Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone … (NCT00918645) | Clinical Trial Compass
TerminatedNot Applicable
Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone Metastasis
United States13 participantsStarted 2009-09
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Number of Patients Whose Samples Were Measured for Pharmacokinetics
Timeframe: Samples will be collected over 18 months