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

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

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

Conditions
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Prostate Cancer With Bone Metastasis

Intervention / Treatment
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* Drug: zoledronic acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Zometa<br> | Drug: zoledronic acid<br> <br> * Other names: ZOl446;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to assess the effectiveness of Zol in prevention of SREs in stratified groups (hormonal treatment) |  | at 15 months & at end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to assess the effectiveness of Zol in improving pain and QoL in prostate cancer patients with bone metastases |  | V1, V2, V3, V5 | 
| to assess the safety of ZOL treatment |  | V1, V2, V3, V5 | 
| to assess resources consumption |  | V1, V2, V3, V5 | 
| to assess BM |  | V1 et V5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate, cancer, bone metastasis, zoledronic acid