Prostate Cancer Clinical Trial
Official title:
Measurement of Ca Kinetics in Humans With Prostate Cancer-induced Bone Disease
RATIONALE: Diagnostic procedures, such as radionuclide imaging using calcium-41 (41Ca)
chloride aqueous solution, may help predict progressive disease in patients with prostate
cancer and bone metastasis.
PURPOSE: This clinical trial is studying how well calcium-41 (41Ca) chloride aqueous solution
works in diagnosing patients with prostate cancer and bone metastasis.
OBJECTIVES:
Primary
- To measure the pharmacokinetics of a single oral dose of calcium-41 (41Ca) chloride
aqueous solution (^41Ca) over 18 months in patients with hormone-refractory prostate
cancer and bone metastasis.
- To correlate the ^41Ca-tracer kinetics with time to disease progression,
skeletal-related events, and death.
Secondary
- To correlate modulations in baseline urinary ^41Ca clearance with changes in clinically
relevant disease parameters, including isotope bone scan data and PSA.
- To combine bone turnover assessments with ^41Ca and collagen/bone cell biomarkers with
clinical imaging techniques, especially isotope bone scans, to provide improved
stratification of disease stage.
OUTLINE: Patients receive oral calcium-41 (41Ca) chloride aqueous solution (^41Ca) on day 1.
Some patients also receive oral calcium-46 (46Ca) chloride aqueous solution (^46Ca).
Urine and blood specimens are collected periodically for 18 months. Blood samples are assayed
for bone collagen residues, bone alkaline phosphatase, and PSA. Urine specimens are assessed
for ^41Ca/Ca. Isotope bone scintigraphy is use to measure radioactivity.
After completion of study treatment, patients are followed up periodically for 3 years.
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