ZOMETA® (Zoledronic Acid) for Prevention of Bone Metastases - Full Text View

Sponsored by:	Central European Cooperative Oncology Group
Information provided by:	Central European Cooperative Oncology Group
ClinicalTrials.gov Identifier:	NCT00294437

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: Zometa	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Central European Cooperative Oncology Group:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	376
Study Start Date:	December 2003

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294437

Show 57 Study Locations

Sponsors and Collaborators

Central European Cooperative Oncology Group

Investigators

Principal Investigator:

Bobak Djavan, Prof

Univ. Klinik für Urologie

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	CECOG/prostate 1.2.001
Study First Received:	February 20, 2006
Last Updated:	May 10, 2007
ClinicalTrials.gov Identifier:	NCT00294437
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Central European Cooperative Oncology Group:

Prostate Cancer
Zometa

Study placed in the following topic categories:

Zoledronic acid
Prostatic Diseases
Genital Neoplasms, Male
Neoplasm Metastasis

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009