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

This study has been completed.

First Received: September 13, 2005 Last Updated: September 15, 2006 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00172016

Purpose

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

Condition	Intervention	Phase
Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated	Drug: Zoledronic acid	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by Novartis:

Study Start Date:

January 2004

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00172016

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

No publications provided

Study ID Numbers:	CZOL446EHU01
Study First Received:	September 13, 2005
Last Updated:	September 15, 2006
ClinicalTrials.gov Identifier:	NCT00172016 History of Changes
Health Authority:	Hungary: National Institute of Pharmacy

Keywords provided by Novartis:

Zoledronic acid
SRE
Prostate cancer

Study placed in the following topic categories:

Diphosphonates
Zoledronic acid
Prostatic Diseases
Genital Neoplasms, Male

Bone Density Conservation Agents
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Diphosphonates
Zoledronic acid
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Physiological Effects of Drugs
Bone Density Conservation Agents
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009