Prostate CancerPhase 4NCT00219271
Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer
A Phase 4 study testing Zoledronic acid in people with Prostate Cancer, run by Novartis Pharmaceuticals at 1 site in Greece.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2003to Sep 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate cancer
- Radical prostatectomy or external beam irradiation therapy within 6 months before study entry.
- No bone metastases according to bone scan
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Prostate Cancer
- Being tested
- Zoledronic acid
- Keywords
- Prostate cancer, molecular staging, antitumor potential
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic acid | Experimental | 4 mg IV infused over 15 minutes every 3 months Receives: Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the activity of one year treatment with zoledronic acid
Measured: 12 mos
Secondary outcomes (4)
Three-year disease free survival
Measured: 3 years
Change in bone mineral density at 12, 24 and 36 months versus baseline
Measured: 12, 24 and 36 months
Changes in bone resorption markers at 12, 24 and 36 months versus baseline
Measured: 12, 24 and 36 months
Safety and tolerability through abnormal values and AE reporting
Measured: upto 36 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Athens
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219271
- Sponsor's protocol ID
- CZOL446GGR01
- Status last verified
- May 2017
- First submitted
- 13 Sep 2005
- Last updated
- 31 May 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00219271
- Acronym / sponsor ID
- CZOL446GGR01
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, molecular staging, antitumor potential
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- University of Athens
- Study start
- Sep 2003
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zoledronic acid | Experimental | Drug: Zoledronic acid4 mg IV infused over 15 minutes every 3 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prostate cancer
- Radical prostatectomy or external beam irradiation therapy within 6 months before study entry.
- No bone metastases according to bone scan
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic acid | Drug | Zoledronic acid |
Primary outcome
To assess the activity of one year treatment with zoledronic acid
Time frame: 12 mos
4 secondary outcomes
Three-year disease free survival
Time frame: 3 years
Change in bone mineral density at 12, 24 and 36 months versus baseline
Time frame: 12, 24 and 36 months
Changes in bone resorption markers at 12, 24 and 36 months versus baseline
Time frame: 12, 24 and 36 months
Safety and tolerability through abnormal values and AE reporting
Time frame: upto 36 mos
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zoledronic acid in people with Prostate Cancer, run by Novartis Pharmaceuticals at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the activity of one year treatment with zoledronic acid (time frame: 12 mos). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.