Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases

Novartis

Status and phase

Completed

Phase 4

Conditions

Prostate Cancer

Treatments

Drug: Zoledronic acid

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00219219

CZOL446EIT04

Details and patient eligibility

About

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 15-minute infusion every 4 weeks for a maximum of 15 infusions. The protocol will enroll patients with recent diagnosis of bone metastases from prostate cancer who are hormone-refractory, hormone-naïve or still hormone-sensitive, that represent the entire population of prostate cancer patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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