ZOMETA® (Zoledronic Acid) for Prevention of Bone Metastases

April 30, 2012 updated by: Central European Cooperative Oncology Group

Randomised Open-label Multicenter Prosp. Clinical Study to Show the Efficacy of IV ZOMETA® 4mg for Prevention of Bone Metastases in Hormone-naïve High Risk Patients With Locally Advanced Prostate Cancer

To determine if therapy with Zometa® (zoledronic acid) 4mg will be effective in preventing the occurrence of bone metastases in prostate cancer patients at high risk of developing them. In addition, pain and analgesic scores and overall safety are to be evaluated throughout the study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, stratified open-label (Zometa + hormonal ablation versus hormonal ablation alone) multicenter clinical study evaluating the efficacy of Zometa 4mg given every 3 month as an adjunct to hormonal or surgical castration for prevention of bone metastases in locally advanced, high risk prostate cancer patients, who are hormone-naiv at time of randomization. the primary efficacy variable is the time to occurrence of first bone metastases.

Zometa® (zoledronic acid) provided as 4mg lyophilised powder Supplementation 500mg Calcium +400-500IU Vitamin D p.o. qd

Arm A:

Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months

Arm B:

no reference therapy

Study Type

Interventional

Enrollment (Actual)

376

Phase

  • Phase 3

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

  • Austria
      • Baden bei Wien, Austria
        • Thermenkh Baden, Urologie
      • Graz, Austria
        • LKH Graz Univ. Klinik f Urologie
      • Innsbruck, Austria
        • LKH Innsbruck, Dept f. Urologie
      • Linz, Austria
        • KH d Elisabethinen Linz, Dep of Urology
      • Linz, Austria
        • KH der Barmherzigen Schwestern, Dept Urologie
      • Salzburg, Austria
        • LKH Salzburg, Clinic f Radiotherapy a Radiooncology
    • Steiermark
      • Leoben, Steiermark, Austria, 8700
        • LKH Leoben, Abt. für Innere Medizin
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina
        • Institute for Oncology
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Plovdiv Cancer Center
      • Sofia, Bulgaria, 1527
        • SBALO National Oncology Center
      • Sofia, Bulgaria
        • SBALO National Oncology Center
      • Sofia, Bulgaria
        • Sofia Cancer Center compl. Mladost ,
      • Stara Zagora, Bulgaria
        • MODOSZ Oncology Dispensary
      • Tarnovo, Bulgaria
        • Modozs-Veliko
      • Varna, Bulgaria
        • Oncological Hospital
  • Croatia
      • Split, Croatia
        • Univ. Hospital, Dep of Pathophysiology
      • Varazdin, Croatia
        • GH, Dep Oncology and Reumatology
      • Zagreb, Croatia
        • Clinical Hospital
  • Czech Republic
      • Brno, Czech Republic
        • FH, Urological Clinic
      • Kromeriz, Czech Republic
        • Hospital Kromeriz, Dep of Urology
      • Prague, Czech Republic
        • FN Motol, Dep of Urology
      • Usti Nad Labem, Czech Republic
        • Centre of Oncology
  • Estonia
      • Tallinn, Estonia
        • Mustamae Korpus
      • Tartu, Estonia
        • Clinic of surgery
  • Hungary
      • Budapest, Hungary
        • Dept. Of Urology , Jahn Ferenc Delpesti Hospital
      • Budapest, Hungary
        • karolyi sandor Hospital, Dept of Urology
      • Budapest, Hungary
        • Semmelweiss Univ of Medicine, Clinic of Urology
      • Pecs, Hungary
        • Univ. of Pecs,Urologic Clinic
      • Szombathely, Hungary
        • Dept. Of Urology and Surgery
  • Lithuania
      • Vilnius, Lithuania
        • Lithuanian Oncology Center
  • Montenegro
      • Podgorica, Montenegro
        • Clinical Center of Montenegro
  • Poland
      • Krakow, Poland
        • Centrum Onkologii Instytut
      • Szczecin, Poland
        • Medical Academy
      • Warsaw, Poland
        • Medical Academy
      • Warsaw, Poland
        • Central Rail Hospital,
  • Romania
      • Brasov, Romania
        • P.D.R. Clinic
      • Bucharest, Romania
        • Fundeni Hospital, Dep of Urology
      • Bucharest, Romania
        • Saint John Emergency Clinical Hospital
      • Cluj-Napoca, Romania, 400015
        • Institutul Oncologic Cluj
      • Craiova, Romania
        • Emergency Clinical County Hospital , Clin Oncol. Dep
      • Iasi, Romania
        • University Hospital
  • Russian Federation
      • Moscow, Russian Federation
        • Hertzen Research Oncological Institute
      • Obninsk, Russian Federation
        • Medical Radiological Research Center
  • Serbia
      • Belgrade, Serbia
        • Clinical Center of Serbia
      • Belgrade, Serbia
        • Oncology Institute Belgrade
      • Belgrade, Serbia
        • Oncology Institute
      • Nis, Serbia
        • Clinical Center
      • Sremska Kamenica, Serbia
        • Institute for Oncology
  • Slovakia
      • Bratislava, Slovakia
        • FNsP - akad L. Derea Urology
      • Kosice, Slovakia
        • FNsP Dep of Urology
      • Martin, Slovakia
        • FN sP Dep of Urology
  • Slovenia
      • Ljubljana, Slovenia
        • University Clinical Center
      • Maribor, Slovenia
        • Gh, Dep of Urology
  • South Africa
      • Claremont, South Africa
        • Turret House
      • Johannesburg, South Africa
        • Johannesburg Hospital Dep of Urology
      • Pietermaritzburg, South Africa
        • St. Annes Hospital
      • Pretoria, South Africa
        • Urological Hospital

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

14 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
  • ECOG performance status of 0, 1, or 2
  • No radiological evident bone metastasis (negative bone scan or verification of suspected foci as benign lesions by additional radiological examination)
  • T3-4 AND highest pre-study PSA >20 ng/ml AND Gleason score = 8 (or Gleason grade = 4)
  • Patients with prior prostatectomy or prior local radiotherapy are eligible for this study
  • Patients are destined to receive medical (LHRH analogue) or surgical (orchiectomy) castration and Zometa® treatment will start not later than 6 weeks after surgery
  • Patients should be fully recovered from prior interventions where applicable

Exclusion Criteria:

  • Patients with a serum creatinine determination >265 µmol/L (3.0 mg/dL)
  • Patients that received prior medical (LHRH analogue) castration
  • Current (or previous) evidence of metastatic disease to the bone
  • History of any other neoplasm within the past five years except for nonmelanomatous skin cancer.
  • Previous hormonal therapy with LHRH agonists or other forms of hormonal ablation
  • WBC<3.0x109, ANC < 1500/mm3, Hgb<8.0 g/dL, platelets < 75 x 109/L
  • Liver function tests >2.5 ULN
  • Prior treatment with Zometa® (zoledronic acid) or other bisphosphonates
  • Treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to the date of randomization (Visit 2)
  • Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of randomization (Visit 2)
  • Patients with evidence in the six months prior to randomization of severe cardiovascular disease (defined as uncontrolled congestive heart failure), hypertension refractory to treatment, or symptomatic coronary artery disease uncontrolled by treatment
  • History of noncompliance to medical regimens and patients who are considered potentially unreliable or incapable of giving informed consent as judged by the investigator.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: zoledronic acid
Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months
Drug: Zometa
Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months
No Intervention: no intervention
no reference therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to occurrence of first bone metastasis, as assessed by bone scan and confirmed by additional radiological examination

Secondary Outcome Measures

Outcome Measure
To assess the effects of i.v. Zometa® (zoledronic acid) 4 mg, with respect to the following efficacy parameters as well as safety and tolerability:
Effects on pain and analgesic drug consumption, assessed by the composite pain score from BPI (Brief Pain Inventory) for pain and by analgesic score
Time to first event of bone pain
Time to first occurrence of Skeletal Related Events (SREs), defined as pathologic bone fractures, spinal cord compression, surgery to bone, radiation therapy to bone (including the use of radioisotopes)
Proportion of patients in each arm having SRE
Serum PSA
Overall safety

Collaborators and Investigators

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

Sponsor

Central European Cooperative Oncology Group

Investigators

  • Principal Investigator: Bobak Djavan, Prof, Univ. Klinik für Urologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

December 1, 2003

Primary Completion (Actual)

December 1, 2003

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

February 20, 2006

First Submitted That Met QC Criteria

February 20, 2006

First Posted (Estimate)

February 22, 2006

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 30, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CECOG/prostate 1.2.001

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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