Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis

November 20, 2009 updated by: Novartis Pharmaceuticals

An Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Mineral Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis

The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic acid for injection in 100mg solution ) has in preventing associated bone loss in prostate cancer patients with bone metastasis when administered in conjunction with hormonal cancer therapy. This trial will seek to determine the effect of ZOMETA in stabilizing and increasing bone mineral density in these patients.

This prospective, open-label, single arm, multicenter study will enroll approximately 200 prostate cancer patients with a history of at least one documented bone lesion documented by bone scan or radiograph. Patients must already be receiving hormone therapy and meet the following additional criteria:

  • 18 years of age or older
  • Histologically confirmed diagnoses of prostate cancer
  • Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or radiograph
  • Received or will receive hormonal treatment also know as androgen deprivation therapy with an LHRH agonist or other hormonal treatments

Throughout the course of this 12-month trial, patients will be identified based on the duration of established hormonal treatment at the time of enrollment. Each patients duration of participation will be up to 56 weeks including a 4 week screening, 48 week treatment and a 4 week follow up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35234
        • Norwood Clinic
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Clinical Research Center, LLC
    • California
      • Anaheim, California, United States, 92801
        • Advanced Urology Medical Center
      • Fresno, California, United States, 93720
        • Urology Associates of Central CA
      • La Mesa, California, United States, 91942
        • Center for Urological Research
      • Long Beach, California, United States, 90806
        • Atlantic Urological Medical Group
      • Los Angeles, California, United States, 90045
        • Advanced Urology Medical Offices
      • Los Angeles, California, United States, 90045
        • Advanced Urology Medical Office
    • Colorado
      • Boulder, Colorado, United States
        • Boulder Medical Center
      • Denver, Colorado, United States, 80210
        • Urology Associates, P.C.
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Atlantic Urological Associates
      • Fort Myers, Florida, United States
        • Southwest Florida Urologic Association
      • Largo, Florida, United States, 33773
        • DMI Health Care Group, Inc.
      • Largo, Florida, United States, 33770
        • Diagnostic Clinic
      • Margate, Florida, United States, 33063
        • Marvin Stein, MD
      • Miami, Florida, United States, 33143
        • Miami Cancer Institute
      • New Port Richey, Florida, United States, 34652
        • Advanced Research Institute
      • Ocala, Florida, United States, 34474
        • Florida Foundation for Healthcare Research
      • Orange Park, Florida, United States, 32073
        • Urology Associates of Northeast Florida, PA
      • Orlando, Florida, United States, 32803
        • Winter Park Urology Associates
      • St. Petersburg, Florida, United States, 33710
        • Pinellas Urology, Inc.
      • Tallahassee, Florida, United States, 32308
        • Southeastern Urological Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Georgia Urology Research Institute
    • Indiana
      • Muncie, Indiana, United States, 47303
        • Ball Memorial Hospital
    • Iowa
      • Davenport, Iowa, United States, 52807
        • Urological Associates PC
    • Maryland
      • Greenbelt, Maryland, United States, 20770
        • Drs. Werner, Murdock and Francis PA Urology Associates
    • Massachusetts
      • Marlborough, Massachusetts, United States, 01752
        • Urology Associates of Middlesex County, Inc.
    • Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Lakeside Urology, P.C.
      • Southfield, Michigan, United States, 48075
        • Millennium Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Kansas City Urology Care
      • St. Louis, Missouri, United States, 63136
        • The Prostate Center of Greater St. Louis
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • American Academy of Urology
    • New Jersey
      • Edison, New Jersey, United States
        • Urological Surgical Associates
      • Morristown, New Jersey, United States, 07960
        • UroResearch, LLC
      • Pennsville, New Jersey, United States, 08070
        • Shaukat M. Qureshi, MD
      • Stratford, New Jersey, United States
        • Urology Associates
      • West Orange, New Jersey, United States, 07052
        • Associates in Urology, LLC
    • New York
      • Garden City, New York, United States, 11530
        • AccuMed Research Associates
      • Garden City, New York, United States, 11530
        • Urological Surgeons of Long Island PC
      • Kingston, New York, United States, 12401
        • Kingston Urological Assoc.
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • Cary Urology, P.A.
      • Greenville, North Carolina, United States, 29607
        • Matrix Research, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • The Urology Group
      • Parma, Ohio, United States, 44129
        • Southwest Urology
    • Pennsylvania
      • Arcadia, Pennsylvania, United States, 91007
        • Roger N. Andrews, MD Inc.
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • Urologic Surgery, PC
      • Bryn Mawr, Pennsylvania, United States, 09010
        • James W. Thompson, MD Ltd.
      • Monroeville, Pennsylvania, United States, 15146
        • Urology Institute of Pittsburgh
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
      • West Reading, Pennsylvania, United States, 19611
        • Center for Urologic Care of Berks County
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Grand Strand Urology
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Urology Center of the South P.C.
      • Murfreesboro, Tennessee, United States, 37130
        • Murfreesboro Medical Clinic
      • Nashville, Tennessee, United States, 37209
        • Urology Associates, PA
    • Texas
      • Carrollton, Texas, United States, 75010
        • Research Across America
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion criteria:

  • Signed informed consent
  • Age > 18 years
  • Histologically confirmed diagnosis of carcinoma of the prostate
  • Objective evidence of metastatic disease to the bone as evidenced by bone scan or radiograph at any point since their diagnosis of prostate cancer
  • Currently receiving, or will begin receiving, hormonal therapy with an LHRH agonist or other hormonal treatments for either < 6 months or > 6 months
  • ECOG performance status of 0, 1, or 2

Exclusion criteria:

  • Patients who are hormone sensitive without metastatic disease to the bone
  • Patients who are hormone refractory typically defined as two or three consecutive increases in PSA measured at least one month apart while on hormone therapy
  • Patients who are not treated with LHRH agonist or other hormonal treatments
  • Patients who are currently receiving diethylstilbestrol (DES) or PC-SPES
  • Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
  • Patients with abnormal renal function as evidenced by either a serum creatinine greater than 2 mg/dL 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Changes in bone mineral density of the lumbar spine (L2-L4) at 12 months

Secondary Outcome Measures

Outcome Measure
Changes in biochemical markers of bone turnover over 12 months
Changes in bone mineral density of the total hip at 12 months
Time to first skeletal-related event
Overall safety measured by adverse events (AEs)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Scott L. Pescatore, PharmD., Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (ACTUAL)

January 1, 2004

Study Completion (ACTUAL)

January 1, 2004

Study Registration Dates

First Submitted

May 7, 2002

First Submitted That Met QC Criteria

May 7, 2002

First Posted (ESTIMATE)

May 8, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

November 23, 2009

Last Update Submitted That Met QC Criteria

November 20, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446EUS24
  • US24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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