Prostate CancerPhase 3NCT00242567
Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer
A Phase 3 study testing Zoledronic Acid and Androgen Deprivation Therapy (ADT) in people with Prostate Cancer, run by Novartis Pharmaceuticals at 27 sites in 10 countries.
Trial summary
This study aims to determine whether early treatment with zoledronic acid, that is given during the early phase of advanced prostate cancer, will be more efficacious than delayed treatment Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Zoledronic Acid and Androgen Deprivation Therapy (ADT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 522 participants
- Where
- 27 sitesin 10 countries
- Study dates
- Dec 2005to Jan 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- prostate cancer
- at least one bone metastasis
- receiving or about to receive androgen deprivation therapy (ADT)
Who cannot join
- previous ADT failure
- previous or current treatment with another bone-protecting agent, chemotherapy or targeted therapy
- abnormal renal function
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
27 sites in 10 countries.
27 sites in 10 countries
Australia5 sites
Novartis Investigative Site
Adelaide
Novartis Investigative Site
Brisbane
Novartis Investigative Site
Melbourne
Novartis Investigative Site
Port Macquarie
Novartis Investigative Site
Sydney
New Zealand5 sites
Novartis Investigative Site
Auckland
Novartis Investigative Site
Christchurch
Novartis Investigative Site
Hamilton
Novartis Investigative Site
Tauranga
Novartis Investigative Site
Wellington
Brazil3 sites
Novartis Investigative Site
Porto Alegre
Novartis Investigative Site
Santo André
Novartis Investigative Site
São Paulo
China3 sites
Novartis Investigative Site
Beijing
Novartis Investigative Site
Chongqing
Novartis Investigative Site
Shanghai
South Korea3 sites
Novartis Investigative Site
Busan
Novartis Investigative Site
Kyunggi-do
Novartis Investigative Site
Seoul
Taiwan3 sites
Novartis Investigative Site
Taichung
Novartis Investigative Site
Taipei
Novartis Investigative Site
Taoyuan
Thailand2 sites
Novartis Investigative Site
Bangkok
Novartis Investigative Site
Songkhla
About this study
Official title: A Phase III, Parallel Group, Randomized, Open-label, Multi-centre Clinical Trial of Zoledronic Acid in Males Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer.
This study aims to determine whether early treatment with zoledronic acid, that is given during the early phase of advanced prostate cancer, will be more efficacious than delayed treatment
- Conditions
- Prostate Cancer
- Being tested
- Zoledronic Acid, Androgen Deprivation Therapy (ADT)
- Keywords
- zoledronic acid, bone metastases, prostate cancer, hormone-sensitive
- 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
Zoledronic acid was provided by Novartis in vials containing 4 mg/5 mL liquid concentrate. Prior to administration, the liquid concentrate from one vial was to be further diluted with 100 mL of calcium-free infusion solution (0.9 % weight by volume sodium chloride solution or 5 % weight by volume glucose solution). If refrigerated, the solution had to be allowed to reach room temperature before administration.
After addition of the liquid concentrate to the infusion media, the infusion solution was to be used as soon as practicable to reduce the risk of microbiological hazard. If storage of the solution was necessary, it had to be refrigerated at temperatures between 2-8 degrees C and was to be used within 24 hours.
The infusion solution containing 4 mg zoledronic acid was to be administered every 4 weeks as an i.v. infusion over no less than 15 minutes.
Androgen Deprivation Therapy (ADT)Drug
Androgen deprivation therapy (ADT) was to be administered according to institutional protocols, in accordance with relevant prescribing information. The type and duration of androgen deprivation was at the discretion of the treating specialist, and could include orchiectomy where this would normally have been performed. Androgen deprivation therapy was provided by the investigational center, or obtained by the patient from usual sources. Anti-androgen monotherapy and intermittent ADT were excluded in the first 12 months of the study.
| Study group | Role | What they receive |
|---|---|---|
| Early Group | Experimental | Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline. Receives: Drug: Zoledronic Acid |
| Delayed group | Experimental | Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline Serum Prostate-specific Antigen (PSA) level. Receives: Drug: Androgen Deprivation Therapy (ADT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer
Skeletal-related event free survival is the time from randomization until the first detected Skeletal Related Event (SRE). Patients who were still SRE-free at 18 months were censored.
Measured: 18 months
Secondary outcomes (4)
Overall Survival at 18 Months and 3 Years
Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause.
Measured: month 18, year 3
Time to Occurrence of Skeletal Related Event or Death
Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.
Measured: 18 Months
Skeletal-related Event(SRE)-Free Survival
Time from randomization until the first detected SRE. Patients who were still SRE-free at 3 years were censored.
Measured: 36 months
Time to Occurrence of Skeletal Related Event or Death
Time from randomization to the first detected skeletal related event or death. This endpoint is the same as the primary endpoint with the modification that deaths are considered events.
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startDec 2005
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242567
- Sponsor's protocol ID
- CZOL446E2432
- Status last verified
- Apr 2014
- First submitted
- 19 Oct 2005
- Last updated
- 7 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Parallel Group, Randomized, Open-label, Multi-centre Clinical Trial of Zoledronic Acid in Males Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer.
- ClinicalTrials.gov ID
- NCT00242567
- Acronym / sponsor ID
- CZOL446E2432
- Conditions
- Prostate Cancer
- Keywords
- zoledronic acid, bone metastases, prostate cancer, hormone-sensitive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 20 Oct 2005 (estimated)
- Results
- Posted 6 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine whether early treatment with zoledronic acid, that is given during the early phase of advanced prostate cancer, will be more efficacious than delayed treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Group | Experimental | Drug: Zoledronic AcidZoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline. |
| Delayed group | Experimental | Drug: Androgen Deprivation Therapy (ADT)Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline Serum Prostate-specific Antigen (PSA) level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- prostate cancer
- at least one bone metastasis
- receiving or about to receive androgen deprivation therapy (ADT)
Key exclusion criteria (4 listed)
- previous ADT failure
- previous or current treatment with another bone-protecting agent, chemotherapy or targeted therapy
- abnormal renal function
- 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 AcidZoledronic acid was provided by Novartis in vials containing 4 mg/5 mL liquid concentrate. Prior to administration, the liquid concentrate from one vial was to be further diluted with 100 mL of calcium-free infusion solution (0.9 % weight by volume sodium chloride solution or 5 % weight by volume glucose solution). If refrigerated, the solution had to be allowed to reach room temperature before administration. After addition of the liquid concentrate to the infusion media, the infusion solution was to be used as soon as practicable to reduce the risk of microbiological hazard. If storage of the solution was necessary, it had to be refrigerated at temperatures between 2-8 degrees C and was to be used within 24 hours. The infusion solution containing 4 mg zoledronic acid was to be administered every 4 weeks as an i.v. infusion over no less than 15 minutes. | Drug | Early Group |
| Androgen Deprivation Therapy (ADT)Androgen deprivation therapy (ADT) was to be administered according to institutional protocols, in accordance with relevant prescribing information. The type and duration of androgen deprivation was at the discretion of the treating specialist, and could include orchiectomy where this would normally have been performed. Androgen deprivation therapy was provided by the investigational center, or obtained by the patient from usual sources. Anti-androgen monotherapy and intermittent ADT were excluded in the first 12 months of the study. | Drug | Delayed group |
Primary outcome
Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer
Time frame: 18 months
Skeletal-related event free survival is the time from randomization until the first detected Skeletal Related Event (SRE). Patients who were still SRE-free at 18 months were censored.
4 secondary outcomes
Overall Survival at 18 Months and 3 Years
Time frame: month 18, year 3
Time to Occurrence of Skeletal Related Event or Death
Time frame: 18 Months
Skeletal-related Event(SRE)-Free Survival
Time frame: 36 months
Time to Occurrence of Skeletal Related Event or Death
Time frame: 36 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
27 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zoledronic Acid and Androgen Deprivation Therapy (ADT) in people with Prostate Cancer, run by Novartis Pharmaceuticals at 27 sites in 10 countries.
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 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Australia, New Zealand, Brazil, China, South Korea and 5 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer (time frame: 18 months). 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 7 May 2014.