Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone Metastasis (UCDCC#217)
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, Davis
Collaborator:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00918645
First received: June 10, 2009
Last updated: April 17, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Metastatic Cancer Prostate Cancer |
Drug: 41 Ca |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Measurement of Ca Kinetics in Humans With Prostate Cancer-induced Bone Disease |
Resource links provided by NLM:
Further study details as provided by University of California, Davis:
Primary Outcome Measures:
- Pharmacokinetics [ Time Frame: Samples will be collected over 18 months ] [ Designated as safety issue: No ]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:
- Disease parameters [ Time Frame: Samples will be collected over 18 months ] [ Designated as safety issue: No ]Correlate modulations in baseline urinary 41Ca clearance with changes in clinically relevant disease parameters, including isotope bone scan data and prostate specific antigen.
- Stratification of disease stage [ Time Frame: Samples will be collected over 18 months ] [ Designated as safety issue: No ]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.
| Enrollment: | 12 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 41 Ca |
Drug: 41 Ca
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.
Other Name: calcium-41 (41Ca) chloride aqueous solution
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918645
Locations
| United States, California | |
| Lawrence Livermore National Laboratory | |
| Livermore, California, United States, 94550 | |
Sponsors and Collaborators
University of California, Davis
Investigators
| Principal Investigator: | Darren Hillegonds, PhD | Lawrence Livermore National Laboratory at University of California |
| Principal Investigator: | Primo N. Lara, MD | University of California, Davis |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00918645 History of Changes |
| Other Study ID Numbers: | CDR0000628784, R21CA127671, P30CA093373, UCDCC-217 |
| Study First Received: | June 10, 2009 |
| Last Updated: | April 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, Davis:
|
stage IV prostate cancer recurrent prostate cancer bone metastases |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Prostatic Neoplasms Neoplastic Processes Pathologic Processes |
Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013