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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219271
• Other study ID #: CZOL446GGR01
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: May 28, 2017
• Start date: September 2003
• Est. completion date: September 2009

Study information

• Verified date: May 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Zoledronic acid

Locations

Country	Name	City	State
Greece	Novartis Investigative Site	Athens

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the activity of one year treatment with zoledronic acid		12 mos
Secondary	Three-year disease free survival		3 years
Secondary	Change in bone mineral density at 12, 24 and 36 months versus baseline		12, 24 and 36 months
Secondary	Changes in bone resorption markers at 12, 24 and 36 months versus baseline		12, 24 and 36 months
Secondary	Safety and tolerability through abnormal values and AE reporting		upto 36 mos

External Links

•   See results at Novartis Clinical Trial Tresults Database