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

This study is ongoing, but not recruiting participants.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00237146

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: Zoledronic acid	Phase IV

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

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

Further study details as provided by Novartis:

Study Start Date:

November 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237146

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CZOL446EVE01
Study First Received:	October 9, 2005
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00237146
Health Authority:	Venezuela: Instituto Nacional de Higiene

Keywords provided by Novartis:

Prostate cancer
Zoledronic acid
Bone metastasis

Study placed in the following topic categories:

Diphosphonates
Zoledronic acid
Prostatic Diseases
Genital Neoplasms, Male
Neoplasm Metastasis

Quality of Life
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009