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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, molecular staging, antitumor potential

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria Prostate cancer Radical prostatectomy or external beam irradiation therapy within 6 months before study entry. No bone metastases according to bone scan Exclusion Criteria Metastatic prostate cancer Hormone ablation therapy for more than 3 months before/after radical prostatectomy and external beam irradiation therapy Treatment with bisphosphonates or other drugs known to affect the skeleton within the past year. Other protocol-defined inclusion / exclusion criteria may apply.

Sites / Locations

  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zoledronic acid

Arm Description

4 mg IV infused over 15 minutes every 3 months

Outcomes

Primary Outcome Measures

To assess the activity of one year treatment with zoledronic acid

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
May 28, 2017
Sponsor
Novartis Pharmaceuticals
Collaborators
University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT00219271
Brief Title
Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer
Official Title
Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
University of Athens

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, molecular staging, antitumor potential

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zoledronic acid
Arm Type
Experimental
Arm Description
4 mg IV infused over 15 minutes every 3 months
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Primary Outcome Measure Information:
Title
To assess the activity of one year treatment with zoledronic acid
Time Frame
12 mos
Secondary Outcome Measure Information:
Title
Three-year disease free survival
Time Frame
3 years
Title
Change in bone mineral density at 12, 24 and 36 months versus baseline
Time Frame
12, 24 and 36 months
Title
Changes in bone resorption markers at 12, 24 and 36 months versus baseline
Time Frame
12, 24 and 36 months
Title
Safety and tolerability through abnormal values and AE reporting
Time Frame
upto 36 mos

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Prostate cancer Radical prostatectomy or external beam irradiation therapy within 6 months before study entry. No bone metastases according to bone scan Exclusion Criteria Metastatic prostate cancer Hormone ablation therapy for more than 3 months before/after radical prostatectomy and external beam irradiation therapy Treatment with bisphosphonates or other drugs known to affect the skeleton within the past year. Other protocol-defined inclusion / exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Athens
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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