Status:
TERMINATED
Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone Metastasis
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Cancer
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 metasta...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00918645
Start Date
September 1 2009
End Date
June 1 2013
Last Update
December 22 2017
Active Locations (1)
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1
Lawrence Livermore National Laboratory
Livermore, California, United States, 94550