AzTrials
AzTrials

Prostate CancerPhase 3NCT00294437

ZOMETA® (Zoledronic Acid) for Prevention of Bone Metastases

A Phase 3 study testing Zometa in people with Prostate Cancer, run by Central European Cooperative Oncology Group at 57 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Zometa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
376 participants
Where
57 sitesin 16 countries
Study dates
Dec 2003to Nov 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

57 sites in 16 countries.

57 sites in 16 countries

Austria7 sites

  • Thermenkh Baden, Urologie

    Baden

  • LKH Graz Univ. Klinik f Urologie

    Graz

  • LKH Innsbruck, Dept f. Urologie

    Innsbruck

  • LKH Leoben, Abt. für Innere Medizin

    Leoben, Styria, 8700

  • KH d Elisabethinen Linz, Dep of Urology

    Linz

  • KH der Barmherzigen Schwestern, Dept Urologie

    Linz

  • LKH Salzburg, Clinic f Radiotherapy a Radiooncology

    Salzburg

Other trials in Austria

Bulgaria7 sites

  • Plovdiv Cancer Center

    Plovdiv, 4000

  • SBALO National Oncology Center

    Sofia, 1527

  • SBALO National Oncology Center

    Sofia

  • Sofia Cancer Center compl. Mladost ,

    Sofia

  • MODOSZ Oncology Dispensary

    Stara Zagora

  • Oncological Hospital

    Varna

  • Modozs-Veliko

    Veliko Tarnovo

Other trials in Bulgaria

Romania6 sites

  • P.D.R. Clinic

    Brasov

  • Fundeni Hospital, Dep of Urology

    Bucharest

  • Saint John Emergency Clinical Hospital

    Bucharest

  • Institutul Oncologic Cluj

    Cluj-Napoca, 400015

  • Emergency Clinical County Hospital , Clin Oncol. Dep

    Craiova

  • University Hospital

    Iași

Other trials in Romania

Hungary5 sites

  • Dept. Of Urology , Jahn Ferenc Delpesti Hospital

    Budapest

  • karolyi sandor Hospital, Dept of Urology

    Budapest

  • Semmelweiss Univ of Medicine, Clinic of Urology

    Budapest

  • Univ. of Pecs,Urologic Clinic

    Pécs

  • Dept. Of Urology and Surgery

    Szombathely

Other trials in Hungary

Serbia5 sites

  • Clinical Center of Serbia

    Belgrade

  • Oncology Institute Belgrade

    Belgrade

  • Oncology Institute

    Belgrade

  • Institute for Oncology

    Kamenitz

  • Clinical Center

    Niš

Other trials in Serbia

Czechia4 sites

  • FH, Urological Clinic

    Brno

  • Hospital Kromeriz, Dep of Urology

    Kroměříž

  • FN Motol, Dep of Urology

    Prague

  • Centre of Oncology

    Ústí nad Labem

Other trials in Czechia

Poland4 sites

  • Centrum Onkologii Instytut

    Krakow

  • Medical Academy

    Szczecin

  • Central Rail Hospital,

    Warsaw

  • Medical Academy

    Warsaw

Other trials in Poland

South Africa4 sites

  • Turret House

    Claremont

  • Johannesburg Hospital Dep of Urology

    Johannesburg

  • St. Annes Hospital

    Pietermaritzburg

  • Urological Hospital

    Pretoria

Other trials in South Africa

Croatia3 sites

  • Univ. Hospital, Dep of Pathophysiology

    Split

  • GH, Dep Oncology and Reumatology

    Varaždin

  • Clinical Hospital

    Zagreb

Other trials in Croatia

Slovakia3 sites

  • FNsP - akad L. Derea Urology

    Bratislava

  • FNsP Dep of Urology

    Košice

  • FN sP Dep of Urology

    Martin

Other trials in Slovakia

Estonia2 sites

  • Mustamae Korpus

    Tallinn

  • Clinic of surgery

    Tartu

Other trials in Estonia

Russia2 sites

  • Hertzen Research Oncological Institute

    Moscow

  • Medical Radiological Research Center

    Obninsk

Other trials in Russia

Slovenia2 sites

  • University Clinical Center

    Ljubljana

  • Gh, Dep of Urology

    Maribor

Other trials in Slovenia

Bosnia and Herzegovina1 site

  • Institute for Oncology

    Sarajevo

Other trials in Bosnia and Herzegovina

Lithuania1 site

  • Lithuanian Oncology Center

    Vilnius

Other trials in Lithuania

Montenegro1 site

  • Clinical Center of Montenegro

    Podgorica

Other trials in Montenegro

About this study

Official title: 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.

Read the 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

Conditions
Prostate Cancer
Being tested
Zometa
Keywords
Prostate Cancer, Zometa
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZometaDrug

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

Study groups in NCT00294437
Study groupRoleWhat they receive
zoledronic acidExperimentalZometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months
Receives: Drug: Zometa
no interventionNo interventionno reference therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

  1. 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:

  2. Effects on pain and analgesic drug consumption, assessed by the composite pain score from BPI (Brief Pain Inventory) for pain and by analgesic score

  3. Time to first event of bone pain

  4. 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)

  5. Proportion of patients in each arm having SRE

  6. Serum PSA

  7. Overall safety

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2006 (estimated)
  2. Study startDec 2003
  3. Primary completionDec 2003
  4. Study completionNov 2007

Why it stopped: underfunding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
376 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00294437
Sponsor's protocol ID
CECOG/prostate 1.2.001
Status last verified
Apr 2012
First submitted
20 Feb 2006
Last updated
1 May 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zometa in people with Prostate Cancer, run by Central European Cooperative Oncology Group at 57 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in Austria, Bulgaria, Romania, Hungary, Serbia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: underfunding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to occurrence of first bone metastasis, as assessed by bone scan and confirmed by additional radiological examination. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00294437.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in