Paricalcitol in Treating Patients With Advanced Prostate Cancer and Bone Metastases

You may be eligible if

• Inclusion:
• Histologically or cytologically confirmed advanced adenocarcinoma of the prostate
• \- Radiographically proven bone metastasis from prostate cancer
• Androgen refractory disease (including anti-androgen withdrawal)
• Secondary hyperparathyroidism, defined as two parathyroid hormone (PTH) values \> 70 pg/mL, 14 days apart
• ECOG performance status 0-2
• Leukocytes ≥ 3,000/μL
• Absolute neutrophil count ≥ 1,500/μL
• Platelets ≥ 100,000/μL
• Total bilirubin normal
• AST/ALT ≤ 2.5 times upper limit of normal
• Creatinine clearance ≥ 60 mL/min
• Calcium normal
• 25-hydroxyvitamin D (25-OHD) ≥ 20 ng/mL
• 1,25(OH)\_2D normal
• Patients with serum 25-OHD indicative of vitamin D insufficiency are eligible provided they are treated with ergocalciferol to raise 25-OHD levels to 20 ng/mL prior to paricalcitol therapy
• More than 8 weeks since prior bisphosphonates
• More than 2 weeks since prior palliative radiotherapy
• More than 4 weeks since other prior therapy
• No more than one prior taxane-containing chemotherapy regimen for metastatic disease
• Multiple lines of prior therapy with hormonal agents allowed
• Concurrent corticosteroids allowed provided the dose remains stable during the study period
• Exclusion:
• Underlying metabolic bone disease or vitamin D deficiency
• History of hypercalcemia
• Concurrent uncontrolled illness or co-morbid condition (including psychiatric illness) that would interfere with study compliance
• Concurrent ergocalciferol supplementation
• Concurrent chemotherapy or hormonal therapy
• Concurrent investigational or commercial agents for the malignancy