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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zoledronic Acid
Androgen Deprivation Therapy (ADT)
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring zoledronic acid, bone metastases, prostate cancer, hormone-sensitive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early Group

Delayed group

Arm Description

Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 19, 2005
Last Updated
April 14, 2014
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00242567
Brief Title
Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
zoledronic acid, bone metastases, prostate cancer, hormone-sensitive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
522 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Group
Arm Type
Experimental
Arm Description
Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
Arm Title
Delayed group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Androgen Deprivation Therapy (ADT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Overall Survival at 18 Months and 3 Years
Description
Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause.
Time Frame
month 18, year 3
Title
Time to Occurrence of Skeletal Related Event or Death
Description
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.
Time Frame
18 Months
Title
Skeletal-related Event(SRE)-Free Survival
Description
Time from randomization until the first detected SRE. Patients who were still SRE-free at 3 years were censored.
Time Frame
36 months
Title
Time to Occurrence of Skeletal Related Event or Death
Description
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.
Time Frame
36 Months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Adelaide
Country
Australia
Facility Name
Novartis Investigative Site
City
Brisbane
Country
Australia
Facility Name
Novartis Investigative Site
City
Melbourne
Country
Australia
Facility Name
Novartis Investigative Site
City
Port Macquarie
Country
Australia
Facility Name
Novartis Investigative Site
City
Sydney
Country
Australia
Facility Name
Novartis Investigative Site
City
Porto Alegre
Country
Brazil
Facility Name
Novartis Investigative Site
City
Santo Andre
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Paulo
Country
Brazil
Facility Name
Novartis Investigative Site
City
Beijing
Country
China
Facility Name
Novartis Investigative Site
City
Chongqing
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
Country
China
Facility Name
Novartis Investigative Site
City
Busan
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Kyunggi-do
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Kuwait
Country
Kuwait
Facility Name
Novartis Investigative Site
City
Beirut
Country
Lebanon
Facility Name
Novartis Investigative Site
City
Auckland
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Christchurch
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Hamilton
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Tauranga
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Wellington
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Riyadh
Country
Saudi Arabia
Facility Name
Novartis Investigative Site
City
Taichung
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taoyuan
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Bangkok
Country
Thailand
Facility Name
Novartis Investigative Site
City
Songkhla
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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