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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

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.