Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Zoledronic acid, Bone metastasis
Eligibility Criteria
Inclusion Criteria: Age ≥18 histologically confirmed adenocarcinoma of the prostate. Orchidectomy within the four previous weeks to enter the study. bone metastasis evidenced by bone scan. A hip DEXA study with a DS < 3. No hormonal therapy previous to enter the study. ECOG performance score of 0-2. Signed written informed consent. Exclusion Criteria: Abnormal renal function evidenced by a creatinine clearance ≤60 ml/min. Any kind of hormonal therapy for prostate cancer previous to enter the study. Serum calcium corrected for albumin level < 8.0 mg/dl. WBC < 3.0x10^3, ANC < 1500/mm3, Hemoglobin < 8.0 g/dl, platelets < 75 x 10^3/l. Abnormal hepatic function evidenced by ALT and AST value >2.5 UNL Subjects with any other malignant disease that can affect the bone. Subjects with any other non malignant disease that can jeopardize the evaluation of the primary objectives of this trial (severe osteoporosis) or that do not aloud perform the trial evaluations. Known hypersensibility to zoledronic acid or other bisphosphonates. Subjects that in the investigator's opinion can not cooperate with the protocol. Other protocol inclusion/exclusion criteria may apply.
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Experimental
Zoledronic Acid