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

NCT ID: NCT00219271

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2009-09-30

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zoledronic acid

4 mg IV infused over 15 minutes every 3 months

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

Interventions

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Zoledronic acid

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Athens

OTHER

Sponsor Role collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Athens, , Greece

Site Status

Countries

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Greece

Other Identifiers

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CZOL446GGR01

Identifier Type: -

Identifier Source: org_study_id

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