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

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

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Prostate Cancer With at Least One Bone Lesion in Patients Receiving Hormonal Therapy and Treatment With Bisphosphonates is Indicated

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ZOL446 (zoledronic acid)

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

Interventions

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Zoledronic acid

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No