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

Novartis

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: Zoledronic Acid; Drug: Androgen Deprivation Therapy (ADT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00242567

CZOL446E2432

Details and patient eligibility

About

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

Enrollment: 522 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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522 participants in 2 patient groups

Early Group

Experimental group

Description:

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

Treatment:

Drug: Zoledronic Acid

Delayed group

Experimental group

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.

Treatment:

Drug: Androgen Deprivation Therapy (ADT)