Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone Metastasis (UCDCC#217)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Measurement of Ca Kinetics in Humans With Prostate Cancer-induced Bone Disease|
- Pharmacokinetics [ Time Frame: Samples will be collected over 18 months ]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).
- Disease parameters [ Time Frame: Samples will be collected over 18 months ]Correlate modulations in baseline urinary 41Ca clearance with changes in clinically relevant disease parameters, including isotope bone scan data and prostate specific antigen.
- Stratification of disease stage [ Time Frame: Samples will be collected over 18 months ]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.
|Study Start Date:||September 2009|
|Study Completion Date:||June 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Experimental: 41 Ca||
Drug: 41 Ca
single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.
Other Name: calcium-41 (41Ca) chloride aqueous solution
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918645
|United States, California|
|Lawrence Livermore National Laboratory|
|Livermore, California, United States, 94550|
|Principal Investigator:||Darren Hillegonds, PhD||Lawrence Livermore National Laboratory at University of California|
|Principal Investigator:||Primo N. Lara, MD||University of California, Davis|