Status:
TERMINATED
ZOMETA® (Zoledronic Acid) for Prevention of Bone Metastases
Lead Sponsor:
Central European Cooperative Oncology Group
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
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, p...
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 mont...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT00294437
Start Date
December 1 2003
End Date
November 1 2007
Last Update
May 1 2012
Active Locations (57)
Enter a location and click search to find clinical trials sorted by distance.
1
LKH Leoben, Abt. für Innere Medizin
Leoben, Styria, Austria, 8700
2
Thermenkh Baden, Urologie
Baden, Austria
3
LKH Graz Univ. Klinik f Urologie
Graz, Austria
4
LKH Innsbruck, Dept f. Urologie
Innsbruck, Austria