Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone Metastasis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Measurement of Ca Kinetics in Humans With Prostate Cancer-induced Bone Disease

Conditions
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Metastatic Cancer, Prostate Cancer

Intervention / Treatment
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* Drug: 41 Ca


Participation Criteria
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Eligibility Criteria
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Eligibility Criteria Histologically or cytologically confirmed prostate cancer with a Gleason score available or interpretable Prostate cancer deemed to be hormone refractory or androgen independent within the past 12 months Evidence of bony metastasis Either be receiving bisphosphonate therapy or have received a bisphosphonate within the last 18 months. Participants who are on not on bisphosphonate therapy nor have received it within the last 18 months should currently be on Denosumab therapy. All other anti-cancer therapies are allowed. Age >18 years ECOG performance status 0-2 (Karnofsky >50%). Life expectancy of 6 months or greater. Investigators are encouraged to follow good medical practice to assure that all participants have adequate hematologic, hepatic, and renal function. Recent or planned isotope bone scan, within 12 months prior to enrollment. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria Participants will be excluded who have experienced a severe skeletal related event (SRE)within the past 3 months. For this study, an SRE consists of any of the following: palliative radiotherapy to bone, pathologic fractures, spinal cord compression, hypercalcemia of malignancy, and surgery to bone to treat or prevent a fracture. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, chronic kidney disease, hyperthyroidism, or psychiatric illness/social situations that would limit compliance with study requirements. Corrected serum calcium <8.0 mg/dL (2.0 mmol/L) or ≥12.0 mg/dL (3.0 mmol/L)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 41 Ca<br> | Drug: 41 Ca<br>* 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.<br>* Other names: calcium-41 (41Ca) chloride aqueous solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Whose Samples Were Measured for Pharmacokinetics | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Urinary 41Ca Clearance Correlated to Disease Progression | Urinary 41Ca clearance will be measured and correlated with progression by RECIST 1.0 and/or PSA progression of 100% over patient nadir. | Samples will be collected over 18 months | 
| Number of Patients With Correlation Between 41Ca Clearance and Disease Stage | Measure baseline 41Ca clearance and correlate with number of baseline bone metastasis lesions. | Samples will be collected over 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV prostate cancer, recurrent prostate cancer, bone metastases