Status:
COMPLETED
Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
An open, multicenter and prospective study to evaluate the impact of the treatment with zoledronic acid 4 mg, on the quality of life and the skeletal-related events in patients with prostate cancer an...
Eligibility Criteria
Inclusion
- Age ≥18
- histologically confirmed adenocarcinoma of the prostate.
- Orchidectomy within the four previous weeks to enter the study.
- bone metastasis evidenced by bone scan.
- A hip DEXA study with a DS \< 3.
- No hormonal therapy previous to enter the study.
- ECOG performance score of 0-2.
- Signed written informed consent.
Exclusion
- Abnormal renal function evidenced by a creatinine clearance ≤60 ml/min.
- Any kind of hormonal therapy for prostate cancer previous to enter the study.
- Serum calcium corrected for albumin level \< 8.0 mg/dl.
- WBC \< 3.0x10\^3, ANC \< 1500/mm3, Hemoglobin \< 8.0 g/dl, platelets \< 75 x 10\^3/l.
- Abnormal hepatic function evidenced by ALT and AST value \>2.5 UNL
- Subjects with any other malignant disease that can affect the bone.
- Subjects with any other non malignant disease that can jeopardize the evaluation of the primary objectives of this trial (severe osteoporosis) or that do not aloud perform the trial evaluations.
- Known hypersensibility to zoledronic acid or other bisphosphonates.
- Subjects that in the investigator's opinion can not cooperate with the protocol.
- Other protocol inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00237146
Start Date
November 1 2003
End Date
March 1 2008
Last Update
February 23 2017
Active Locations (1)
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1
Novartis Investigative Site
Caracas, Venezuela