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

Novartis

Status and phase: Completed; Phase 4

Conditions: Prostate Cancer

Treatments: Drug: Zoledronic acid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00219271

CZOL446GGR01

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Zoledronic acid

Experimental group

Description:

4 mg IV infused over 15 minutes every 3 months

Treatment:

Drug: Zoledronic acid