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

Primary Purpose

Metastatic Cancer, Prostate Cancer

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

41 Ca

About this trial

This is an interventional diagnostic trial for Metastatic Cancer focused on measuring stage IV prostate cancer, recurrent prostate cancer, bone metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

Lawrence Livermore National Laboratory

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

41 Ca

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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

Measure baseline 41Ca clearance and correlate with number of baseline bone metastasis lesions.

Full Information

NCT ID

NCT00918645

First Posted

June 10, 2009

Last Updated

December 1, 2017

Sponsor

University of California, Davis

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00918645

Brief Title

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

Acronym

UCDCC#217

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Terminated

Study Start Date

September 2009 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, Davis

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Cancer, Prostate Cancer

Keywords

stage IV prostate cancer, recurrent prostate cancer, bone metastases

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

41 Ca

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

41 Ca

Other Intervention Name(s)

calcium-41 (41Ca) chloride aqueous solution

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Patients Whose Samples Were Measured for Pharmacokinetics

Description

Time Frame

Samples will be collected over 18 months

Secondary Outcome Measure Information:

Title

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

Description

Urinary 41Ca clearance will be measured and correlated with progression by RECIST 1.0 and/or PSA progression of 100% over patient nadir.

Time Frame

Samples will be collected over 18 months

Title

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

Description

Measure baseline 41Ca clearance and correlate with number of baseline bone metastasis lesions.

Time Frame

Samples will be collected over 18 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Darren Hillegonds, PhD

Organizational Affiliation

Lawrence Livermore National Laboratory at University of California

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Primo N. Lara, MD

Organizational Affiliation

University of California, Davis

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lawrence Livermore National Laboratory

City

Livermore

State/Province

California

ZIP/Postal Code

94550

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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