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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

An open, multicenter and prospective study to evaluate the impact of the treatment with zoledronic acid 4 mg, on the quality of life and the skeletal-related events in patients with prostate cancer and bone metastasis that responds to hormonal therapy. Zoledronic acid is given to patients in a 15 minute-infusion every 4 weeks until a skeletal-related event occurs.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Diphosphonates; Hormones; Zoledronic Acid

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.