Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of 4 mg zoledronic acid administered intravenously every 3-4 weeks in the treatment of bone metastases-related pain in patients with prostate cancer.

Official Title
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Assessment of the Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer

Conditions
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Pain

Intervention / Treatment
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* Drug: Zoledronic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven adenocarcinoma of the prostate Bone-scan documented metastases Age > 18 years Non-controlled bone pain despite systemic anti-tumor therapy (hormone or chemotherapy) initiated at least 4 weeks before inclusion Life expectancy > 3 months Written informed consent Exclusion Criteria: New systemic anti-tumor therapy initiated less than 4 weeks before study entry or predictable need for starting a new treatment within 8 weeks Radiation therapy on bone target lesions or bone-targeted isotope therapy (strontium or samarium) completed less than 4 weeks before study entry Bisphosphonate therapy within 8 weeks before study entry Abnormal renal function (serum creatinine > 2 x the upper normal limit or creatinine clearance < 30 ml/min) Corrected serum calcium > 3 mmol/L or < 2 mmol/L Clinically relevant hypersensitivity to zoledronic acid, or another bisphosphonate, or one component present in the formulation of the study drug Severe concomitant medical condition that could hamper patient's quality of life or influence the interpretation of pain Patients unable to fill in a questionnaire (neurologic or psychiatric conditions, illiteracy, etc.) Other protocol-defined 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 |
| --- | --- |
| Experimental: zoledronate<br> | Drug: Zoledronic acid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to measure the intensity of the pain relief of the patients at the end of treatment with a five classes score (TOTPAR = TOTal PAin Relief) |  | at 12 weeks or at 16 weeks (end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the intensity of the pain relief of the patients with the PAR at each visit |  | every 3 or 4 weeks during 12 to 16 weeks | 
| To evaluate the pain variation with VAS between V1 and V2, V3, V4, V5. |  | every 3 or 4 weeks during 12 to 16 weeks | 
| To evaluate the pain variation with BPI (=Brief Pain Inventory) and correlate with VAS (=Visual Analog Scale) |  | every 3 or 4 weeks during 12 to 16 weeks | 
| To evaluate the use of analgesic (analgesic score) and the number of patients needing an analgesic radiotherapy between V1 and V5 |  | every 3 or 4 weeks during 12 to 16 weeks | 
| To evaluate the duration of responses |  | at 12 weeks or at 16 weeks (end of treatment) | 
| To evaluate the number of skeletal related events by patient |  | every 3 or 4 weeks during 12 to 16 weeks | 
| To evaluate the effect on functional disability, professional activity (BPI), the PS and overall condition (VAS) between V1 and V5 |  | every 3 or 4 weeks during 12 to 16 weeks | 
| To evaluate the variations of PSA (=Prostate specific Antigen) between V1 and End of study or premature withdrawal |  | at 12 weeks or at 16 weeks (end of treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate, Cancer, Bone metastases, Zoledronic acid, Bone metastases-related pain, Prostate cancer