Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone Metastasis
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.
- 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.
Masking: Open Label, Primary Purpose: Diagnostic
imaging biomarker analysis, laboratory biomarker analysis, pharmacological study, bone scan, scintigraphy, calcium-41 chloride aqueous solution, calcium-46 chloride aqueous solution
Not yet recruiting
National Cancer Institute (NCI)
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00918645
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Analysis based on the mathematical function first formulated by Jean-Baptiste-Joseph Fourier in 1807. The function, known as the Fourier transform, describes the sinusoidal pattern of any fluctuating pattern in the physical world in terms of its amplitude and its phase. It has broad applications in biomedicine, e.g., analysis of the x-ray crystallography data pivotal in identifying the double helical nature of DNA and in analysis of other molecules, including viruses, and the modified back-projection algorithm universally used in computerized tomography imaging, etc. (From Segen, The Dictionary of Modern Medicine, 1992)
Costs And Cost Analysis
Absolute, comparative, or differential costs pertaining to services, institutions, resources, etc., or the analysis and study of these costs.
A method of chemical analysis based on the detection of characteristic radionuclides following a nuclear bombardment. It is also known as radioactivity analysis. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)
The N-glucuronide conjugate of cotinine is a major urinary metabolite of NICOTINE. It thus serves as a biomarker of exposure to tobacco SMOKING. It has CNS stimulating properties.
A set of techniques used when variation in several variables has to be studied simultaneously. In statistics, multivariate analysis is interpreted as any analytic method that allows simultaneous study of two or more dependent variables.
RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors learn about changes that occur in DNA and identify biomarkers related to c...
RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer...
RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers relate...
RATIONALE: Monoclonal antibodies, such as CP-751871, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help ki...
RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimu...
CE coupled MS (CE-MS) has become an increasingly employed technology in proteome analysis with focus on the identification of biomarker peptides in clinical proteomics. In this review, we will cover t...
ABSTRACT: Atrophy measured on structural magnetic resonance imaging (sMRI) is a powerful biomarker of the stage and intensity of the neurodegenerative aspect of Alzheimer's disease (AD) pathology. In...
To provide an overview of the basic principles of biomarker use in clinical oncology practice and discuss the range of biomarker forms (from genes to constitutional characteristics), biomarker functi...
A widening array of novel imaging biomarkers is being developed using ever more powerful clinical and preclinical imaging modalities. These biomarkers have demonstrated effectiveness in quantifying bi...
In this chapter we first describe the applications of matrix-assisted laser desorption/ionization (MALDI) mass spectrometry (MS) in biomarker discovery. After a summary of the general analysis pipelin...