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

Phase 4

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Zoledronic acid

• Registration Number: NCT00237146
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-10-09
• Study First Submitted QC: 2005-10-09
• Study First Posted: 2005-10-12
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 38

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zoledronic Acid	Zoledronic acid	-

Primary Outcome Measures

Name	Time	Method
Evaluate the effects of Zometa® (Zoledronic Acid) i.v in doses of 4mg for measure the following parameters of efficacy: Quality of Life, Incidence of Events related to the skeleton

Trial Locations

Locations (1)

Novartis Investigative Site; 🇻🇪 Caracas, Venezuela