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
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: Zoledronic acid (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
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 and bone metastasis that responds to hormonal therapy. Zoledronic acid
is given to patients in a 15 minute-infusion every 4 weeks until a skeletal-related event
occurs.
Clinical Details
Official title: 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.
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Evaluate the effects of Zometa® (Zoledronic Acid) i.v in doses of 4mg for measure the following parameters of efficacy: Quality of Life, Incidence of Events related to the skeleton
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Novartis Investigative Site, Caracas, Venezuela
Additional Information
Starting date: November 2003
Last updated: February 11, 2013
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