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 Overview
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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.

Official Title
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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.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Zoledronic acid


Participation Criteria
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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. Other protocol inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zoledronic Acid<br> | Drug: Zoledronic acid<br> <br> * Other names: ZOL446;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Zoledronic acid, Bone metastasis