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.
18 Years
N/A
Male
Prostate Cancer
Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer
Outcome Description:
Skeletal-related event free survival is the time from randomization until the first detected Skeletal Related Event (SRE). Patients who were still SRE-free at 18 months were censored.
Outcome Time Frame:
18 months
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Australia: National Health and Medical Research Council
Study ID:
CZOL446E2432
NCT ID:
NCT00242567
Start Date:
October 2005
Completion Date:
January 2012
Related Keywords:
- Prostate Cancer
- zoledronic acid
- bone metastases
- prostate cancer
- hormone-sensitive
- Prostatic Neoplasms
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