Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Androgen Deprivation Therapy (ADT); Drug: Zoledronic Acid

• Registration Number: NCT00242567
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-10-19
• Study First Submitted QC: 2005-10-19
• Study First Posted: 2005-10-20
• Study Start: 2005-12
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2013-01-29
• Results First Submitted QC: 2013-01-29
• Results First Posted: 2013-03-06
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-14
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 522

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed group	Androgen Deprivation Therapy (ADT)	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.
Early Group	Zoledronic Acid	Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.

Primary Outcome Measures

Name	Time	Method
Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer	18 months	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.

Secondary Outcome Measures

Name	Time	Method
Time to Occurrence of Skeletal Related Event or Death	36 Months	Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.
Skeletal-related Event(SRE)-Free Survival	36 months	Time from randomization until the first detected SRE. Patients who were still SRE-free at 3 years were censored.
Overall Survival at 18 Months and 3 Years	month 18, year 3	Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇹🇭 Songkhla, Thailand