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

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

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.

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.