Clinical trial · Interventional
Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer
Phase III Study of the Comparison of Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer. A One Year Randomised, Open Label, Multi-Centre Phase III Trial.
NCT00841113CI-TRIAL-00002041completedPhase 3ClinicalTrials.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)
To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic 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)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abarelix | Drug | — | UNRESOLVED |
| Goserelin plus Bicalutamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1 Abarelix
- description
- Investigative drug
- interventionNames
- Drug: Abarelix
- type
- ACTIVE_COMPARATOR
- label
- 2 Goserelin plus bicalutamide
- description
- Standard therapy
- interventionNames
- Drug: Goserelin plus Bicalutamide
Primary outcomes (1)
- measure
- Early castration rates
- timeFrame
- One week
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven prostate cancer and not previously treated with hormones * Evidance of advanced disease or metastases * Life expentancy of at least 3 months * Normal serum testosterone levels * Written informed consent Exclusion Criteria: * Previous endocrine or cytoxic theapy for prostate cancer * Known tumour complication of prostate cancer which owuld require immediate treatment * Another malignancy other than basal cell cancer * History of significant drug hypersensitivity to either LHRH agonists or GnRH antagonists. * Congenital or acquired coagulation disorders contraindicating intramuscular injections * Pagets disease of the bone * QTcB \> 450 msec at Day - 14
References
Publications (0)
Data not yet available
No reference posted for this study.