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

NCT ID: NCT00242567

Last Updated: 2014-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 522 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2012-01-31

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Group

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

Group Type: EXPERIMENTAL

Zoledronic Acid

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Androgen Deprivation Therapy (ADT)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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

Countries

Australia; Brazil; China; Kuwait; Lebanon; New Zealand; Saudi Arabia; South Korea; Taiwan; Thailand

Other Identifiers

CZOL446E2432

Identifier Type: -

Identifier Source: org_study_id