Clinical trial · Interventional
Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone Metastasis
Measurement of Ca Kinetics in Humans With Prostate Cancer-induced Bone Disease
NCT00918645CI-TRIAL-00030893UCDCC#217terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 41 Ca | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 41 Ca
- interventionNames
- Drug: 41 Ca
Primary outcomes (1)
- measure
- Number of Patients Whose Samples Were Measured for Pharmacokinetics
- timeFrame
- Samples will be collected over 18 months
- description
- 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 outcomes (2)
- measure
- Number of Patients With Urinary 41Ca Clearance Correlated to Disease Progression
- timeFrame
- Samples will be collected over 18 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.