Study Stopped
underfunding
ZOMETA® (Zoledronic Acid) for Prevention of Bone Metastases
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
1 other identifier
interventional
376
15 countries
55
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 prostate-cancer
Started Dec 2003
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 20, 2006
CompletedFirst Posted
Study publicly available on registry
February 22, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedMay 1, 2012
April 1, 2012
Same day
February 20, 2006
April 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to occurrence of first bone metastasis, as assessed by bone scan and confirmed by additional radiological examination
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
zoledronic acid
EXPERIMENTALZometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months
no intervention
NO INTERVENTIONno reference therapy
Interventions
Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
LKH Leoben, Abt. für Innere Medizin
Leoben, Styria, 8700, Austria
Thermenkh Baden, Urologie
Baden, Austria
LKH Graz Univ. Klinik f Urologie
Graz, Austria
LKH Innsbruck, Dept f. Urologie
Innsbruck, Austria
KH d Elisabethinen Linz, Dep of Urology
Linz, Austria
KH der Barmherzigen Schwestern, Dept Urologie
Linz, Austria
LKH Salzburg, Clinic f Radiotherapy a Radiooncology
Salzburg, Austria
Institute for Oncology
Sarajevo, Bosnia and Herzegovina
Plovdiv Cancer Center
Plovdiv, 4000, Bulgaria
SBALO National Oncology Center
Sofia, 1527, Bulgaria
SBALO National Oncology Center
Sofia, Bulgaria
Sofia Cancer Center compl. Mladost ,
Sofia, Bulgaria
MODOSZ Oncology Dispensary
Stara Zagora, Bulgaria
Oncological Hospital
Varna, Bulgaria
Modozs-Veliko
Veliko Tarnovo, Bulgaria
Univ. Hospital, Dep of Pathophysiology
Split, Croatia
GH, Dep Oncology and Reumatology
Varaždin, Croatia
Clinical Hospital
Zagreb, Croatia
FH, Urological Clinic
Brno, Czechia
Hospital Kromeriz, Dep of Urology
Kroměříž, Czechia
FN Motol, Dep of Urology
Prague, Czechia
Centre of Oncology
Ústí nad Labem, Czechia
Mustamae Korpus
Tallinn, Estonia
Clinic of surgery
Tartu, Estonia
Dept. Of Urology , Jahn Ferenc Delpesti Hospital
Budapest, Hungary
karolyi sandor Hospital, Dept of Urology
Budapest, Hungary
Semmelweiss Univ of Medicine, Clinic of Urology
Budapest, Hungary
Univ. of Pecs,Urologic Clinic
Pécs, Hungary
Dept. Of Urology and Surgery
Szombathely, Hungary
Lithuanian Oncology Center
Vilnius, Lithuania
Clinical Center of Montenegro
Podgorica, Montenegro
Centrum Onkologii Instytut
Krakow, Poland
Medical Academy
Szczecin, Poland
Central Rail Hospital,
Warsaw, Poland
Medical Academy
Warsaw, Poland
P.D.R. Clinic
Brasov, Romania
Fundeni Hospital, Dep of Urology
Bucharest, Romania
Saint John Emergency Clinical Hospital
Bucharest, Romania
Institutul Oncologic Cluj
Cluj-Napoca, 400015, Romania
Emergency Clinical County Hospital , Clin Oncol. Dep
Craiova, Romania
University Hospital
Iași, Romania
Hertzen Research Oncological Institute
Moscow, Russia
Medical Radiological Research Center
Obninsk, Russia
Clinical Center of Serbia
Belgrade, Serbia
Oncology Institute Belgrade
Belgrade, Serbia
Oncology Institute
Belgrade, Serbia
Institute for Oncology
Kamenitz, Serbia
Clinical Center
Niš, Serbia
FNsP - akad L. Derea Urology
Bratislava, Slovakia
FNsP Dep of Urology
Košice, Slovakia
FN sP Dep of Urology
Martin, Slovakia
University Clinical Center
Ljubljana, Slovenia
Gh, Dep of Urology
Maribor, Slovenia
Turret House
Claremont, South Africa
Johannesburg Hospital Dep of Urology
Johannesburg, South Africa
St. Annes Hospital
Pietermaritzburg, South Africa
Urological Hospital
Pretoria, South Africa
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bobak Djavan, Prof
Univ. Klinik für Urologie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 20, 2006
First Posted
February 22, 2006
Study Start
December 1, 2003
Primary Completion
December 1, 2003
Study Completion
November 1, 2007
Last Updated
May 1, 2012
Record last verified: 2012-04