Pain
Conditions
Keywords
Prostate, Cancer, Bone metastases, Zoledronic acid, Bone metastases-related pain, Prostate cancer
Brief summary
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.
Interventions
DRUGZoledronic acid
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 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 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) |
| To evaluate the duration of responses | at 12 weeks or at 16 weeks (end of treatment) |
Countries
France
Outcome results
None listed