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

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium; Calcium, Dietary

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)