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

Novartis

Status and phase

Completed

Phase 4

Conditions

Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated

Treatments

Drug: Zoledronic acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT00172016

CZOL446EHU01

Details and patient eligibility

About

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

Enrollment

43 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.