A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates

Phase 4

Completed

• Conditions: Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated
• Interventions: Drug: Zoledronic acid

• Registration Number: NCT00172016
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The purpose of this study is to assess the efficacy and tolerability of zoledronic acid in preventing skeletal-related events in patients with prostate cancer

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2005-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-27
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 43

Inclusion Criteria

• Written informed consent must be obtained
• Age > 18 years
• Histologically confirmed diagnosis of carcinoma of the prostate
• Current (or previous) objective evidence of metastatic disease to the bone
• Currently receiving 1st line hormonal therapy with LHRH agonists or other hormonal treatments
• 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 (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)
• WBC<3.0x1'000'000'000, ANC < 1500/mm3, Hgb<8.0 g/dL, platelets < 75 x 1'000'000'000/L.
• Liver function tests >2.5 ULN, serum creatinine >1.5 ULN.
• Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
• Known hypersensitivity to zoledronic acid or other bisphosphonates
• Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study

Other protocol-defined inclusion / exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZOL446 (zoledronic acid)	Zoledronic acid	-