Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer

Phase 4

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Zoledronic acid

• Registration Number: NCT00219271
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The objective of this study is to assess the effect Of zoledronic acid on circulating and bone marrow-residing prostate cancer cells in patients with clinically localized prostate cancer

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-22
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-28
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zoledronic acid	Zoledronic acid	4 mg IV infused over 15 minutes every 3 months

Primary Outcome Measures

Name	Time	Method
To assess the activity of one year treatment with zoledronic acid	12 mos

Secondary Outcome Measures

Name	Time	Method
Three-year disease free survival	3 years
Change in bone mineral density at 12, 24 and 36 months versus baseline	12, 24 and 36 months
Changes in bone resorption markers at 12, 24 and 36 months versus baseline	12, 24 and 36 months
Safety and tolerability through abnormal values and AE reporting	upto 36 mos

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇷 Athens, Greece