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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zoledronic Acid

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

Interventions

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Zoledronic acid

Intervention Type DRUG

Other Intervention Names

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ZOL446

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No