NCT00219271

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 prostate-cancer

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_4 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

6 years

First QC Date

September 13, 2005

Last Update Submit

May 28, 2017

Conditions

Prostate Cancer

Keywords

Prostate cancermolecular stagingantitumor potential

Outcome Measures

Primary Outcomes (1)

  • To assess the activity of one year treatment with zoledronic acid

    12 mos

Secondary Outcomes (4)

  • Three-year disease free survival

    3 years

  • Change in bone mineral density at 12, 24 and 36 months versus baseline

    12, 24 and 36 months

  • Changes in bone resorption markers at 12, 24 and 36 months versus baseline

    12, 24 and 36 months

  • Safety and tolerability through abnormal values and AE reporting

    upto 36 mos

Study Arms (1)

Zoledronic acid

EXPERIMENTAL

4 mg IV infused over 15 minutes every 3 months

Drug: Zoledronic acid

Interventions

Zoledronic acidDRUG
Zoledronic acid

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prostate cancer
  • Radical prostatectomy or external beam irradiation therapy within 6 months before study entry.
  • No bone metastases according to bone scan

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Athens, Greece

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

September 1, 2003

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)