Prostate Cancer With Bone Metastasis Clinical Trial
Official title:
Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis
| Verified date | April 2010 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Study to determine effectiveness and safety of zoledronic acid and whether it has a pharmaco-economic impact in prostate cancer with bone metastasis.
| Status | Completed |
| Enrollment | 148 |
| Est. completion date | |
| Est. primary completion date | January 2006 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | to assess the effectiveness of Zol in prevention of SREs in stratified groups (hormonal treatment) | at 15 months & at end of study | ||
| Secondary | to assess the effectiveness of Zol in improving pain and QoL in prostate cancer patients with bone metastases | V1, V2, V3, V5 | ||
| Secondary | to assess the safety of ZOL treatment | V1, V2, V3, V5 | ||
| Secondary | to assess resources consumption | V1, V2, V3, V5 | ||
| Secondary | to assess BM | V1 et V5 |