Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone Metastasis (UCDCC#217)

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

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 Overview

• Status: Terminated
• Conditions: Prostate Cancer; Metastatic Cancer
• Intervention / Treatment: Drug: 41 Ca

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Livermore, California, United States, 94550
      • Lawrence Livermore National Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: calcium-41 (41Ca) chloride aqueous solution

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Darren Hillegonds, PhD, Lawrence Livermore National Laboratory at University of California; Principal Investigator: Primo N. Lara, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: June 10, 2009
• First Submitted That Met QC Criteria: June 10, 2009
• First Posted (Estimate): June 11, 2009

Study Record Updates

• Last Update Posted (Actual): December 22, 2017
• Last Update Submitted That Met QC Criteria: December 1, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: stage IV prostate cancer; recurrent prostate cancer; bone metastases
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: CDR0000628784; P30CA093373 (U.S. NIH Grant/Contract); R21CA127671 (U.S. NIH Grant/Contract); UCDCC-217 (Other Identifier: University of California Davis Cancer Center)