Prostate Cancer With Bone MetastasisPhase 4NCT00241111
Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis
A Phase 4 study testing zoledronic acid in people with Prostate Cancer With Bone Metastasis, run by Novartis Pharmaceuticals.
Trial summary
Study to determine effectiveness and safety of zoledronic acid and whether it has a pharmaco-economic impact in prostate cancer with bone metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer With Bone Metastasis
- What is being tested?
- zoledronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Jan 2006
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years.
- Written informed consent.
- With histologically-proven prostate carcinoma.
- ECOG performance status ≤ 2
- Life expectancy > 12 months
- Current or previously documented diagnosis of at least 1 bone metastasis due to prostate cancer (patient could be hormono naif, Hormono sensible or hormono refractory)
- Patients with partners of childbearing potential should use a barrier method of contraception throughout the study.
Who cannot join
- ECOG performans status >3
- Prior treatment with bisphosphonates IV within the last 3 month to the study
- Renal insufficiency (serum creatinine > 265 micromol/L or > 3.0 mg/dL)
- Liver function tests > 2.5 ULN
- Patients with another nonmalignant disease which would confuse the evaluation of primary endpoints or prevent the patient from complying with the protocol.
- History of concomitant disease with influence on bone metabolism such as Paget's disease or primary hyperparathyroidism
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- Disabling or non controlled concomitant disease likely to alter the quality of life
- Patient unable to fill in a questionnaire: senile dementia, psychiatric or neurological disease, illiterate or partially sighted patient
- Known hypersensitivity to zoledronic acid or other bisphosphonates
- Other protocol-defined inclusion / exclusion criteria may apply.
About this study
Study to determine effectiveness and safety of zoledronic acid and whether it has a pharmaco-economic impact in prostate cancer with bone metastasis.
- Conditions
- Prostate Cancer With Bone Metastasis
- Being tested
- zoledronic acid
- Keywords
- Prostate, cancer, bone metastasis, zoledronic acid
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
Also called ZOl446
| Study group | Role | What they receive |
|---|---|---|
| Zometa | Other | Not described Receives: Drug: zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess the effectiveness of Zol in prevention of SREs in stratified groups (hormonal treatment)
Measured: at 15 months & at end of study
Secondary outcomes (4)
to assess the effectiveness of Zol in improving pain and QoL in prostate cancer patients with bone metastases
Measured: V1, V2, V3, V5
to assess the safety of ZOL treatment
Measured: V1, V2, V3, V5
to assess resources consumption
Measured: V1, V2, V3, V5
to assess BM
Measured: V1 et V5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startSep 2003
- Primary completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer With Bone MetastasisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241111
- Sponsor's protocol ID
- CZOL446EFR04
- Status last verified
- Apr 2010
- First submitted
- 14 Oct 2005
- Last updated
- 6 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis
- ClinicalTrials.gov ID
- NCT00241111
- Acronym / sponsor ID
- CZOL446EFR04
- Conditions
- Prostate Cancer With Bone Metastasis
- Keywords
- Prostate, cancer, bone metastasis, zoledronic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Jan 2006 (actual)
- First posted
- 18 Oct 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.
Study to determine effectiveness and safety of zoledronic acid and whether it has a pharmaco-economic impact in prostate cancer with bone metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zometa | Other | Drug: zoledronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥18 years.
- Written informed consent.
- With histologically-proven prostate carcinoma.
- ECOG performance status ≤ 2
- Life expectancy > 12 months
Key exclusion criteria (10 listed)
- ECOG performans status >3
- Prior treatment with bisphosphonates IV within the last 3 month to the study
- Renal insufficiency (serum creatinine > 265 micromol/L or > 3.0 mg/dL)
- Liver function tests > 2.5 ULN
- Patients with another nonmalignant disease which would confuse the evaluation of primary endpoints or prevent the patient from complying with the protocol.
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 acidAlso: ZOl446 | Drug | Zometa |
Primary outcome
to assess the effectiveness of Zol in prevention of SREs in stratified groups (hormonal treatment)
Time frame: at 15 months & at end of study
4 secondary outcomes
to assess the effectiveness of Zol in improving pain and QoL in prostate cancer patients with bone metastases
Time frame: V1, V2, V3, V5
to assess the safety of ZOL treatment
Time frame: V1, V2, V3, V5
to assess resources consumption
Time frame: V1, V2, V3, V5
to assess BM
Time frame: V1 et V5
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 6 Mar 2017.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing zoledronic acid in people with Prostate Cancer With Bone Metastasis, run by Novartis Pharmaceuticals.
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 7 inclusion and 10 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 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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 effectiveness of Zol in prevention of SREs in stratified groups (hormonal treatment) (time frame: at 15 months & at end of study). 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 6 Mar 2017.