not experience a testosterone suppression (≤0.5 ng/mL) were censored at the time of last available testosterone measurement. The full analysis set (FAS) results were considered primary, whereas the corresponding per protocol (PP) analysis served as the sensitivity analysis.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * 20 years or older * Has a histological confirmed prostate cancer * Has a screening serum testosterone above 1.5 ng/mL * Has a Eastern Cooperative Oncology Group (ECOG) score of ≤ 2 * Has a screening PSA value of ≥2 ng/mL * Has a life expectancy of at least 168 days Exclusion Criteria: * Current or previous hormone therapy * Is currently treated with 5-α-reductase inhibitor * Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema * Is considered to be a candidate for curative therapy, i.e radical prostatectomy or radiotherapy * Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin. * Has a clinically significant disorder (other than prostate cancer) or any other condition , including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the trial as judged by the investigator * Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial
References
Publications (0)
Data not yet available
No reference posted for this study.