Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone Metastasis (UCDCC#217)
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|ClinicalTrials.gov Identifier: NCT00918645|
Recruitment Status : Terminated
First Posted : June 11, 2009
Results First Posted : December 22, 2017
Last Update Posted : December 22, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Prostate Cancer||Drug: 41 Ca||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Measurement of Ca Kinetics in Humans With Prostate Cancer-induced Bone Disease|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||June 2013|
|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
- Number of Patients Whose Samples Were Measured for 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).
- Number of Patients With Urinary 41Ca Clearance Correlated to Disease Progression [ Time Frame: Samples will be collected over 18 months ]Urinary 41Ca clearance will be measured and correlated with progression by RECIST 1.0 and/or PSA progression of 100% over patient nadir.
- Number of Patients With Correlation Between 41Ca Clearance and Disease Stage [ Time Frame: Samples will be collected over 18 months ]Measure baseline 41Ca clearance and correlate with number of baseline bone metastasis lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|