Clinical trial NCT00219219: Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases
Official title: Zoledronic Acid in the Prevention of Skeletal-related Events in Hormone Refractory and Hormone-sensitive Prostate Cancer Patients With Bone Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: zoledronic acid
prostate cancer
SRE
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Società Italiana di Urologia (SIU)
First posted: 2005-09-22
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: occurence of skeletale related events (SREs) over time (time to first SRE,skeletal morbidity rate and proportion of patients experiencing SRE)
Secondary outcomes:
measure: Bone pain
measure: Use of analgesic medication and ECOG performance status every three months
measure: Bone specific alkaline phosphatase, serum N-telopeptide and parathyroid hormone will be evaluated after one month of treatment and then every three months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Bologna
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References: