ZOMETA® (Zoledronic Acid) for Prevention of Bone Metastases
- Registration Number
- NCT00294437
- Lead Sponsor
- Central European Cooperative Oncology Group
- 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.
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 376
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description zoledronic acid Zometa Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months
- Primary Outcome Measures
Name Time Method Time to occurrence of first bone metastasis, as assessed by bone scan and confirmed by additional radiological examination
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (54)
Clinical Center
🇷🇸Nis, Serbia
GH, Dep Oncology and Reumatology
🇭🇷Varazdin, Croatia
Clinical Hospital
🇭🇷Zagreb, Croatia
Univ. Hospital, Dep of Pathophysiology
🇭🇷Split, Croatia
Univ. of Pecs,Urologic Clinic
🇭🇺Pecs, Hungary
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Gh, Dep of Urology
🇸🇮Maribor, Slovenia
Urological Hospital
🇿🇦Pretoria, South Africa
Lithuanian Oncology Center
🇱🇹Vilnius, Lithuania
Medical Radiological Research Center
🇷🇺Obninsk, Russian Federation
Thermenkh Baden, Urologie
🇦🇹Baden bei Wien, Austria
KH d Elisabethinen Linz, Dep of Urology
🇦🇹Linz, Austria
KH der Barmherzigen Schwestern, Dept Urologie
🇦🇹Linz, Austria
Semmelweiss Univ of Medicine, Clinic of Urology
🇭🇺Budapest, Hungary
Dept. Of Urology and Surgery
🇭🇺Szombathely, Hungary
Centrum Onkologii Instytut
🇵🇱Krakow, Poland
P.D.R. Clinic
🇷🇴Brasov, Romania
Fundeni Hospital, Dep of Urology
🇷🇴Bucharest, Romania
Institutul Oncologic Cluj
🇷🇴Cluj-Napoca, Romania
University Hospital
🇷🇴Iasi, Romania
Hertzen Research Oncological Institute
🇷🇺Moscow, Russian Federation
Oncology Institute Belgrade
🇷🇸Belgrade, Serbia
FNsP - akad L. Derea Urology
🇸🇰Bratislava, Slovakia
FN sP Dep of Urology
🇸🇰Martin, Slovakia
Johannesburg Hospital Dep of Urology
🇿🇦Johannesburg, South Africa
Turret House
🇿🇦Claremont, South Africa
St. Annes Hospital
🇿🇦Pietermaritzburg, South Africa
LKH Innsbruck, Dept f. Urologie
🇦🇹Innsbruck, Austria
SBALO National Oncology Center
🇧🇬Sofia, Bulgaria
Modozs-Veliko
🇧🇬Tarnovo, Bulgaria
Hospital Kromeriz, Dep of Urology
🇨🇿Kromeriz, Czech Republic
Centre of Oncology
🇨🇿Usti Nad Labem, Czech Republic
Mustamae Korpus
🇪🇪Tallinn, Estonia
Clinic of surgery
🇪🇪Tartu, Estonia
karolyi sandor Hospital, Dept of Urology
🇭🇺Budapest, Hungary
LKH Leoben, Abt. für Innere Medizin
🇦🇹Leoben, Steiermark, Austria
Plovdiv Cancer Center
🇧🇬Plovdiv, Bulgaria
FN Motol, Dep of Urology
🇨🇿Prague, Czech Republic
Saint John Emergency Clinical Hospital
🇷🇴Bucharest, Romania
Emergency Clinical County Hospital , Clin Oncol. Dep
🇷🇴Craiova, Romania
Oncological Hospital
🇧🇬Varna, Bulgaria
Dept. Of Urology , Jahn Ferenc Delpesti Hospital
🇭🇺Budapest, Hungary
LKH Salzburg, Clinic f Radiotherapy a Radiooncology
🇦🇹Salzburg, Austria
Sofia Cancer Center compl. Mladost ,
🇧🇬Sofia, Bulgaria
Clinical Center of Montenegro
🇲🇪Podgorica, Montenegro
Oncology Institute
🇷🇸Belgrade, Serbia
Institute for Oncology
🇷🇸Sremska Kamenica, Serbia
MODOSZ Oncology Dispensary
🇧🇬Stara Zagora, Bulgaria
Medical Academy
🇵🇱Warsaw, Poland
Central Rail Hospital,
🇵🇱Warsaw, Poland
LKH Graz Univ. Klinik f Urologie
🇦🇹Graz, Austria
FH, Urological Clinic
🇨🇿Brno, Czech Republic
FNsP Dep of Urology
🇸🇰Kosice, Slovakia
University Clinical Center
🇸🇮Ljubljana, Slovenia