Status:
COMPLETED
Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases
Lead Sponsor:
Novartis
Collaborating Sponsors:
Società Italiana di Urologia (SIU)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
The present study will give information about the course over time in skeletal-related events (SRE) in prostate cancer patients with bone metastases treated with zoledronic acid 4 mg administered as a...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients aged ≥18 years
- Written informed consent
- Histologically-proven prostate carcinoma
- ECOG performance status ≤ 2
- Life expectancy \> 6 months
- Newly diagnosed (≤ 6 months prior to visit 1) bone metastases evidenced by bone scan or radiograph.
- Patients on androgen deprivation therapy (medical therapy with LHRH analogues + antiandrogens or surgical castration) or going to start it
- Patients with partners of childbearing potential should use a barrier method of contraception throughout the study
- Exclusion Criteria
- Patients without a history of metastatic disease to the bone
- Prior treatment with bisphosphonates
- SREs prior to visit 2
- Prior treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to baseline
- Corrected (adjusted for serum albumin - see Appendix 5 for the calculation) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/l)
- Serum creatinine concentration \> 265 micromol/l (3.0 mg/dl) or a calculated creatinine clearance \< 30 ml/minute or serious underlying renal disease or prior renal transplantation
- History of other malignant neoplasm within previous five years with exception of non-melanomatous skin cancer which has been satisfactorily treated
- Other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future
- Patients treated with systemic investigational drug(s) and/or device(s) within the past 30 days or topical investigational drugs within the past 7 days
- Known hypersensitivity to zoledronic acid or other bisphosphonates
- History of noncompliance to medical regimens and patients who are considered potentially unreliable (for example drug or alchohol abusers) or incapable of giving informed consent as judged by the investigator
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00219219
Start Date
September 1 2003
End Date
October 1 2006
Last Update
April 14 2015
Active Locations (1)
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1
Bologna
Bologna, Italy