Clinical trial NCT00375648: Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer
Official title: Assessment of the Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Prostate
Cancer
Bone metastases
Zoledronic acid
Bone metastases-related pain
Prostate cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-13
Enrollment: 61
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: at 12 weeks or at 16 weeks (end of treatment)
Secondary outcomes:
measure: To measure the intensity of the pain relief of the patients with the PAR at each visit
timeFrame: every 3 or 4 weeks during 12 to 16 weeks
measure: To evaluate the pain variation with VAS between V1 and V2, V3, V4, V5.
timeFrame: every 3 or 4 weeks during 12 to 16 weeks
measure: To evaluate the pain variation with BPI (=Brief Pain Inventory) and correlate with VAS (=Visual Analog Scale)
timeFrame: every 3 or 4 weeks during 12 to 16 weeks
measure: To evaluate the use of analgesic (analgesic score) and the number of patients needing an analgesic radiotherapy between V1 and V5
timeFrame: every 3 or 4 weeks during 12 to 16 weeks
measure: To evaluate the duration of responses
timeFrame: at 12 weeks or at 16 weeks (end of treatment)
measure: To evaluate the number of skeletal related events by patient
timeFrame: every 3 or 4 weeks during 12 to 16 weeks
measure: To evaluate the effect on functional disability, professional activity (BPI), the PS and overall condition (VAS) between V1 and V5
timeFrame: every 3 or 4 weeks during 12 to 16 weeks
measure: To evaluate the variations of PSA (=Prostate specific Antigen) between V1 and End of study or premature withdrawal
timeFrame: at 12 weeks or at 16 weeks (end of treatment)
Other outcomes:
Locations:
city: Monpellier
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: