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

Prostate Cancer Clinical Trial

— UCDCC#217  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00918645
• Other study ID #: CDR0000628784
• Secondary ID: R21CA127671P30CA
• Status: Terminated
• Phase: N/A
• First received: June 10, 2009
• Last updated: December 1, 2017
• Start date: September 2009
• Est. completion date: June 2013

Study information

• Verified date: December 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Lawrence Livermore National Laboratory	Livermore	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

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