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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219219
• Other study ID #: CZOL446EIT04
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: April 13, 2015
• Start date: September 2003
• Est. completion date: October 2006

Study information

• Verified date: April 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Zoledronic acid

Locations

Country	Name	City	State
Italy	Bologna	Bologna

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Società Italiana di Urologia (SIU)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurence of skeletale related events (SREs) over time (time to first SRE,skeletal morbidity rate and proportion of patients experiencing SRE)
Secondary	Bone pain
Secondary	Use of analgesic medication and ECOG performance status every three months
Secondary	Bone specific alkaline phosphatase, serum N-telopeptide and parathyroid hormone will be evaluated after one month of treatment and then every three months