Phase 3
N=522
Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00242567 ↗Enrolled (actual)
522
Serious AEs
41.9%
Results posted
Mar 2013
Primary outcome: Primary: Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer — 58; 49; 201; 214 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zoledronic Acid (Drug); Androgen Deprivation Therapy (ADT) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer |
58; 49; 201; 214 | — |
| SECONDARY Overall Survival at 18 Months and 3 Years |
31; 21; 228; 242; 49; 44 | — |
| SECONDARY Time to Occurrence of Skeletal Related Event or Death |
NA; NA | — |
| SECONDARY Skeletal-related Event(SRE)-Free Survival |
NA; NA | — |
| SECONDARY Time to Occurrence of Skeletal Related Event or Death |
NA; NA | — |
Summary
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00242567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.