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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00242567




Registration number
NCT00242567
Ethics application status
Date submitted
19/10/2005
Date registered
20/10/2005
Date last updated
7/05/2014

Titles & IDs
Public title
Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer
Scientific 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.
Secondary ID [1] 0 0
CZOL446E2432
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zoledronic Acid
Treatment: Drugs - Androgen Deprivation Therapy (ADT)

Experimental: Early Group - Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.

Experimental: Delayed group - 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.


Treatment: Drugs: Zoledronic Acid
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.

Treatment: Drugs: 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
month 18, year 3
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
18 Months
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
36 Months

Eligibility
Key inclusion criteria
- prostate cancer

- at least one bone metastasis

- receiving or about to receive androgen deprivation therapy (ADT)
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [2] 0 0
Novartis Investigative Site - Brisbane
Recruitment hospital [3] 0 0
Novartis Investigative Site - Melbourne
Recruitment hospital [4] 0 0
Novartis Investigative Site - Port Macquarie
Recruitment hospital [5] 0 0
Novartis Investigative Site - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Port Macquarie
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Porto Alegre
Country [2] 0 0
Brazil
State/province [2] 0 0
Santo Andre
Country [3] 0 0
Brazil
State/province [3] 0 0
Sao Paulo
Country [4] 0 0
China
State/province [4] 0 0
Beijing
Country [5] 0 0
China
State/province [5] 0 0
Chongqing
Country [6] 0 0
China
State/province [6] 0 0
Shanghai
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Busan
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Kyunggi-do
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Seoul
Country [10] 0 0
Kuwait
State/province [10] 0 0
Kuwait
Country [11] 0 0
Lebanon
State/province [11] 0 0
Beirut
Country [12] 0 0
New Zealand
State/province [12] 0 0
Auckland
Country [13] 0 0
New Zealand
State/province [13] 0 0
Christchurch
Country [14] 0 0
New Zealand
State/province [14] 0 0
Hamilton
Country [15] 0 0
New Zealand
State/province [15] 0 0
Tauranga
Country [16] 0 0
New Zealand
State/province [16] 0 0
Wellington
Country [17] 0 0
Saudi Arabia
State/province [17] 0 0
Riyadh
Country [18] 0 0
Taiwan
State/province [18] 0 0
Taichung
Country [19] 0 0
Taiwan
State/province [19] 0 0
Taipei
Country [20] 0 0
Taiwan
State/province [20] 0 0
Taoyuan
Country [21] 0 0
Thailand
State/province [21] 0 0
Bangkok
Country [22] 0 0
Thailand
State/province [22] 0 0
Songkhla

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/show/NCT00242567
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications