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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00918645
First received: June 10, 2009
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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 Intervention
Metastatic Cancer
Prostate Cancer
Drug: 41 Ca

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Measurement of Ca Kinetics in Humans With Prostate Cancer-induced Bone Disease

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Samples will be collected over 18 months ] [ Designated as safety issue: No ]
    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:
  • Disease parameters [ Time Frame: Samples will be collected over 18 months ] [ Designated as safety issue: No ]
    Correlate modulations in baseline urinary 41Ca clearance with changes in clinically relevant disease parameters, including isotope bone scan data and prostate specific antigen.

  • Stratification of disease stage [ Time Frame: Samples will be collected over 18 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: September 2009
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918645

Locations
United States, California
Lawrence Livermore National Laboratory
Livermore, California, United States, 94550
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Darren Hillegonds, PhD Lawrence Livermore National Laboratory at University of California
Principal Investigator: Primo N. Lara, MD University of California, Davis
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00918645     History of Changes
Other Study ID Numbers: CDR0000628784, R21CA127671, P30CA093373, UCDCC-217
Study First Received: June 10, 2009
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Prostatic Neoplasms
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 23, 2014