Duration of Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Men With Metastatic CRPC

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

Bone is the most common site of metastases in prostate cancer and bone complications cause substantial morbidity to this population. Phase III studies have shown that zoledronic acid is effective in decreasing the morbidity associated with bone metastases. Zoledronic acid (ZA) is generally well tolerated but may have side effects such as hypocalcemia, renal impairment and osteonecrosis of the jaw. Administration of ZA as infrequently as once yearly is sufficient to prevent osteopenia or osteoporosis. The optimal treatment interval is unknown, but the drug is often empirically administered every 3-4 weeks. The cost of such treatment is high, and the risk of exposing patients (especially those at low risk) to potential serious side effects with uncertain benefit warrants investigation. This study will determine the duration of suppression of bone turnover in prostate cancer patients with bone metastases following a single infusion of Zoledronic Acid and its effect on quality of life.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• Patients must have histologically confirmed prostate cancer that has become castration resistant

• Radiological or pathological evidence of bone metastases. (Positive bone scan, MRI, or CT or pathological fracture, or pathological sample from bone biopsy showing evidence of metastatic prostate cancer)

• Patient has not yet started on BP therapy for metastatic castration resistant prostate cancer

• Renal and hepatic function within the institutional normal range or at the discretion of the Investigator

• Age ≥ 18 years

• ECOG performance status ≤ 2

• Life expectancy >6 months

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Hypersensitivity or known allergy to bisphosphonates

• Patient who has received BP therapy for any reason within the past 1 year

• Acute or chronic renal insufficiency

• Evidence of infection/abscess on dental exam or recent dental extraction (within last 4 weeks)

• Acute pathological fracture, spinal cord compression, or hypercalcemia requiring urgent treatment (patient may enter study after acute issues are resolved)

• Patients with baseline hypocalcemia