Metastatic CancerUCDCC#217NCT00918645
Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone Metastasis
A study testing 41 Ca in people with Metastatic Cancer and Prostate Cancer, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Cancer, Prostate Cancer
- What is being tested?
- 41 Ca
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Lawrence Livermore National Laboratory
Livermore, California, 94550
About this study
Official title: Measurement of Ca Kinetics in Humans With Prostate Cancer-induced Bone Disease
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.
Read the 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.
- Conditions
- Metastatic Cancer, Prostate Cancer
- Being tested
- 41 Ca
- Keywords
- stage IV prostate cancer, recurrent prostate cancer, bone metastases
- Medical subject headings
- Neoplasm Metastasis, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
41 CaDrug
Also called calcium-41 (41Ca) chloride aqueous solution
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.
| Study group | Role | What they receive |
|---|---|---|
| 41 Ca | Experimental | Not described Receives: Drug: 41 Ca |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Whose Samples Were Measured for Pharmacokinetics
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).
Measured: Samples will be collected over 18 months
Secondary outcomes (2)
Number of Patients With Urinary 41Ca Clearance Correlated to Disease Progression
Urinary 41Ca clearance will be measured and correlated with progression by RECIST 1.0 and/or PSA progression of 100% over patient nadir.
Measured: Samples will be collected over 18 months
Number of Patients With Correlation Between 41Ca Clearance and Disease Stage
Measure baseline 41Ca clearance and correlate with number of baseline bone metastasis lesions.
Measured: Samples will be collected over 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Darren Hillegonds, PhD, Principal investigator, Lawrence Livermore National Laboratory at University of CaliforniaPrimo N. Lara, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918645
- Sponsor's protocol ID
- CDR0000628784
- Other IDs
- R21CA127671, P30CA093373, UCDCC-217
- Acronym
- UCDCC#217
- Status last verified
- Dec 2017
- First submitted
- 10 Jun 2009
- Last updated
- 22 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Ca Kinetics in Humans With Prostate Cancer-induced Bone Disease
- ClinicalTrials.gov ID
- NCT00918645
- Acronym / sponsor ID
- UCDCC#217 / CDR0000628784
- Conditions
- Metastatic Cancer, Prostate Cancer
- Keywords
- stage IV prostate cancer, recurrent prostate cancer, bone metastases
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Posted 22 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 41 Ca | Experimental | Drug: 41 Ca |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 41 CaAlso: calcium-41 (41Ca) chloride aqueous solutionsingle 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. | Drug | 41 Ca |
Primary outcome
Number of Patients Whose Samples Were Measured for Pharmacokinetics
Time frame: Samples will be collected over 18 months
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).
2 secondary outcomes
Number of Patients With Urinary 41Ca Clearance Correlated to Disease Progression
Time frame: Samples will be collected over 18 months
Number of Patients With Correlation Between 41Ca Clearance and Disease Stage
Time frame: Samples will be collected over 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AbstractLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Hillegonds, PhD principal investigator
Lawrence Livermore National Laboratory at University of California
Primo N. Lara, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 41 Ca in people with Metastatic Cancer and Prostate Cancer, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Whose Samples Were Measured for Pharmacokinetics (time frame: Samples will be collected over 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.