Measurement of Ca Kinetics in Humans With Prostate Cancer-induced Bone Disease
- 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.
- 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.
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Pre-dose specimens will be provided immediately prior to dose administration. Day 1 specimens shall be collected by the subjects 6 hours after dosing (at home); all subsequent urine specimens may be collected at any time during the day and blood specimens should be taken at the same time of day, if feasible (e.g., morning fasted).
Samples will be collected over 18 months
Darren Hillegonds, PhD
Lawrence Livermore National Laboratory at University of California
United States: Food and Drug Administration
|Lawrence Livermore National Laboratory||Livermore, California 94550|