Clinical trial · Interventional
Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer
A Phase III, Parallel Group, Randomized, Open-label, Multi-centre Clinical Trial of Zoledronic Acid in Males Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer.
NCT00242567CI-TRIAL-00014441completedPhase 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)
This study aims to determine whether early treatment with zoledronic acid, that is given during the early phase of advanced prostate cancer, will be more efficacious than delayed 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen Deprivation Therapy (ADT) | Drug | — | UNRESOLVED |
| Zoledronic Acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Early Group
- description
- Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
- interventionNames
- Drug: Zoledronic Acid
- type
- EXPERIMENTAL
- label
- Delayed group
- description
- Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline Serum Prostate-specific Antigen (PSA) level.
- interventionNames
- Drug: Androgen Deprivation Therapy (ADT)
Primary outcomes (1)
- measure
- Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * prostate cancer * at least one bone metastasis * receiving or about to receive androgen deprivation therapy (ADT) Exclusion Criteria: * previous ADT failure * previous or current treatment with another bone-protecting agent, chemotherapy or targeted therapy * abnormal renal function Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.