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

NCT00918645 | Terminated Results DMC

• 4 other identifiers: CDR0000628784R21CA127671P30CA093373UCDCC-217
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Cancer; Prostate Cancer

Keywords

stage IV prostate cancer; recurrent prostate cancer; bone metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Patients With Urinary 41Ca Clearance Correlated to Disease Progression

  Samples will be collected over 18 months

• Number of Patients With Correlation Between 41Ca Clearance and Disease Stage

  Samples will be collected over 18 months

Study Arms (1)

41 Ca

EXPERIMENTAL

Drug: 41 Ca

Interventions

41 Ca DRUG

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.

Also known as: calcium-41 (41Ca) chloride aqueous solution

41 Ca

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Lawrence Livermore National Laboratory

Livermore, California, 94550, United States

Location

Related Links

• Abstract

MeSH Terms

Conditions

Neoplasm Metastasis; Prostatic Neoplasms

Interventions

Calcium-41

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Limitations and Caveats

This trial was IRB closed after accruing only 13 patients of a potential 30 due to contract period expiring. This termination prior to accrual goal achievement led to small numbers of subjects analyzed with no statistical analysis done.

Results Point of Contact

• Title: Data Manager
• Organization: University of California, Davis

nmahaffey@ucdavis.edu

916-734-8381

Study Officials

• Darren Hillegonds, PhD

  Lawrence Livermore National Laboratory at University of California

  PRINCIPAL INVESTIGATOR

• Primo N. Lara, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 11, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 22, 2017
• Results First Posted: December 22, 2017

Record last verified: 2017-12

Locations

US (1)