Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer

Prostate Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242567
• Other study ID #: CZOL446E2432
• Status: Completed
• Phase: Phase 3
• First received: October 19, 2005
• Last updated: April 14, 2014
• Start date: December 2005
• Est. completion date: January 2012

Study information

• Verified date: April 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research CouncilBrazil: Ministry of HealthChina: Ministry of HealthKorea: Food and Drug AdministrationKuwait: Joint Committee for the Protection of Human Subjects in ResearchLebanon: Ministry of Public HealthNew Zealand: Ministry of HealthSaudi Arabia: Ministry of HealthTaiwan : Food and Drug AdministrationThailand: Food and Drug Administration
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• prostate cancer

• at least one bone metastasis

• receiving or about to receive androgen deprivation therapy (ADT)

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Australia	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
Brazil	Novartis Investigative Site	Porto Alegre
Brazil	Novartis Investigative Site	Santo Andre
Brazil	Novartis Investigative Site	Sao Paulo
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Chongqing
China	Novartis Investigative Site	Shanghai
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Kyunggi-do
Korea, Republic of	Novartis Investigative Site	Seoul
Kuwait	Novartis Investigative Site	Kuwait
Lebanon	Novartis Investigative Site	Beirut
New Zealand	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
Saudi Arabia	Novartis Investigative Site	Riyadh
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taoyuan
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Brazil,  China,  Korea, Republic of,  Kuwait,  Lebanon,  New Zealand,  Saudi Arabia,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	month 18, year 3	Yes
Secondary	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.	18 Months	Yes
Secondary	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.	36 months	No
Secondary	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.	36 Months	Yes