Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Bone Metastases, Zoledronic acid
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Histological confirmed diagnosis of carcinoma of the prostate Current or previous evidence of metastatic disease to the bone Receiving currently or not, hormonal therapy ECOG performance status of 0, 1, or 2 Exclusion Criteria: Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal, or by a calculated creatinine clearance of 60 ml/minute or less. Corrected serum calcium concentration, adjusted for serum albumin < 8.0 mg/dl (2.00 mmol/L). WBC<3.0x10^9, ANC < 1500/mm3, Hb < 8.0 g/dL, platelets < 75 x 10^9/L. Liver function tests >2.5 ULN, serum creatinine >1.5 ULN. Patients with another non malignant disease, which could confound the evaluation of primary endpoints, or prevent the patient complying with the protocol. Known hypersensitivity to zoledronic acid or other bisphosphonates or each of the compounds which perform the formula. Other protocol-related inclusion / exclusion criteria may apply