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

May 28, 2017 updated by: Novartis Pharmaceuticals
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zoledronic acid
4 mg IV infused over 15 minutes every 3 months
Drug: Zoledronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the activity of one year treatment with zoledronic acid
Time Frame: 12 mos
12 mos

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Collaborators

University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 28, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446GGR01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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