Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis

Novartis

Status and phase

Completed

Phase 4

Conditions

Prostate Cancer With Bone Metastasis

Treatments

Drug: zoledronic acid

Study type

Interventional

Funder types

Industry

Identifiers

CZOL446EFR04

Details and patient eligibility

About

Study to determine effectiveness and safety of zoledronic acid and whether it has a pharmaco-economic impact in prostate cancer with bone metastasis.

Enrollment

148 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged ≥18 years.
Written informed consent.
With histologically-proven prostate carcinoma.
ECOG performance status ≤ 2
Life expectancy > 12 months
Current or previously documented diagnosis of at least 1 bone metastasis due to prostate cancer (patient could be hormono naif, Hormono sensible or hormono refractory)
Patients with partners of childbearing potential should use a barrier method of contraception throughout the study.

Exclusion criteria

ECOG performans status >3
Prior treatment with bisphosphonates IV within the last 3 month to the study
Renal insufficiency (serum creatinine > 265 micromol/L or > 3.0 mg/dL)
Liver function tests > 2.5 ULN
Patients with another nonmalignant disease which would confuse the evaluation of primary endpoints or prevent the patient from complying with the protocol.
History of concomitant disease with influence on bone metabolism such as Paget's disease or primary hyperparathyroidism
Disabling or non controlled concomitant disease likely to alter the quality of life
Patient unable to fill in a questionnaire: senile dementia, psychiatric or neurological disease, illiterate or partially sighted patient
Known hypersensitivity to zoledronic acid or other bisphosphonates

Other protocol-defined inclusion / exclusion criteria may apply.