Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases

NCT00219219 | Completed Phase 4

• 1 other identifier: CZOL446EIT04
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will give information about the course over time in skeletal-related events (SRE) in prostate cancer patients with bone metastases treated with zoledronic acid 4 mg administered as a 15-minute infusion every 4 weeks for a maximum of 15 infusions. The protocol will enroll patients with recent diagnosis of bone metastases from prostate cancer who are hormone-refractory, hormone-naïve or still hormone-sensitive, that represent the entire population of prostate cancer patients

Conditions

Prostate Cancer

Keywords

zoledronic acid; prostate cancer; SRE

Outcome Measures

Primary Outcomes (1)

• occurence of skeletale related events (SREs) over time (time to first SRE,skeletal morbidity rate and proportion of patients experiencing SRE)

Secondary Outcomes (3)

• Bone pain

• Use of analgesic medication and ECOG performance status every three months

• Bone specific alkaline phosphatase, serum N-telopeptide and parathyroid hormone will be evaluated after one month of treatment and then every three months

Interventions

Zoledronic acid DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 years
• Written informed consent
• Histologically-proven prostate carcinoma
• ECOG performance status ≤ 2
• Life expectancy \> 6 months
• Newly diagnosed (≤ 6 months prior to visit 1) bone metastases evidenced by bone scan or radiograph.
• Patients on androgen deprivation therapy (medical therapy with LHRH analogues + antiandrogens or surgical castration) or going to start it
• Patients with partners of childbearing potential should use a barrier method of contraception throughout the study

You may not qualify if:

• Patients without a history of metastatic disease to the bone
• Prior treatment with bisphosphonates
• SREs prior to visit 2
• Prior treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to baseline
• Corrected (adjusted for serum albumin - see Appendix 5 for the calculation) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/l)
• Serum creatinine concentration \> 265 micromol/l (3.0 mg/dl) or a calculated creatinine clearance \< 30 ml/minute or serious underlying renal disease or prior renal transplantation
• History of other malignant neoplasm within previous five years with exception of non-melanomatous skin cancer which has been satisfactorily treated
• Other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future
• Patients treated with systemic investigational drug(s) and/or device(s) within the past 30 days or topical investigational drugs within the past 7 days
• Known hypersensitivity to zoledronic acid or other bisphosphonates
• History of noncompliance to medical regimens and patients who are considered potentially unreliable (for example drug or alchohol abusers) or incapable of giving informed consent as judged by the investigator

Sponsors & Collaborators

• Novartis: lead
• Società Italiana di Urologia (SIU): collaborator

Study Sites (1)

Bologna

Bologna, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis

  Novartis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2003
• Study Completion: October 1, 2006
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

IT (1)