Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer
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.
1 other identifier
interventional
522
10 countries
27
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 prostate-cancer
Started Dec 2005
Typical duration for phase_3 prostate-cancer
27 active sites
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
First Submitted
Initial submission to the registry
October 19, 2005
CompletedFirst Posted
Study publicly available on registry
October 20, 2005
CompletedStudy Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
March 6, 2013
CompletedMay 7, 2014
April 1, 2014
6.1 years
October 19, 2005
January 29, 2013
April 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
18 months
Secondary Outcomes (4)
Overall Survival at 18 Months and 3 Years
month 18, year 3
Time to Occurrence of Skeletal Related Event or Death
18 Months
Skeletal-related Event(SRE)-Free Survival
36 months
Time to Occurrence of Skeletal Related Event or Death
36 Months
Study Arms (2)
Early Group
EXPERIMENTALZoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
Delayed group
EXPERIMENTALZoledronic 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.
Interventions
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) 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.
Eligibility Criteria
You may qualify if:
- prostate cancer
- at least one bone metastasis
- receiving or about to receive androgen deprivation therapy (ADT)
You may not qualify if:
- previous ADT failure
- previous or current treatment with another bone-protecting agent, chemotherapy or targeted therapy
- abnormal renal function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Novartis Investigative Site
Adelaide, Australia
Novartis Investigative Site
Brisbane, Australia
Novartis Investigative Site
Melbourne, Australia
Novartis Investigative Site
Port Macquarie, Australia
Novartis Investigative Site
Sydney, Australia
Novartis Investigative Site
Porto Alegre, Brazil
Novartis Investigative Site
Santo André, Brazil
Novartis Investigative Site
São Paulo, Brazil
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Chongqing, China
Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Kuwait City, Kuwait
Novartis Investigative Site
Beirut, Lebanon
Novartis Investigative Site
Auckland, New Zealand
Novartis Investigative Site
Christchurch, New Zealand
Novartis Investigative Site
Hamilton, New Zealand
Novartis Investigative Site
Tauranga, New Zealand
Novartis Investigative Site
Wellington, New Zealand
Novartis Investigative Site
Riyadh, Saudi Arabia
Novartis Investigative Site
Busan, South Korea
Novartis Investigative Site
Kyunggi-do, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Taichung, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Taoyuan District, Taiwan
Novartis Investigative Site
Bangkok, Thailand
Novartis Investigative Site
Songkhla, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2005
First Posted
October 20, 2005
Study Start
December 1, 2005
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
May 7, 2014
Results First Posted
March 6, 2013
Record last verified: 2014-04