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


Phase 4
18 Years
80 Years
Not Enrolling
Male
Prostate Cancer

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the activity of one year treatment with zoledronic acid

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Greece: National Organization of Medicines

Study ID:

CZOL446GGR01

NCT ID:

NCT00219271

Start Date:

September 2003

Completion Date:

September 2009

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • molecular staging
  • antitumor potential
  • Prostatic Neoplasms

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