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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00242567
First received: October 19, 2005
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: Zoledronic Acid
Drug: Androgen Deprivation Therapy (ADT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: month 18, year 3 ] [ Designated as safety issue: Yes ]
    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 Frame: 18 Months ] [ Designated as safety issue: Yes ]
    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 Frame: 36 months ] [ Designated as safety issue: No ]
    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 Frame: 36 Months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 522
Study Start Date: December 2005
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early Group
Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
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.

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.
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242567

Locations
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, Australia
Brazil
Novartis Investigative Site
Porto Alegre, Brazil
Novartis Investigative Site
Santo Andre, Brazil
Novartis Investigative Site
Sao Paulo, Brazil
China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Chongqing, China
Novartis Investigative Site
Shanghai, China
Korea, Republic of
Novartis Investigative Site
Busan, Korea, Republic of
Novartis Investigative Site
Kyunggi-do, Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Republic of
Kuwait
Novartis Investigative Site
Kuwait, Kuwait
Lebanon
Novartis Investigative Site
Beirut, Lebanon
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, New Zealand
Saudi Arabia
Novartis Investigative Site
Riyadh, Saudi Arabia
Taiwan
Novartis Investigative Site
Taichung, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Taoyuan, Taiwan
Thailand
Novartis Investigative Site
Bangkok, Thailand
Novartis Investigative Site
Songkhla, Thailand
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00242567     History of Changes
Other Study ID Numbers: CZOL446E2432
Study First Received: October 19, 2005
Results First Received: January 29, 2013
Last Updated: April 14, 2014
Health Authority: Australia: National Health and Medical Research Council
Brazil: Ministry of Health
China: Ministry of Health
Korea: Food and Drug Administration
Kuwait: Joint Committee for the Protection of Human Subjects in Research
Lebanon: Ministry of Public Health
New Zealand: Ministry of Health
Saudi Arabia: Ministry of Health
Taiwan : Food and Drug Administration
Thailand: Food and Drug Administration

Keywords provided by Novartis:
zoledronic acid
bone metastases
prostate cancer
hormone-sensitive

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Zoledronic acid
Diphosphonates
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 22, 2014