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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, Davis

Brief 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.


Condition or disease Intervention/treatment Phase
Metastatic Cancer Prostate Cancer Drug: 41 Ca Not Applicable

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  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


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 Name: calcium-41 (41Ca) chloride aqueous solution




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Locations
United States, California
Lawrence Livermore National Laboratory
Livermore, California, United States, 94550
Sponsors and Collaborators
University of California, Davis
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

Additional Information:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00918645     History of Changes
Other Study ID Numbers: CDR0000628784
R21CA127671 ( U.S. NIH Grant/Contract )
P30CA093373 ( U.S. NIH Grant/Contract )
UCDCC-217 ( Other Identifier: University of California Davis Cancer Center )
First Posted: June 11, 2009    Key Record Dates
Results First Posted: December 22, 2017
Last Update Posted: December 22, 2017
Last Verified: December 2017

Keywords provided by University of California, Davis:
stage IV prostate cancer
recurrent prostate cancer
bone metastases

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs